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pdfAppendix C
Additional Study Documentation
Appendix C.1
Deleted
Appendix C.2
Hypotheses Topics
Appendix C
C.2–1
Hypotheses Topics of the National Children’s Study
Birth defects from impaired glucose metabolism
Increased risk of preterm birth from intrauterine exposure to mediators of inflammation
Increased risk of fetal growth restriction, preterm birth, birth defects and developmental disabilities
in children born through assisted reproductive technologies
Maternal subclinical hypothyroidism and neurodevelopmental disabilities/adverse pregnancy
outcomes
Non-persistent pesticides and poor neurobehavioral and cognitive skills
Prenatal infection and neurodevelopmental disabilities
Gene–environment interactions and behavior
Prenatal and perinatal infection and schizophrenia
Family influences on child health and development
Impact of neighborhood and communities on child health
Impact of media exposure on child health and development
Social institutions and child health and development
Influences on healthy development
The role of prenatal maternal stress and genetics in childhood asthma
Exposure to indoor and outdoor air pollution, aeroallergens, and asthma risk
Dietary antioxidants and asthma risk
Social environmental influences on asthma disparities
Early exposure to structural components and products of microorganisms decreases the risk of
asthma
Environmental exposures interact with genes to increase the risk of asthma and wheezing in children
Obesity and insulin resistance from impaired maternal glucose metabolism
Obesity and insulin resistance from intrauterine growth restriction
Breastfeeding associated with lower rates of obesity and lower risk of insulin resistance
Fiber, whole grains, high glycemic index and obesity and insulin resistance
Genetics, environmental exposures, and type 1 diabetes
Repeated mild traumatic brain injury and neurocognitive development
Behavioral exposures, genetics, and childhood or adolescence onset aggression
Antecedents and resiliency to traumatic life events in childhood
Hormonally active environmental agents and reproductive development
Source: NCS Research Plan, Version 1.3
Appendix C.3
Summary of Data Collection Activities
Appendix C
C.3.1–1
DRAFT
DRAFT
NCS PROTOCOL OVERVIEW AND SUMMARY OF CONTACTS
July 31, 2008
Pre- Pregnancy
P1
Home
Informed Consent/Detailed Visit Information/Medical
Release as Needed
M
Interviews/Assessments/Questionnaires
In-Person/Phone
Self-Administered Questionnaire
M
Within X
days of
1
P1
P
1 Month
(Phone)
M
Pregnancy
P
2 Month
(Phone)
M
Physical Exam
Anthropometric
Blood Pressure
Ultrasound
Infant Neonatal Exam
Infant Physical Exam
Lung Function
Physical Activity
Hearing Assessment
Vision Assessment
BIA
Biospecimen Collection
Pregnancy Tests (self-collected)
Vaginal Swabs
7
Blood / Buccal Cell
Blood Spot (heel)
Urine (self-collected)
Hair
Nails
Cord Blood
Umbilical Cord
Placenta
Meconium
Breast Milk (self-collected)
Saliva (self-collected)
M
T1-1st
(Home)
T1 - Prior
(Home)
MF
MF
MF
MF
M
Within X
Days of
1
T1
16-17
Weeks
(Phone)
T2
T3-Prior T3-1st
2
(Clinic) (Clinic) (Home)
Within X
days of 36 Weeks
1
T3
(Phone)
M
M
M
M
M
MF
Diaries/Medical Visit Logs
Medical Care Log
Environmental
Indoor Air
House Dust
Drinking Water
Soil
Visual Assessment
Indoor Air (self-collected)
House Dust (self-collected)
P
4 Month
(Phone)
Birth
M
M
M
M
*
M
M
*
M
M
M
M
M
M
M
M
M
1 month
visit if
3
needed
(Home)
3 Months
(Phone)
M
M
6 Month Within X
12 Month
days of 6 9 Months
Visit
Visit
1
(Home) Mo. Visit (Phone) (Home)
M
M
M
M
Post-natal
B2
Within X
B1
PreDelivery discharge weeks of
1
(Hospital) (Hospital)
B2
18 Mos.
(Phone)
24 Mos.
(Phone)
M
F
M
MF
MF
MC
M
Within X
days of
12 Mo.
1
Visit
MF
M
F
MFC
C
X
X
X
X
X
4
X
X
X
X
X
X
X
M
M4
M
M
MF
MF
MF
MF
5
M
M
M
M
M
M
8
M
Other
Medical Record - Ultrasound
Chart Abstraction - Prenatal, Labor, and Delivery
Chart Abstraction - Neonatal
Community Based Food, Air, and Water Collection
Child Care Locations
Neighborhood Assessment
KEY: M=MOTHER F=FATHER C=CHILD X=CHILD'S PLACE OF RESIDENCE
M
M
M
M
M
M
M
MF
M
MF
M
M
M
M
MF
F
F
MF
F
F
M
M
M
M
M
M
M
M
M
M6
C
C
C
C
C
C
C
C
C
C
C
C
M
C
C
M
M
C
C
M
M
9
C
MF
5
M
10
M
C
M
C
M
X10
M10
X
10
CC
CC
CC=CHILD'S CHILD CARE LOCATION(S)
1
Activity is initiated at in-person visit and requires participant action after the visit (e.g., mail in self-collected urine sample, complete self-administered questionnaire and mail in). Time frame for completion varies and is specific to each activity.
2
If a participant enrolls at 28 weeks or later, she will have a modified T3 visit in the home that includes obtaining some baseline measures from T1 visit as well as additional T3 protocol activities.
3
A home visit will be conducted at 1 month if certain child measures are not completed at the birth visit.
4
Self-collected environmental samples will not be collected if the T3 visit is the participant's first visit.
This ultrasound will only be conducted for women who do not already have a 1st trimester ultrasound as part of routine care (see protocol).
If the participant's first visit is the T3 visit, the T3 ultrasound will be done at a clinic, separate from the T3 home visit.
7
Buccal cells for DNA will be collected as a backup from the mother and father at the T1 First or Prior visit and the child at the 36 month visit when blood is not drawn.
8
These biospecimen collections are intended to measure environmental exposures closer to the time of conception and includes two separate collection
9
The saliva will be collected from the mother and the 2nd adult caregiver in the home (not necessarily the father
10
Community samples and assessments will be collected at regular intervals throughout this time period. The collections/assessments are not connected to a specific visit.
* T1 air samples will be collected in a sub-study of participant and wll include personal air monitoring.
5
6
Revised 8/27/08
Appendix C
C.3.2–1
NCS PROTOCOL OVERVIEW
SUMMARY OF QUESTIONNAIRE AND PSYCHOLOGICAL/DEVELOPMENTAL ASSESSMENTS
August 25, 2008
DRAFT
Pre- Pregnancy
P1
Home
Informed Consent /Detailed Visit Information/ Medical Release As Needed
Within X
days of
P11
P
1 Month
(Phone)
Birth
Pregnancy
P
2 Month
(Phone)
M
P
4 Month
(Phone)
T1-1st2
(Home)
T1 - Prior
(Home)
MF
MF
2
Within X
Days of
T11
16-17
Weeks
(Phone)
T2
(Clinic)
DRAFT
Within X
T3-Prior T3-1st
36 Weeks
(Clinic) (Home)3 days of T31 (Phone)
M
B1
Delivery
(Hospital)
B2
Pre-discharge
(Hospital)
Post-natal
Within X
weeks of
B21
M
1 month visit
4
if needed
(Home)
3 Months
(Phone)
M
6 Month
Visit
(Home)
Within X days 9 Months
of 6 Mo. Visit 1 (Phone)
MF
12 Month
Visit
(Home)
Within X
days of 12
Mo. Visit 1
18 Mos.
(Phone)
24 Mos.
(Phone)
MF
Interview/Assessments
Household Composition and Demographics
Household Composition
M
M
Age, race, ethnicity, relationship, marital status
M
MF
Education
M
M
F
M
M
MF
F
M
Income (acasi)
M
M
M
M
Supported by family income (acasi)
M
M
M
M
Food security
M
MF
F
M
M
Health insurance
M
MF
F
M
M
Social Status
M
MF
F
M
M
MF
F
M
M
Religious affiliation
Culture and acculturation
Contact and Tracing
M
M
F
M
Perceived Stress
Global Perceived Stress
M
M
M
M
M
M
Racism/Discrimination
M
Life Events (self-administered)
Parenting Stress
M
Work/Family Stress
M
Social Support
M
M
M
M
M
M
Family Process
Quality of Relationships
M
Domestic Violence (acasi)
F
M
M
MF
M
M
Division of Labor
M
Health Behaviors (maternal)
Physical Activity
M
Maternal Sleep
M
M
Douching (acasi)
Caffeine Use
M
M
M
M
M
Tobacco Use (acasi)
M
M
Environmental Tobacco Smoke Exposure (acasi)
M
M
Alcohol Use (acasi)
M
Binge Drinking (acasi)
Illicit Drug Use and Abuse of Prescription Drugs (acasi)
M
M
M
M
M
M
M
M
M
M
M
M
F
M
F
M
M
Diet and Toxicant Exposure through Food (mother)
- Food Frequency Questionnaire (self-administered questionnaire)
M
M
M
- 3-Day Checklist (self-administered questionnaire)
M
M
M
M
M
Diet and Toxicant Exposures through Food (child)
- Child Feeding Form (mailed self-administered questionnaire)
M
M
M
M
M
- Child FFQ (mailed self-administered questionnaire)
M
- Child 3-day Checklist (mailed self-administered questionnaire)
M
Media Exposure in Children
M
M
Mental Health & Cognition
Depression
MF
MF
M
M
M
State Trait Anxiety
IQ
Literacy
Maternal / Paternal Attachment
F
M
F
F
F
M
F
M
Revised 8/27/08
1
Appendix C
C.3.2–2
NCS PROTOCOL OVERVIEW
SUMMARY OF QUESTIONNAIRE AND PSYCHOLOGICAL/DEVELOPMENTAL ASSESSMENTS
August 25, 2008
DRAFT
Pregnancy
Pre- Pregnancy
P1
Home
Within X
days of
P11
P
1 Month
(Phone)
P
2 Month
(Phone)
P
4 Month
(Phone)
T1-1st2
(Home)
T1 - Prior
(Home)
2
Within X
Days of
T11
16-17
Weeks
(Phone)
T2
(Clinic)
DRAFT
Birth
Within X
T3-Prior T3-1st
36 Weeks
(Clinic) (Home)3 days of T31 (Phone)
B1
Delivery
(Hospital)
B2
Pre-discharge
(Hospital)
Post-natal
Within X
weeks of
B21
1 month visit
4
if needed
(Home)
Child Care
3 Months
(Phone)
6 Month
Visit
(Home)
M
M
Within X days 9 Months
of 6 Mo. Visit 1 (Phone)
M
12 Month
Visit
(Home)
Within X
days of 12
Mo. Visit 1
M
18 Mos.
(Phone)
24 Mos.
(Phone)
M
M
M
Neighborhood
M
M
M
M
M
M
M
M
MF
MF
M
M
Commuting
M
M
Product Use Questionnaire
M
M
Pets
M
M
Financial Security and Program Participation
Housing Characteristics/In home exposures
Occupational/Hobby Exposures
M
M
M
F
M
M
M
M
M
M
M
Pesticide Use
M
M
M
M
M
M
M
M
M
M
M
Use of Medicines (child)
M
Time and Activity (mother) (self-administered questionnaire)
M
M
Use of Medicines (mother)
M
M
Take Home (Occupational) Exposures
M
M
F
M
M
M
M
M
M
M
Time and Activity (child)
M
M
M
M
M
M
M
M
M
M
M
M
Medical History (maternal/paternal)
Current Pregnancy Information
M
M
Use of Fertility Services
M
M
Biological father information
M
M
Prenatal Care, Doctor Visits, Hospitalizations
M
M
Birth History
M
M
M
M
Pregnancy and Reproductive History (acasi)
Medical History and Conditions
Dental Health
Family Medical History (self-administered questionnaire)
M
M
M
M
M
M
M
M
M
M
M
MF
MF
M
M
M
M
M
F
M
M
Medical History (child)
Persistent crying/Colic
M
Developmental milestones
M
M
M
MF
Parenting Practices/Behaviors
M
F
M
Major life events
M
Child Language Development
M
Child Temperament / Emotional Regulation
M
M
Child Socio-Emotional Functioning / Behavior
M
M
Child Autism Screening
M
Neurobehavioral Assessments
Neonatal Neurobehavior
C
C
General Cognitive Ability
MC
General Motor Development
C
Language Development
Parent-Child Interaction
KEY: M=MOTHER
C
MC
CF
F=FATHER C=CHILD
1
Activity is initiated at in-person visit and requires participant action after the visit (e.g., mail in self-collected urine sample, complete self-administered questionnaire and mail in). Time frame for completion varies and is specific to each activity.
2
T1 Prior measures and activities will be conducted with the respondents who were enrolled prior to conception and completed a P1 visit. The T1 First visit will be conducted with women who are enrolled during their 1st trimester of pregnancy.
3
If a participant enrolls at 28 weeks or later, she will have a modified T3 visit in the home that includes obtaining some baseline measures from T1 visit as well as additional T3 protocol activities.
4
This visit is only conducted if certain child measures are not completed at the B2 (pre-discharge) visit.
Revised 8/27/08
2
Appendix C
C.3.3-1
NCS Biospecimen Collections--January 2008
Pre- Pregnancy
Specimen Type
(amount collected)
Pregnancy
Post-natal
Birth
Within X
Days of
P1 Home
P1
T1 - 1st
(Home)
Within X
Within
T1 - Prior Days of T3 (Clinic X Days
(Home)
T1
or Home) of T3
44 mL
(6 tubes)
52.5 mL
(7 tubes)
52.5 mL
(7 tubes)
60.5 mL
(8 tubes)
40 mL
40 mL
40 mL
40 mL
X
X
X
B1
Delivery
(Hospital)
B2
Predischarge
(Hospital)
1 Month
Visit if
Needed
(Home)
3 Months
(Phone)
6-Month
Visit
(Home)
Within X 12-Month
Days of 6Visit
Mo. Visit (Home)
Within X
Days of
12-Mo.
Visit
Maternal
Blood
Spot Urine
Pregnancy Urine
33 mL
(4 tubes)
40 mL
**P1 study participants will be asked to collect a urine sample the
morning after their positive pregnancy test.
Vaginal Swabs (3 swabs)
X
Hair (~20 strands)
X
X
Nails (clippings from all toes)
X
Saliva (3 collections per day for 2 days)
X
X
X
Cord Blood
X
Placenta and Umbilical Cord (size measurements,
weight, photographs, tissue blocks, tissue samples)
X
Breast Milk (mL)
***A Breast Milk kit will be given at the birth visit and milk will be
collected at 1 month and mailed in or picked up; At the 6 month
visit a breast milk collection kit will be left with the mothers who
are still nursing, and the breast milk will be picked up with the
saliva after the visit.
80-100 mL
80-100 mL
Paternal
Blood
27.5 mL
(4 tubes)
27.5 mL
(4 tubes)
Urine
40
40
Hair (~20 strands)
X
X
Nails (clippings from all toes)
X
X
2nd Adult Caregiver in Home
Saliva (3 collections per day for 2 days)
X
Child
Heel Stick in conjunction with routine newborn heel
stick collection (a 5 spot and a 2 spot blood card)
X
Meconium (at least one sample from each child)
X
19 mL
(4 tubes)
Blood
Urine (amount from diaper will vary)
Hair (~20 strands)
Saliva (2 collections per day for 2 days)
X
X
X
X
Revised 8/27/08
Appendix C
Analytes in Biospecimen Collected for NCS--January 2008
Immediate Analysis
(performed on all samples collected)
Potential analytes to Address NCS Hypotheses
(analysis to be included in future case-control studies)
Hematocrit value to support potential future RBC folate
measure
Stress hormones (e.g. cortisol, corticotropin releasing hormone, ACTH)
Reproductive hormones (e.g. estriol, estradiol, progesterone)
Infection and inflammation indicators (e.g. cytokines, interleukins, multiple Ig types)
Glucose metabolism analytes (e.g. fasting blood glucose levels, insulin levels, HgbA1C)
Nutritional analytes (e.g. RBC folate, vitamins, omega 3 fatty acids, )
Metals (e.g. mercury, lead, cadmium)
Non-persistent Pesticides (e.g. metabolites of atrazine, organophosphorus pesticides, and pyrethroid insecticides)
Environmental phenols (e.g. bisphenol A and parabens)
Persistent Organic Chemicals (e.g. dioxins and furans)
Genetic Material to be collected (genomic and mitochondrial DNA, RNA, Peripheral blood mononuclear cells (PBMCs)
Self-administered pregnancy test after pre-pregnancy visit
Creatinine
Illicit drug panel and cotinine
Phytoestrogens
Phthalates
Perchlorate and iodide
Stress hormone (cortisol)
Infection indicators (PCR for Chlamydia/Gonnorhea)
Metals (e.g. mercury, arsenic)
Environmental phenols (e.g. bisphenol A)
Non-persistent Pesticides (e.g. metabolites of atrazine, organophosphorus pesticides, and pyrethroid insecticides)
pH at 3rd trimester clinic visit
Infection and inflammation indicators (bacterial vaginosis, antibodies, cytokines, metalloproteinase)
Hair
None
Cotinine
Total mercury
Nails
None
Metals (e.g. mercury, arsenic)
Saliva
None
Stress hormone (cortisol)
Size measurements, weight and photographs
Infection and inflammation indicators (e.g. cytokines, antibodies)
Chemical contaminants (to be determined)
Cord Blood
Hematocrit value to support potential future RBC folate
measure
Stress hormones (e.g. cortisol, corticotropin releasing hormone, ACTH)
Reproductive hormones (e.g. estriol, estradiol, progesterone)
Infection and inflammation indicators (e.g. cytokines, interleukins, multiple Ig types)
Glucose metabolism analytes (e.g. fasting blood glucose levels, insulin levels, HgbA1C)
Nutritional analytes (e.g. RBC folate, vitamins, omega 3 fatty acids, )
Metals (e.g. mercury, arsenic)
Non-persistent Pesticides (e.g. metabolites of atrazine, organophosphorus pesticides, and pyrethroid insecticides)
Environmental phenols (e.g. bisphenol A and parabens)
Persistent Organic Chemicals (e.g. dioxins and furans)
Genetic Material to be collected (genomic and mitochondrial DNA, RNA, Peripheral blood mononuclear cells (PBMCs)
Meconium
None
Cotinine
Organophosphate metabolites
Biospecimen
Blood
Urine
Vaginal Swabs
Placenta and Umbilical Cord
Breast Milk
None
C.3.3-2
Nutritional analytes (e.g. antioxidants, lipids, carbohydrates, endogenous compounds )
Phytoestrogens and other hormones
Perchlorate, iodide, thiocynate, nitrate
Metals (manganese and others)
Non-persistent Pesticides (e.g. metabolites of atrazine, organophosphorus pesticides, and pyrethroid insecticides)
Environmental phenols (e.g. bisphenol A and parabens)
Persistent Organic Chemicals (e.g. dioxins and furans)
Revised 8/27/08
Appendix C
C.3.4-1
DRAFT
NCS PROTOCOL SUMMARY OF ENVIRONMENTAL SAMPLES BY CONTACT (FOR THE SAME HOME)
DRAFT -- 8/15/2008
Pre- Pregnancy
Indoor Air
Pregnancy
P1 Home
Within X
days of
P1
T1 - 1st
(Home)
T1 - Prior
(Home)
**
**
X
PU
Birth
Days of T1,
T3 - First
T1-Prior,
Within X Birth Visit
(Home)
T3-First T3 (Clinic) Days of T3 (Hospital)
Post-natal
6 Month
Visit
(Home)
12 Month
Visit
(Home)
X, PU
X, PU
24 Months
(Phone)
Method
% Homes
PM2.5 - metals (XRF); total carbon (reflectance)
(filter to be archived after weighing)1
Pump
100
X
PU
VOCs (Note: 10% subsample in pilot)
Badge
10 (pilot)
X
PU
**
**
X
PU
X, PU
X, PU
Carbonyls (Aldehydes & Ketones)
Badge
100
**
**
X
PU
X5
Return
X, PU
X, PU
5
X , return
NO2 (Trigger: unvented flame source, e.g.,
cookstove, space heater, present, plus 2-3% without
source)
Badge
50
**
**
X
PU
X
5
Return
X, PU
X, PU
X , return
Badge
25
X, PU
X, PU
Allergens, endotoxin (to be archived)
Vacuum
100
X
X
X
X
X
Mold (to be archived)
Vacuum
Wipe
100
100
X
X
X
X
X
X
Plate
100
O3 (Trigger: source, e.g., electrostatic filter,
ozonator, laser printer present, plus 5% without
source)
House Dust
Inorganics/metals (wipe to be archived)
Deposition plate (method TBD, to be archived)
SVOCs (wipe to be archived)
Wipe
100
Pesticides: Pyrethroids (composite, store P1 wipes
for 3 mos to determine pregnancy)
Drinking Water
Wipe
100
Disinfection Byproducts (DBPs) - HAA9, THMs
Water
10%
VOCs (pilot)
Soil
Composited play area soil (to be archived)
Water
Soil
12 (pilot)
X 3,5
X
2
Visual Assessment - Indoor, outdoor 4
X
X 5, return
Return after
birth
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
100 (1 per
structure)
5
X
X 5, return
X
X
X
Notes:
X = Sample will be collected at contact. PU = Pick up sample (Pump and badge samples will be left in place for 6-7 days). C = Community sample.
1
May also do PM2.5 or PM2.5-10 if suitable indoor methods are identified.
2
Where private wells provide tap water.
3
Deploy plate at T3 contact (self collection) and mail back at 1-month.
4
Some observational data will be gathered by neighborhood drive arounds / extant data sources.
5
Self-collected samples - Activity is initiated at in-person visit or is mailed to the participant and requires participant action (e.g., collect and mail in badge). Time frame for completion varies and is specific to each activity.
** Substudy of air exposures including pesonal samples to be planned.
Community Outdoor Air - 9/17/07
Note: Each SC will likely be asked to submit a proposal for community outdoor air sampling, based onone of the three options listed under this table. The NCS PO is still deciding how best to handle outdoor sampling. The focus will be on supplementing
existing ambient air monitoring data (if not near enough to the segment). Implementation will depend on costs and how SC plans to utilize the data in air and/or exposure modeling efforts.
PM2.5 - Metals (XRF), total carbon (reflectance) (filter to be archived after weighing)
PM10 (filter to be archived after weighing)
NO2, NOx
SO2
O3
Options for supplemental community outdoor monitoring (SC will propose one, based on their communities and propsed modeling):
1) One set of sampling equipment (same as that used for indoor air) to be rotated among segments on a quarterly basis for ~1 week periods.
2) One ambient air monitoring station placed in PSU - hourly, continuos measures. This assumes that the equipment will be provided by NCS; placement, operation, maintenance, and calibration provided by the Study Center (will need to identify
qualified staff).
3) For LUR or other modeling - up to 3 NO2/NOx Ogawa badges taken in each segment simultaneously 2x/year (~2 weeks each), or one PM2.5 (and/or PM10) sampler in each segment (could be simultaneous or rotating)
Revised 8/27/08
Appendix C
C.3.5–1
NCS Physical Measures Collections
Contact Schedule Physcial Measures 7-22-08
Pre- Pregnancy
Physical Measures
Within X
Days of
P1 Home
P11
P
1 Month
(Phone)
P
2 Month
(Phone)
Pregnancy
P
4 Month
(Phone)
T1 - 1st
(Home)
Within X
T1 - Prior Days of
1
(Home)
T1
16 - 17
Weeks
(Phone)
T2
Birth
T3
(Clinic)
Within X
Days of 36 Weeks
1
(Phone)
T2/T3
Post-Natal
1 Month
B2
Within X
Visit if
B1
PreDelivery discharge weeks of Needed2
1
(Home)
(Hospital) (Hospital)
B2
6 Month Within X
12 Month
Days of 6 9 Months
3 Months
Visit
Visit
1
(Phone)
(Home) Mo. Visit (Phone) (Home)
Within X
Days of
12 Mo.
1
Visit
18 Mos.
(Phone)
24 Mos.
(Phone)
Within X
36 Month days of
36 Month
30 Mos.
Visit
1
(Phone) (Clinic)
Visit
Anthropometric Measures
Maternal Weight (2 measures)
X
X
X
X
Maternal Standing Height (2)
X
Maternal Sitting Height (2)
X
Maternal Mid Arm Circumference (2)
X
Maternal Hip Circumference (2)
X
Maternal Waist Circumference (2)
X
Maternal Head Circumference (2)
X
X
X
X
X
Maternal Triceps Fold (2)
X
X
X
X
Maternal Subscapular Skin Fold (2)
X
X
X
X
Paternal Weight (2)
X
X
Paternal Standing Height (2)
X
X
Paternal Sitting Height (2)
X
X
Paternal Mid Arm Circumference (2)
X
X
Paternal Hip Circumference (2)
X
X
Paternal Waist Circumference (2)
X
X
Paternal Head Circumfereence (2)
X
X
Paternal Triceps Fold (2)
X
X
Paternal Subscapular Skin Fold (2)
X
X
Infant Recumbant Length (2)
X
X
X
X
Child Height (2)
X
X
Infant/Child Weight (2)
X
X
X
X
X
X
X
X
X
X
Infant/Child Abdomen Circumference (2)
X
X
X
X
X
Infant/Child Thigh Circumference (2)
X
X
X
X
X
Infant/Child Triceps Skin Fold (2)
X
X
X
X
X
Infant/Child Subscapular Skin Fold (2)
X
X
X
X
X
X
X
Infant/Child Head Circumference (2)
Infant/Child Mid Upper Arm Circumference (2)
Blood Pressure
Maternal Blood Pressure
Paternal Blood Pressure
X
X
X
X
X
X
Infant/Child Blood Pressure
Maternal/Fetal Ultrasound
Crown rump length (2)
Gestational age
x
x
x
x
Cardiac activity
X
X
Presentation
X
X
Biparietal Diameter (BPD) (2)
X
X
Head circumference (HC) (2)
X
X
Abdominal circumference (AC) (2)
X
X
Leg measured: (for FL, MTC, MTLC, MTA, MTLMA)
X
X
Femur length (FL) (2)
X
X
Mid thigh circumference (MTC) (2)
X
X
Mid thigh lean mass circumference (MTLMC) (2)
X
X
Mid thigh total area (MTA) (calculated)
X
X
Mid thigh lean mass area (MTLMA) (2)
X
X
Abdominal wall thickness (AWT) (2)
X
X
Sex
X
X
For Multiple Fetuses (in addition to above measures)
X
X
Chorionicity
X
X
Amnionicity
X
X
Position of each fetus
X
X
Estimated fetal weight
X
X
Location of placenta
X
X
Membranes
X
X
Revised 7/22/08
Appendix C
C.3.5–2
NCS Physical Measures Collections
Contact Schedule Physcial Measures 7-22-08
Pre- Pregnancy
Physical Measures
Within X
Days of
P1 Home
P11
P
1 Month
(Phone)
P
2 Month
(Phone)
Pregnancy
P
4 Month
(Phone)
T1 - 1st
(Home)
Within X
T1 - Prior Days of
1
(Home)
T1
16 - 17
Weeks
(Phone)
T2
Birth
T3
(Clinic)
Within X
Days of 36 Weeks
1
(Phone)
T2/T3
Post-Natal
1 Month
B2
Within X
Visit if
B1
PreDelivery discharge weeks of Needed2
1
(Home)
(Hospital) (Hospital)
B2
6 Month Within X
12 Month
Days of 6 9 Months
3 Months
Visit
Visit
1
(Phone)
(Home) Mo. Visit (Phone) (Home)
Within X
Days of
12 Mo.
1
Visit
18 Mos.
(Phone)
24 Mos.
(Phone)
Within X
36 Month days of
36 Month
30 Mos.
Visit
1
(Phone) (Clinic)
Visit
Infant Neonatal Exam
2-D Images
X
X
Face-frontal
X
X
Face-profile (right)
X
X
Face-profile (left)
X
X
X
X
Anterior penis to anus (AGD1) (2)
X
X
Posterior base of penis to anus (AGD2) (2)
X
X
Posterior of scrotum/fourchette to anus (AGD3) (2)
X
X
Prenatal care
X
X
Prenatal labs
X
X
Ultrasound findings
X
X
Complications
X
X
Prenatal procedures
X
X
Admission information
X
X
Labor information
X
X
Delivery information
X
X
Analgesia received in labor
X
X
Medications
X
X
Delivery information
X
X
Post delivery information
X
X
Compilcation during hospitalization
X
X
Major congenital malformations
X
X
Medications during hospital stay
X
X
Oxygen/asssisted ventilation
X
X
Immunization
X
X
Circumcision
X
X
Screening Tests
X
X
Transfer information
X
X
Discahrge weight
X
X
Discharge information
X
X
Expired
X
X
Anogenital Distance Measures
Chart Abstraction - Prenatal, Labor, & Delivery
Chart Abstraction - Neonatal
Infant Physical Exam
2-D Face-frontal
X
X
2-D Face-profile right
X
X
2-D Face-profile left
X
X
X
X
X
Revised 7/22/08
Appendix C
C.3.6–1
Initial Pregnancy Screener Algorithm 6.30.08
Collect/ Confirm Age?*
R who previously reported herself pregnant at
Enumeration or Proxy interviews for a minor who
was reported pregnant at Enumeration.
Yes, Currently or
Probably Pregnant**
Due Date/ Date of
LMP/ Weeks
Pregnant/ Months
Pregnant/ Current
Trimester?
Currently Pregnant?*/
Probably Pregnant?
Age of Majority to Age 49 and No to
Currently or Probably Pregnant, or
RF/DK to Probably Pregnant
Pregnancy Status Miscoded and
Age of Majority through Age 49
Currently
Trying?
Number of
months
trying?
Yes, and due date between
first and last eligible due dates***
Pregnant Eligible
Group
(Consent for
Pregnancy Visit)
Yes, and under the Age of Majority or > 49 and
due date before first eligible due date (per
Yes, and Age of Majority to Age segment) OR under Age of Majority or >49 and
No Longer Pregnant**** OR all ages and due
49 and due date before first
eligible due date (per segment) date after last eligible due date (per segment)***
OR Pregnancy Status Miscoded and
OR No Longer Pregnant ***
Under Age of Majority or >49 OR RF/DK to
Current Trimester.
Holding Group
(Recontact 6
mos. after Due
Date)
No Follow up
Group
<5 months and Age
of Majority to Age 49
High Tryer Group
(Consent for
Preconception
Visit or
Followup Calls)*****
Yes
No or RF/ DK
Trying 5-11 months
Trying 12 or more
Yes, R surgically
and Age of Majority
months and Age of Majority
sterile or had menopause
to Age 34
to Age 49 OR trying 5-11 months
and age 35-49 OR RF/DK
Moderate
No Follow
Group
Up Group
Low
(Will receive
Group
call in 3
(Will call in
months)
6 months)
*Age and whether pregnant will be collected either during the Enumeration or the Pregnancy Screener depending on whether the household reporter is the same person as the Pregnancy
Screener respondent. Only women who are at the Age of Majority to Age 49 or pregnant proceed from the Enumeration to the Pregnancy Screener.
**If eligible female reports that she is probably pregnant, her pregnancy will be verified at the time that her T1 visit is scheduled.
***First and last eligible due dates are based on the dates that recruiting starts and ends in each segment. The last eligible due date for all segments in each PSU will be 5 years after the first
eligible due date of the segment which was opened last.
****Women under the Age of Majority or over 49 reported pregnant at Enumeration are not asked whether or not they are pregnant or probably pregnant at the Pregnancy Screener. If any of
these women are no longer pregnant (as reported either by self or by their parents when asked for the baby's due date), they will be assigned to the No Follow-up Group.
***** The algorithm will determine whether or not an eligible female is to be sub-sampled for the P1 visit. Initially, all participants in the High Non-Tryer and High Tryer Groups will receive the
follow up phone calls. When the P1 becomes available, those sub-sampled will receive the preconception consent vist while the rest will only receive the follow up phone calls.
The algorithm will create a flag variable to identify PPG statuses that are created from refused or don't know answers, called "PPGFlagIncompleteData". Special Situations: Regarding
pregnancy status, the flag variable will be "no" if the respondent answers probably pregnant but responds refused/don't know to whether pregnant. The flag will be "yes" if both are
refused/don't know. Regarding gestational age, the variable will be "no" if the respondent can provide due date, date of last menstrual period or weeks pregnant, but "yes" if the respondent
provides months pregnant or trimester pregnant.
All women who fall into the Pregnant Eligible and High Tryer and High Non-Tryer groups are asked about their plans to move at the time the T1 or P1 visit is scheduled. If a woman responds
that she is moving (before her baby is born or within 2 months if in the High Tryer or High Non-Tryer group) and provides a new address the supervisor will review her case before
determining to schedule a T1 or P1 visit (for sub-sampled women) or determine her ineligible.
The algorithm will calculate PPG at the initial Pregnancy Screener based on the respondent's current age. At subsequent calls, the algorithm will calculate whether those that are 49 would be
50 at the next scheduled follow up phone call. If the woman has received a P1 visit, she will be allowed to continue through the P4 call, even though she has turned 50. Otherwise, if the
respondent will be 50 at the next contact, she will instead be assigned to the No Follow Up group.
R surgically
sterile or had
menopause?
No or RF/DK, and
Age 45-49
No or RF/DK, and Age of
Majority to Age 44
Low Group
(Will call in 6
months)
Sex with male
in past 3
months?
No, and 35-44 or RF/DK
Moderate
Group
(Will receive
call in 3 months)
Using method other
than withdrawal or natural
family planning and 30-44
OR RF/ DK
Low Group
(Will call in 6
months)
Yes
No or RF/ DK
Partner had a
vasectomy?
Low Group
(Will call in 6 months)
No, Not Sure or RF
Yes
Doing anything
to prevent
pregnancy?
Low Group
(Will call in 6 monhts)
Yes
Contraceptive
type?
No, and Age of Majority to Age 34
High Non-Tryer Group
(Consent for
Preconception Visit or
Followup Calls)*****
Using withdrawal or
Using method other than
natural family planning
withdrawal or natural family
and Age of Majority to
planning and Age of Majority to
Age 34
Age 29 OR using withdrawal or
natural family planning and 35-44
Moderate Group
(Will receive call
in 3 months)
High Non-Tryer Group
(Consent for
Preconception Visit or
Followup Calls)*****
Revised 6/30/08
Appendix C
C.3.6–2
Follow Up Algorithm: P1, P2 and P4 Month Calls - 6.30.08
High Non-Tryer Group 1 No Contraception
(Women not trying and
not using contraception
Age of Majority to Age 34)
High Tryer Group - Trying to Become Pregnant
(Women trying to become pregnant, Age of
Majority to Age 49 and trying 4 or less months)
Intro to P1/P2/P4 Month: I'm calling today to
update some information I have for you.
Learned
Pregnant?
Yes
Pregnant Eligible
Group
(Consent for
Pregnancy Visit)
You have been chosen
to be part of this
important study
because of your due
date. The next step for
the group you're in is a
home visit. I would like
to tell you more about it
and give you all the
information you need to
decide if you would like
to be part of the study.
Are you now trying to
become pregnant?
Yes, Trying
No, or RF/DK
No, Not Trying or RF/DK
Doing anything
to prevent
pregnancy?
Currently Pregnant
Due date/ First day of last menstrual
period/ Weeks pregnant?
(Computer to assume woman half way
through her pregnancy if RF/DK for all
questions)
Eligible Due Date
Intro to P1/P2/P4 Month: I'm calling today
to update some information I have for
you. Last time we spoke, you weren't
trying to become pregnant, but we know
that plans can sometimes change.
High Non-Tryer Group 2 High Failure Rate Contraception
(Women not trying and using
contraception with high failure rate Age
of Majority to Age 34)
Still
Trying?
Due date before first
eligible due date
OR Pregnancy Loss
and Age of Majority
to 49.
Due date after last
eligible due date OR
Pregnancy Loss
and >49.
Holding Group
(Recontact
6 mos. after
Due Date)
No Followup
Group
You are too far along in
your pregnancy to be
part of this study now,
but we will get in touch
with you about six
months after your baby
is born to update your
information. If you
become pregnant
again, you may be able
to be part of the study
Thanks for your time.
High Tryer Group
(Continue calls through P4 - then move to
Moderate Group)
We'll call to check in with you and update your
information in another month or two.
Yes, and trying
4 months or less
(calculated from
start of P1
Month call)
High Tryer Group
(Continue calls through
P4 - then move to
Moderate Group)
No, or Yes and
trying more than
4 months (calculated
from start of P1 Month
call), or RF/DK
Due date/ First day of
last menstrual period/
Weeks pregnant?
(Computer to assume
woman half way
through her
pregnancy if RF/DK
for all questions)
Eligible Due Date
Ineligible Due Date
Pregnant
Eligible Group
(Consent for
Pregnancy
Visit)
Holding Group
(Recontact
6 mos. after
Due Date)
Moderate Group
(Call in 3 months)***
We'll call to check in
with you and update
your information in
another month or
two.
Yes, trying
or RF/DK
We'll call to
check in with
you and update
your information
in another
month or two.
No, not
trying
We understand that plans can
change and that you're not
trying to become pregnant
right now. We'll call to check
in with you and update your
information in another month
or two.
You have been
chosen to be part of
this important study
because of your due
date. The next step
for the group you're
in is a home visit. I
would like to tell you
more about it and
give you all the
information you
need to decide if you
would like to be part
of the study
You are too far along in
your pregnancy to be
part of this study now,
but we will get in touch
with you about six
months after your baby
is born to update your
information. If you
become pregnant
again, you may be able
to be part of the study
Thanks for your time.
No, and 35-44
or RF/DK
Moderate Group
(Will receive call in 3
months)***
Low Group
(Will call in 6
months)
We'll call to check in with you and
update your information in about six
months.
High Non-Tryer Group
(Continue calls
through P4 - then move
to Moderate Group)
Contraceptive
type?
We'll call to check in with you and
update your information in another
month or two.
Using method other than
withdrawal and natural
family planning and age
30-44 OR RF/DK
No, and Age of Majority
to Age 34
Yes
We'll call to check in with you and
update your information in another
month or two.
Using method other than
withdrawal and natural family
planning and Age of Majority to
Age 29 OR using withdrawal or
natural family planning and 35-44
Moderate Group
(Will receive call
in 3 months)***
We'll call to check in with you and
update your information in another
month or two.
Using withdrawal or natural family
planning and Age of Majority to Age 34
High Non-Tryer Group
(Continue calls through P4 then move to Moderate
Group)
We'll call to check in with you and
update your information in another
month or two.
*All women who fall into the Pregnant Eligible Group will be asked about their plans to move at the time the T1 visit is scheduled.
**First and last eligible due dates are based on the dates that screening starts and ends in each segment. The last eligibile due date for all segments in each PSU will be 5 years after the first eligible due date of the segment which was opened last.
***The respondent can spend up to a total of four months in the High Tryer and High Non-Tryer PPGs before being assigned to the Moderate PPG and up to a total of nine months in the Moderate PPG before being assigned to the Low PPG.
The algorithm will determine whether an eligible female is to be sub-sampled for the P1 visit or not. Initially, all participants in the High Non-Tryer and High Tryer Groups will receive the follow up phone calls. When the P1 becomes available, those sub-sampled will receive the
preconception consent vist while the rest will only receive the follow up phone calls.
The algorithm will create a flag variable to identify PPG statuses that are created from refused or don't know answers, called "PPGFlagIncompleteData". Special Situations: Regarding pregnancy status, the flag variable will be "no" if the respondent answers probably pregnant but
responds refused/don't know to whether pregnant. The flag will be "yes" if both are refused/don't know. Regarding gestational age, the variable will be "no" if the respondent can provide due date, date of last menstrual period or weeks pregnant, but "yes" if the respondent provides
months pregnant or trimester pregnant.
The algorithm will calculate PPG based on the respondent's current age. For those that are 49, if they have had a P1 they will be allowed to continue through the P4 phone call, even if they have reached age 50. For those that would fall into the Moderate, Low or Holding Group,
however,if the algorithm calculates the respondent would be 50 at the next scheduled follow up phone call, they will instead be assigned to the No Follow Up group.
Revised 6/30/08
Appendix C
C.3.6–3
Moderate Pregnancy Probability Group Call 6.30.08
Previously reported NOT trying to get pregnant (not
doing anything to prevent pregnancy and age 35-44 OR
using method other than withdrawal or natural family
planning and Age of Majority through age 29 OR using
withdrawal or natural family planning and 35-44)
Previously reported trying to get pregnant (trying
5-11 months and Age of Majority through age 34 or
trying more than 4 months from High PPG)
Pregnant?
No and
DK/RF
Still trying?
Has R had
three
Moderate
PPG calls?
No
Moderate
Group*
Yes
Low
Group*
Yes or Probably
Pregnant**
Recently lost
pregnancy, Age of Majority
Recently lost
through age 49
pregnancy, Age of
Due Date/ Date
and 9 months or less
Majority through
of LMP/ Weeks
remaining before last
age 49 and more than
Pregnant?
eligible due date
9 months before
OR recently lost
last eligible due date.
pregnancy and >49 OR
due date after last eligible
due date.
Holding
Group
Eligible
(Recontact
R's due date is after last
No Follow
due date***
in 6 mos.)
eligible due date
up Group
(R will not deliver before
last eligible due date)***
Pregnant Eligible
Group
(Consent for
No Follow
Pregnancy Visit)
up Group
Are you now
trying to become
pregnant?
Currently Pregnant
Not trying to become
pregnant
Trying to become
pregnant
Sex with male
last 3 months?
Has R had four
months in High
(Tryer and
Non-Tryer) PPG
calls?
No
High Tryer
Group*
No
Yes
Low Group
Doing anything
to prevent
pregnancy?
Yes
Moderate or
Next
Appropriate
Group*
*The Moderate Phone Call algorithm requires the incorporation of data on how long the respondent has spent in each PPG. The respondent can spend up to a total of four months in the High Tryer and
High Non-Tryer PPGs before being assigned to the Moderate PPG and up to a total of nine months in the Moderate PPG before being assigned to the Low PPG. The respondent can spend up to the
entire recruitment period in the Low group, which receives phone calls once every six months. The respondent can also move back up to the Moderate PPG and between the Moderate PPG and Low
PPG groups based on the combination of their questionnaire answers and PPG history. The amount of time allowed in the High Tryer and High Non-Tryer PPGs resets after the birth of a new baby or
the loss of a pregnancy.
**If eligible female reports that she is probably pregnant, her pregnancy will be verified at the time that her T1 visit is scheduled.
***First and last eligible due dates are based on the dates that screening starts and ends in each segment. The last eligible due date for all segments in each PSU will be 5 years after the first eligible
due date of the segment which was opened last.
The algorithm will create a flag variable to identify PPG statuses that are created from refused or don't know answers, called "PPGFlagIncompleteData". Special Situations: Regarding pregnancy
status, the flag variable will be "no" if the respondent answers probably pregnant but responds refused/don't know to whether pregnant. The flag will be "yes" if both are refused/don't know. Regarding
gestational age, the variable will be "no" if the respondent can provide due date, date of last menstrual period or weeks pregnant, but "yes" if the respondent provides months pregnant or trimester
pregnant.
The algorithm will determine whether or not an eligible female assigned to the High Tryer and High Non-Tryer groups for the first time is to be sub-sampled for the P1 visit. Initially, all participants in the
High Non-Tryer and High Tryer Groups will receive only the follow up phone calls. When the P1 becomes available, if sub-sampling is done, those who are sub-sampled will receive the preconception
consent and vist while the rest will only receive the follow up phone calls.
All women who fall into the Pregnant Eligible and HighTryer and High Non-Tryer groups will be asked about their plans to move at the time the T1 or P1 visit is scheduled. If a woman responds that she
is moving (before her baby is born or within 2 months if in High Tryer and Non-Tryer groups) and provides a new address the supervisor will review her case before determining to schedule a T1 or P1
visit or determine her ineligible.
Women who move between the High Tryer, High Non-Tryer and any other group will be given a P1 only once per year.
At the end of the recruitment period, all respondents who are not pregnant will be assigned to the No Follow Up Group. They will be informed that recruitment is ending and that they will not be
contacted again about new pregnancies (they may be contacted about children already enrolled).
Age of Majority through age 34
and No or RF/DK
Yes
Age 35-44 and
No or RF/DK
Has R had
three
Moderate
PPG calls?
Has R had four
months in High
(Tryer and
Non-Tryer) PPG
calls?
No
No
Yes
Moderate
Group*
Contraceptive
type?
Yes
Low Group*
High
Non-Tryer
Group*
Moderate or
Next Appropriate
Group*
Using method other
than withdrawal or natural
family planning and Age of
Majority through age 29 OR
using withdrawal or natural
family planning and 35-44
Using method other
Using withdrawal or
than withdrawal or natural
natural family planning
family planning and 30-44
and Age of Majority
OR RF/ DK
through age 34
Moderate or
Next
Appropriate
High
Group*
Non-Tryer /
Next
Low Group*
Appropriate
Group*
The algorithm will calculate PPG based on the respondent's current age. For those that are 49, if they have had a P1 they will be allowed to continue through the P4 phone call, even if they have
reached age 50. For those that would fall into the Moderate, Low or Holding Group, however,if the algorithm calculates the respondent would be 50 at the next scheduled follow up phone call, they will
instead be assigned to the No Follow Up group.
Revised 6/30/08
Appendix C
C.3.6–4
Low Call Algorithm 06.30.08
Introduction for All Calls:
I'm calling to update some information we have for you. A lot can change in six months, so I may ask
you questions that we've previously asked. These questions will help us to see if you can take part in
the Study. Answering them does not mean that you agree to be part of the Study. The National
Children's Study is enrolling women of child-bearing age to get information about pregnancy. Because
we are interested in pregnancy, it is important for us to know if you are currently pregnant.
Are you currently
pregnant?
Yes, currently pregnant
No, not currently pregnant
Don't know/Refused
Yes, Probably Pregnant**
Do you think you are
probably pregnant or not?
Currently
Trying?
Due Date/ Date of
LMP/ Weeks
Pregnant/ Months
Pregnant/ Current
Trimester?
Due date between first
and last eligible due dates***
Pregnant Eligible Group
(Consent for
Pregnancy Visit)
No, probably not pregnant
Number of
months
trying?
Due date after last eligible
due date OR RF/DK to
Current Trimester***
No Follow up
Group
<5 months
and age of majroity
through 49
High Tryer Group/
Next Appropriate
Group*
Trying 5-11 months
and age of majority
through 34
Moderate
Group*
(Will receive
call in 3
months)
Yes
Trying 12 or more
months and age of majority
through 49 OR trying 5-11
months and age 35-49
OR RF/DK
Low
Group
(Will call in
6 months)
R surgically
sterile or had
menopause?
No, or RF/DK
Yes, R surgically
sterile or had menopause
No, and Age 45-49
No Follow
Up Group
Low Group
(Will call in 6
months)
*The Low Phone Call algorithm requires the incorporation of data on how long the respondent has spent in each PPG. The respondent can spend up to a total of four months in the High Tryer
and Non-Tryer PPG before being assigned to the Moderate PPG and up to a total of nine months in the Moderate PPG before being assigned to the Low PPG. The respondent can spend up to
the entire recruitment period in the Low group, which receives phone calls once every six months. The respondent can also move back up to the Moderate PPG and between the Moderate PPG
and Low PPG groups based on the combination of their questionnaire answers and PPG history. The amount of time allowed in the High Tryer and Non-Tryer PPGs resets after the birth of a
new baby or the loss of a pregnancy.
**If eligible female reports that she is probably pregnant, her pregnancy will be verified at the time that her T1 visit is scheduled.
***First and last eligible due dates are based on the dates that recruiting starts and ends in each segment. The last eligible due date for all segments in each PSU will be 5 years after the first
eligible due date of the segment that was opened last.
The algorithm will create a flag variable to identify PPG statuses that are created from refused or don't know answers, called "PPGFlagIncompleteData". Special Situations: Regarding pregnancy
status, the flag variable will be "no" if the respondent answers probably pregnant but responds refused/don't know to whether pregnant. The flag will be "yes" if both are refused/don't know.
Regarding gestational age, the variable will be "no" if the respondent can provide due date, date of last menstrual period or weeks pregnant, but "yes" if the respondent provides months pregnant
or trimester pregnant.
The algorithm will determine whether or not an eligible female assigned to the High Tryer and High Non-Tryer groups for the first time is to be sub-sampled for the P1 visit. Initially, all participants
in the High Non-Tryer and High Tryer Groups will receive only the follow up phone calls. When the P1 becomes available, if sub-sampling is done, those who are sub-sampled will receive the
preconception consent and vist while the rest will only receive the follow up phone calls. Women who move between the High Tryer, High Non-Tryer and any other group will be given a P1 only
once per year.
All women who fall into the Pregnant Eligible, High Tryer and High Non-Tryer groups are asked about their plans to move at the time the T1 or P1 visit is scheduled. If a woman responds that
she is moving (before her baby is born or within 2 months if in High Tryer or High Non-Tryer group) and provides a new address the supervisor will review her case before determining to
schedule a T1 or P1 visit or determine her ineligible.
At the end of the recruitment period, all respondents who are not pregnant will be assigned to the No Follow Up Group. They will be informed that recruitment is ending and that they will not be
contacted again about new pregnancies (they may be contacted about children already enrolled).
The algorithm will calculate PPG based on the respondent's current age. For those that are 49, if they have had a P1 they will be allowed to continue through the P4 phone call, even if they have
reached age 50. For those that would fall into the Moderate, Low or Holding Group, however,if the algorithm calculates the respondent would be 50 at the next scheduled follow up phone call,
they will instead be assigned to the No Follow Up group.
No, and 35-44 or RF/DK
Moderate
Group*
(Will receive
call in 3 months)
No, and Age of majority
through 44 OR RF/DK
Sex with male
in past 3
months?
Yes
No or RF/ DK
Partner had a
vasectomy?
Low Group
(Will call in 6 months)
No, Not Sure or RF
Yes
Doing anything
to prevent
pregnancy?
Low Group
(Will call in 6 monhts)
Yes
Contraceptive
type?
No, and age of
majority through 34
High Non-Tryer
Group/ Next
Appropriate
Group*
Using method other
than withdrawal or
natural family
planning and 30-44
OR RF/ DK
Using method other
than withdrawal or natural
family planning and age of majority
through 29 OR using withdrawal or
natural family planning and 35-44
Using withdrawal or
natural family planning
and 18-34
Low Group
(Will call in 6
months)
Moderate
Group*
(Will receive call
in 3 months)
High Non-Tryer
Group/ Next
Appropriate
Group*
Revised 6/30/08
Appendix C.4
Deleted
Appendix C.5
Outside Groups Consulted
Appendix C
C.5.1–1
Federal Advisory Committee
The National Children’s Study Federal Advisory Committee, constituted under the
Federal Advisory Committee Act, provides advice and recommendations to the Director
of the National Children’s Study, the Director of the National Institute of Child Health
and Human Development, and the Interagency Coordinating Committee regarding critical
aspects of the Study.
There are currently three designated National Children’s Study Advisory Committee
subcommittees: Scientific Review, Ethics, and Community Engagement.
The National Children’s Study Federal Advisory Committee meets approximately three
times a year. These meetings are open to the scientific community and the general public.
Roster of Members
Alan R. Fleischman, MD (Chair)
Senior Vice President and Medical Director
March of Dimes
Jessica N. Sapienza, MHS (Executive Secretary)
Adjunct Studies Program Analyst, National Children’s Study
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health, HHS
Paul A. Seda (Committee Liaison Officer)
Invoicing Specialist, National Children’s Study
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health, HHS
Wilma Brakefield-Caldwell, RN
Public Health Nurse Administrator
John L. Butenhoff, PhD, CIH, DABT
Medical Department
3M Company
Maria Cancian, PhD
Institute for Research on Poverty
University of Wisconsin-Madison
Robert E. Chapin, PhD
Investigative Developmental Toxicology Lab
Pfizer Global Manufacturing Plant
Revised 5/12/08
Appendix C
C.5.1–2
José F. Cordero, MD, MPH
Graduate of Public Health
University of Puerto Rico
Janet Currie, PhD
Department of Economics
Columbia University
Ana V. Diez-Roux, MD, PhD, MPH
Center for Social Epidemiology and Population Health
University of Michigan
Nancy Neveloff Dubler, LLC
Department of Epidemiology and Population Health
Albert Einstein College of Medicine of Yeshiva University
Helen DuPlessis, MD, MPH
Center for Healthier Children, Families, and Communities
University of California, Los Angeles
Elena Gates, MD
Department of Clinical Obstetrics, Gynecology, and Reproductive Sciences
University of California, San Francisco
Myron Genel, MD
Professor Emeritus of Pediatrics
Yale University School of Medicine
Richard Guzman, MSW, MPH
Community Health and Social Services Center
Carol J. Henry, PhD, DABT
Advisor and Consultant
James N. Jarvis, MD
Department of Pediatrics
University of Oklahoma Health Sciences Center
Michael Lebowitz, PhD
Retired Professor of Medicine and Epidemiology-Biostatistics
University of Arizona
Liliana J. Lengua, PhD
Department of Psychology
University of Washington
Revised 5/12/08
Appendix C
C.5.1–3
Bruce Levin, PhD
Department of Biostatistics
Columbia University Mailman School of Public Health
Jeffrey Long, PhD
Department of Human Genetics
University of Michigan School of Medicine
Gary Q. Peck, MD, FAAP
General Pediatric/Adolescent Medicine Physician
Amelie G. Ramirez, DrPH
Department of Epidemiology and Biostatistics
University of Texas Health Science Center at San Antonio
E. Albert Reece, MD, PhD, MBA
School of Medicine
University of Maryland
R. Gary Rozier, DDS, MPH
Department of Health Policy and Administration
University of North Carolina, Chapel Hill School of Public Health
David J. Schonfeld, MD
Division of Developmental Disabilities
Cincinnati Children’s Hospital Medical Center
Peggy M. Shepard
West Harlem Environmental Action, Inc. (WE ACT)
Benjamin S. Wilfond, MD
Department of Pediatrics
University of Washington School of Medicine
Alan M. Zaslavsky, PhD
Department of Health Care Policy
Harvard University Medical School
Duane F. Alexander, MD (ex officio member)
Director
Eunice Kennedy Shriver National Institute of Child Health and Human Development
National Institutes of Health, HHS
Revised 5/12/08
Appendix C
C.5.1–4
Allen Dearry, PhD (ex officio member)
Associate Director, Research Coordination, Planning, and Translation
National Institute of Environmental Health Sciences
National Institutes of Health, HHS
Kevin Y. Teichman, PhD (ex officio member)
Acting Deputy Assistant Administrator for Science
Office of Research and Development
U.S. Environmental Protection Agency
Edwin Trevathan, MD, MPH, FAAP (ex officio member)
Director
National Center on Birth Defects and Developmental Disabilities
Centers for Disease Control and Prevention, HHS
Page updated - 05/12/08
Revised 5/12/08
Appendix C
C.5.2–1
Interagency Coordinating Committee
The Interagency Coordinating Committee organizes and directs operations of the Study.
This committee is made up of staff from two federal agencies: the U.S. Department of
Health and Human Services (HHS) and the U.S. Environmental Protection Agency (EPA).
Within HHS, staff is contributed from the Centers for Disease Control and Prevention
(CDC) and the National Institutes of Health (NIH). CDC contributes staff from the National
Center on Birth Defects and Developmental Disabilities and the National Center for Health
Statistics; NIH contributes staff from the Eunice Kennedy Shriver National Institute of
Child Health and Human Development and the National Institute of Environmental Health
Sciences. EPA contributes staff from the National Center for Environmental Research, the
National Health and Environmental Effects Research Laboratory, the Office of Children's
Health Protection, and the National Exposure Research Laboratory.
Interagency Coordinating Committee Members
Elizabeth H. Blackburn, BSN (Chair)
Office of Children’s Health Protection, EPA
Amy Branum, MSPH
National Center for Health Statistics, CDC, HHS
Adolfo Correa, MD, PhD
National Center on Birth Defects and Developmental Disabilities, CDC, HHS
Sally Perreault Darney, PhD
National Health and Environmental Effects Laboratory, EPA
Nigel A. Fields, MSPH
National Center for Environmental Research, EPA
Kimberly Gray, PhD
NIEHS, NIH, HHS
Ron Iannotti, PhD
NICHD, NIH, HHS
Sarah Keim, MA, MS
NICHD, NIH, HHS
Sheila A. Newton, MS, PhD
NIEHS, NIH, HHS
James J. Quackenboss, MS
National Exposure Research Laboratory, EPA
Revised 5/12/08
Appendix C
C.5.2–2
Peter C. Scheidt, MD, MPH
NICHD, NIH, HHS
Kenneth Schoendorf, MD, MPH
National Center for Health Statistics, CDC, HHS
Marshalyn Yeargin-Allsopp, MD
National Center on Birth Defects and Developmental Disabilities, CDC, HHS
Page updated - 05/12/08
Revised 5/12/08
Appendix C
C.5.3–1
Steering Committee
The Steering Committee provides first level scientific direction to the National Children’s
Study. It is the arbiter of issues referred to it by the Program Office, the Study Principal
Investigators, and the Executive Steering Committee. It is empowered to make protocol
modifications that do not change the direction or cost of the Study, subject to
confirmation by the Program Office. The Steering Committee may refer management and
operational issues to the Executive Steering Committee. The Director of the Program
Office serves as the Chair of the Steering Committee.
The Steering Committee is currently comprised of 58 members. Each Study Center
(including the Vanguard Centers) has 2 representatives and 1 vote per Center. The
Coordinating Center has 3 members, one of whom has a vote. Each of the following
members has one vote: 2 members from the Interagency Coordinating Committee, 3
members from the Program Office, and 2 community and participant representatives.
There are a total of 32 votes. The Steering Committee structure and decision making
process may be revised and restructured when additional Study Centers are awarded and
added to the Steering Committee.
The full Steering Committee meets face-to-face at least once a year. Interim meetings by
conference call or video conferencing are scheduled as needed. Business of the Steering
Committee is considered closed except to the committee members and approved
observers.
National Children’s Study Steering Committee Members
Omar Abdul-Rahman, MD* Department of Preventive Medicine, University of
Mississippi
Robert Annett, PhD Department of
Pediatrics, University of New Mexico
Dean Baker, MD, MPH Department of
Medicine, University of California, Irvine
Kathleen Belanger, PhD Department of Epidemiology and Public
Health, Yale University School of Medicine
Shirley Beresford, PhD* Department of
Epidemiology, University of Washington
Michael Bracken, PhD, MPH Department of Epidemiology and Public
Health, Yale University School of Medicine
Revised 5/14/08
Appendix C
C.5.3–2
Ruth Brenner, MD, MPH National Children’s Study
Program Office, NICHD, NIH, HHS
Stephen Buka, ScD Department of
Community Health, Brown University
Thomas Burbacher, PhD* Department of Environmental and Occupational
Health Services, University of Washington
Laura Caulfield, PhD Center for Human Nutrition, Johns Hopkins University
Bloomberg School of Public Health
Edward B. Clark, MD Department
of Pediatrics, University of Utah
Leslie Cottrell, PhD Department of
Pediatrics, West Virginia University
Christine Cronk, ScD Department of Pediatrics,
Medical College of Wisconsin
Jennifer Culhane, PhD, MPH Department of Obstetrics and
Gynecology, Children’s Hospital of Philadelphia
Sally Davis, PhD Department of Pediatrics,
University of New Mexico
Nancy Dole, PhD Carolina Population Center, University
of North Carolina, Chapel Hill
Donald Dudley, MD Department of Obstetrics and Gynecology, University of Texas
Health Science Center at San Antonio
Maureen Durkin, PhD, DrPH Department of Population
Health Sciences, University of Wisconsin
Elaine Eaker, ScD
Westat
Jonas H. Ellenberg, PhD
University of
Pennsylvania/Westat
Barbara Entwisle, PhD Carolina Population Center, University of North Carolina, Chapel
Hill
Revised 5/14/08
Appendix C
C.5.3–3
Elaine Faustman, PhD Department of Environmental and Occupational Health Sciences,
University of Washington
Marianne Felice, MD Department of Pediatrics, University of Massachusetts
Sean Firth, PhD, MPH Department of Pediatrics, University of Utah Health Sciences
Center
Louise Flick, DrPH, MPE Department of Community Health, St. Louis University
School of Public Health
Alexa Fraser, PhD
Westat
Lynn Goldman, MD, MPH Department of Environmental Health Sciences, Johns
Hopkins University Bloomberg School of Public Health
William Grobman, MD Department of Maternal-Fetal Medicine, Northwestern
University
Daniel Hale, MD Department of Pediatrics, University of Texas Health Science Center at
San Antonio
Neal Halfon, MD, MPH Center for Healthier Children, Families, and Communities,
University of California, Los Angeles
Wendy Hellerstedt, MD, MPH Department of Epidemiology and Community Health,
University of Minnesota
Irva Hertz-Picciotto, PhD Department of Epidemiology and Preventive Medicine,
University of California, Davis
Calvin Hobel, MD Department of Obstetrics and Gynecology, University of California,
Los Angeles
Carol Hogue, Ph.D., MPH Women's and Children's Center, Emory University Rollins
School of Public Health
Jane Holl, MD, MPH Department of Pediatrics, Northwestern University
Sarah Knox, PhD National Children’s Study Program Office, NICHD, NIH, HHS
Philip Landrigan, MD Department of Community and Preventive Medicine, Mount Sinai
School of Medicine
Revised 5/14/08
Appendix C
C.5.3–4
Bruce Lanphear, MD, MPH Children’s Environmental Health Center, Cincinnati
Children’s Hospital Medical Center
Terry Leet, PhD Department of Epidemiology, St. Louis University School of Public
Health
Anthony Mawson, DrPH Department of Preventive Medicine, University of Mississippi
Patricia McGovern, PhD, MPH Department of Environmental Health Sciences,
University of Minnesota
Thomas McLaughlin, MDiv, ScD Department of Pediatrics, University of Massachusetts
Lynnae Millar-Sauvage, MD Department of Obstetrics, Gynecology, and Women's
Health, University of Hawaii at Manoa
Roberta Ness, MD, MPH Department of Epidemiology, University of Pittsburgh
Nigel Paneth, MD, MPH Department of Epidemiology, Michigan State University
Maureen Phipps, MD, MPH Department of Obstetrics and Gynecology, Brown
University
James J. Quackenboss, MS National Exposure Research Laboratory, EPA
Beatriz Rodriguez, MD, PhD, MPH Department of Epidemiology, University of Hawaii
at Manoa
Peter Scheidt, MD, MPH National Children’s Study Program Office, NICHD, NIH, HHS
Kenneth Schoendorf, MD, MPH National Center for Health Statistics, CDC, HHS
Stacy Scott In Black Print, Inc.
Robert Sokol, MD Department of Obstetrics and Gynecology,
Wayne State University
Bonny Specker, PhD Ethel Austin Martin Program in Human Nutrition, South
Dakota State University
Barbara Stoll, MD Department of Pediatrics, Emory University
School of Medicine
James Swanson, PhD Child Development Center, University of California, Irvine
Richard Sweet, MD Department of Obstetrics and Gynecology, University of California,
Davis
Revised 5/14/08
Appendix C
C.5.3–5
Leo Trasande, MD, MPP Department of Community and Preventive Medicine, Mount
Sinai School of Medicine
Robin Wilkerson, RN-C, PhD* Department of Women's and Children's Health,
University of Mississippi School of Nursing *Rotating Member
Updated May 2008
Revised 5/14/08
Appendix C
C.5.4 –1
Other Study Supporters
Study Supporters
The following organizations have expressed their support for the National Children’s Study:
Allergy and Asthma Networks Mothers of Asthmatics
Alpha Kappa Alpha Sorority, Inc.
Ambulatory Pediatric Association
American Academy of Pediatrics
American Academy of Sleep Medicine
American Association for Clinical Chemistry
American Association on Intellectual and Developmental Disabilities
American Chemistry Council
American College of Obstetricians & Gynecologists
American Educational Research Association
American Pediatric Society
American Psychological Association
American Public Health Association
American Society for Bone and Mineral Research
American Society for Pediatric Nephrology
American Speech-Language-Hearing Association
Association of American Medical Colleges
Association of Medical School Pediatric Chairs
Association of University Centers on Disabilities
Association of Women’s Health, Obstetric and Neonatal Nurses
Catholic Health Initiatives
Children’s Environmental Health Network
Coalition of Heritable Disorders of Connective Tissue
Center for Children’s Health and the Environment, Mount Sinai School of Medicine
Consortium of Social Science Associations
Cooley’s Anemia Foundation
Easter Seals
First Candle/SIDS Alliance
Genetic Alliance
Jeffrey Modell Foundation
Learning Disabilities Association of America
March of Dimes
National Association of Boards, Commissions and Councils of Catholic Education of the
National Catholic Educational Association
National Association of Counties
National Association of County and City Health Officials
National Association of Pediatric Nurse Practitioners
National Black Child Development Institute
National Catholic Rural Life Conference
National Center for Learning Disabilities
National Coalition of 100 Black Women
National Council of Catholic Women
National Education Association
National Family Planning and Reproductive Health Association
National Healthy Mothers, Healthy Babies Coalition
HU
UH
HU
UH
HU
UH
UH
HU
UH
HU
UH
HU
UH
HU
UH
HU
UH
HU
UH
HU
UH
UH
HU
UH
HU
UH
HU
UH
HU
UH
HU
UH
Appendix C
C.5.4 –2
National Hispanic Medical Association
National Medical Association
National Parent Teacher Association
National Rural Health Association
Safe Kids Worldwide
Osteogenesis Imperfecta Foundation
Population Association of America
PXE International
Society for Maternal Fetal Medicine
Society for Pediatric Nephrology
Society for Pediatric Research
Society for Research in Child Development
Society for the Study of Reproduction
Spina Bifida Association of America
The Arc of the United States
The Catholic Health Association of the United States
The Teratology Society
United Cerebral Palsy
United States Conference of Catholic Bishops
HU
UH
HU
UH
HU
UH
HU
UH
HU
UH
Page updated - 04/06/07
Appendix C
C.5.5–1
Executive Steering Committee
The Executive Steering Committee is a subset of the full Steering Committee. The
Executive Steering Committee carries out the majority of the protocol and operational
decision making, referring only those items necessary for full Steering Committee
consideration. This committee addresses issues that are budget neutral and topics that do
not change the Study’s mission.
Voting membership consists of the Principal Investigators from 7 Study Centers; 3
members from the Program Office including the National Children’s Study Director, who
is the Chair of the Committee; 2 members from the Interagency Coordinating Center; 2
Community/Participant Representatives; and the Principal Investigator for the
Coordinating Center. The Co-Principal Investigator for the Coordinating Center will
participate on the committee as a non-voting member.
Meetings are held monthly via conference call and face-to-face meetings are scheduled
every 2–3 months.
Executive Steering Committee Members
Ruth Brenner, MD, MPH National Children’s Study Program Office, NICHD, NIH, HHS
Stephen Buka, ScD Department of Community Health, Brown University
Edward B. Clark, MD Department of Pediatrics, University of Utah
Elaine Eaker, ScD
Westat
Barbara Entwisle, PhD Carolina Population Center, University of North Carolina, Chapel
Hill
Elaine Faustman, PhD Department of Environmental and Occupational Health Sciences,
University of Washington
Alexa Fraser, PhD
Westat
Sarah Knox, PhD National Children’s Study Program Office, NICHD, NIH, HHS
Philip Landrigan, MD Department of Community and Preventive Medicine, Mount Sinai
School of Medicine
Roberta Ness, MD, MPH Department of Epidemiology, University of Pittsburgh
Nigel Paneth, MD, MPH Department of Epidemiology, Michigan State University
Revised 5/14/08
Appendix C
C.5.5–2
Peter Scheidt, MD, MPH National Children’s Study Program Office, NICHD, NIH, HHS
Kenneth Schoendorf, MD, MPH National Center for Health Statistics, CDC, HHS
Stacy Scott In Black Print, Inc.
Updated May 2008
Revised 5/14/08
Appendix C.6
Incentive Plan
Appendix C
C.6–1
Incentives by Visit
Length of contact
in hours
Contact/Type of contact2,3
Pre-pregnancy
Planned incentive1
Types of data collection
Interview
Physical
Environmental
measures Biospecimens
samples
SAQs
Medical
Provider Log5
Self-collected
biospecimens
M
M
Self-collected
environmental
samples
Medical
record/Chart
abstraction
$100 monetary incentive
Pre-conception home visit
3.00
Pre-conception SAQs
1.00
1.00
Pre-conception follow-up home visit
Pre-conception--high-- 1st month
telephone call
0.25
Pre-conception--high-- 2nd month
telephone call
0.25
Pre-conception--high-- 4th month
telephone call
0.25
Pre-conception--moderate--3 month phone
call
0.25
Pre-conception--moderate--6 month phone
call
0.25
Pre-conception--moderate--9 month phone
call
0.25
Pre-conception--low--phone call every 6
months
0.25
Pregnancy
M
H
M
M
None
$25 non-monetary incentive
M
M
None
M
M
None
M
M
None
M
M
H
M
M
None
M
None
M
None
M
None
$100 monetary incentive
First trimester home visit--Mother
First trimester SAQs and biospecimens-Mother
2.25
M
H
1.00
M
First trimester follow up home visit--Mother 1.25
First trimester home visit--Father
First trimester SAQs--Father
1.25
1.00
First trimester follow-up home visit--Father
First trimester ultrasound 4 --Mother
16-17 weeks telephone call--Mother
2nd trimester ultrasound--Mother
1.25
1.00
0.25
1.00
M
M
F
M
H
M
M
None
M
$25 non-monetary incentive
$100 monetary incentive
F
F
F
M
None
F
None
Ultrasound report and image provided
None
Ultrasound report and image provided
M
M
M
M
M
$100 monetary incentive
Ultrasound report and image provided
3rd trimester clinic visit--Mother
3rd trimester SAQs, environmental
samples and biospecimens --Mother
36 weeks telephone call--Mother
2.50
M
M
M
M
M
H
1.00
0.25
M
M
M
M
None
None
Revised 7/7/08
Appendix C
C.6–2
Incentives by Visit
Length of contact
in hours
Contact/Type of contact2,3
Birth
Delivery hospital visit--Mother/Child
Interview
Physical
Environmental
measures Biospecimens
samples
2.00
SAQs
Medical
Provider Log5
Self-collected
biospecimens
Self-collected
environmental
samples
Medical
record/Chart
abstraction
M, C
Pre-discharge hospital visit--Mother/Child 3.00
C
1 month home visit (if birth visit missed)-Mother/Child
C
3.00
1 month home visit (agree to enroll at
hospital; enrolled at this visit)-Mother/Child
Post-natal
3 month telephone call
3.00
M
0.25
M
6 month home visit--Mother/Child
3.00
M
C
C
H
C
H
6 month SAQs and biospecimens--Mother 1.00
6 month follow up home/mail--Mother
1.00
6 month SAQs and biospecimens--Father 1.00
9 month telephone call--Mother
0.25
9 month by mail--Father
1.00
Planned incentive1
Types of data collection
C
M,C
C
M,C
C
M,C
C
M
C
C,M
M
H
F
M
None
None
F
$25
None
$25 non-monetary incentive mailed with SAQ
$100 monetary incentive
$10 non-monetary incentive
None
None
$100 monetary incentive
$10 non-monetary incentive
None
None
$40 mailed with request for self-collection
None
C
F
12 month home visit--Mother/Child
12 month SAQs--Mother
12 month followup visit--Mother/Child
3.00
1.00
1.00
M
12 month home visit--Father
12 month SAQs--Father
18 month telephone call--Mother
24 month telephone call
30 month telephone call
0.50
1.00
0.50
0.50
0.50
F
C
C
H
C
C
M
C
F
M
M
M
CC6
Received $50 check mailed around 36 week call
$25 non-monetary incentive
$100 monetary incentive
$25 non-monetary incentive
None
$100
$10 non-monetary incentive (baby item)
C
CC6
M
For both birth visits combined:
$50 monetary inentive--check mailed around 36
week call
$25 non-monetary incentive
C
C
C
H
KEY: M=Mother F=Father C=Child H=Place of residence CC=Child Care location(s) (Collections in child care centers are done by study staff and do not place burden on the mother, father or child.)
1 The non-monetary incentive value shown on the table reflects a potential value. We anticipate that the PO will determine a value that reflects NCS budget constraints and priorities.
2 Follow-up activity is initiated at in-person visit and requires action after the visit (e.g., return of SAQs and/or environmental samples or biospecimens).
3 See Key for indication of visit participant.
4 First trimester ultrasound is only done by the NCS if the mother does not already have an ultrasound done by her health care provider. If she does, the NCS will request permission to obtain ultrasound report from provider.
5 The Mother completes the medical provider log prior to (high pregnancy probability group only) and throughout her pregnancy; one is completed for the child after birth.
6 Child care centers will be subsampled for visits for data collection.
Revised 7/7/08
Appendix C.7
Certificate of Confidentiality
06/24/2008
NICHD
Dr. Peter Scheidt
6100 Executive Blvd, Room 5C01
Bethesda, MD 208927510
Dear Dr. Scheidt,
Enclosed is the Confidentiality Certificate protecting the identity of research subjects in your project entitled,
'National Children's Study (NCS)'. Please note that the Certificate expires on 12/01/2016.
Please be sure that the consent form given to research participants accurately states the intended uses of
personally identifiable information (including matters subject to reporting) and the confidentiality protections,
including the protection provided by the Certificate of Confidentiality with its limits and exceptions.
If you determine that the research project will not be completed by the expiration date, 12/01/2016, you must
submit a written request for an extension of the Certificate three months prior to the expiration date. If you make
any changes to the protocol for this study, you should contact me regarding modification of this Certificate. Any
requests for modifications of this Certificate must include the reasonfor the request, documentation of the most
recent IRB approval, and the expected date for completion of the research project.
Please advise me of any situation in which the Certificate is employed to resist disclosure of information in legal
proceedings. Should attorneys for the project wish to discuss the use of the Certificate, they may contact the
Office of the NIH Legal Advisor, National Institutes of Health, at (301) 496-6043.
Correspondence should be sent to:
Steven Hirschfeld, MD PhD
Associate Director for Clinical Research
Eunice Kennedy Shriver National Institute of
Child Health and Human Development
31 Center Drive, Room 2A03, MSC 2425
Bethesda, MD 20892-2425
Telephone: (301) 496-0044
Fax: (301) 480-1104
Sincerely,
Steven Hirschfeld, MD PhD
CERTIFICATE OF CONFIDENTIALITY
CC-HD-08-64
issued to
NICHD
conducting research known as
National Children's Study (NCS)
In accordance with the provisions of section 301(d) of the Public Health Service Act 42 U.S.C. 241(d), this Certificate
is issued in response to the request of the Principal Investigator, Dr. Scheidt to protect the privacy of research subjects
by withholding their identities from all persons not connected with this research. Dr. Scheidt is primarily responsible
for the conduct of this research, which is supported by the Eunice Kennedy Shriver National Institute of
Child Health and Human Development..
Under the authority vested in the Secretary of Health and Human Services by section 301(d), all persons who:
1
are enrolled in, employed by, or associated with the NICHD and their contractors or cooperating agencies and
2
have in the course of their employment or association access to information that would identify individuals
who are the subjects of the research pertaining to the project known as, National Children's Study (NCS)
are hereby authorized to protect the privacy of the individuals who are the subjects of that research by withholding
their names and other identifying characteristics from all persons not connected with the conduct of that research.
The National Children’s Study is a longitudinal cohort study designed to examine the effects of environmental
influences on child health and development. Environment is broadly defined to include biological, physical,
chemical, and social/cultural influences on children’s health and development. The study is based on a nationallyrepresentative sample of 100,000 children. Priority outcomes include obesity, diabetes, and physical development;
injuries; asthma; pregnancy-related outcomes; child development and mental health.
A Certificate of Confidentiality is needed because sensitive information will be collected during the course of the
study. The certificate will help researchers avoid involuntary disclosure that could expose subjects or their families
to adverse economic, legal, psychological and social consequences.
All subjects will be assigned a code number and identifying information and records will be kept in locked files at the
Institution.
This research will begin on 10/01/2008 and is expected to end on 12/01/2016.
As provided in section 301 (d) of the Public Health Service Act 42 U.S.C. 241(d):
'Persons so authorized to protect the privacy of such individuals may not be compelled in any Federal, State, or
local civil, criminal, administrative, legislative, or other proceedings to identify such individuals.'
This Certificate does not protect you from being compelled to make disclosures that: (1) have been consented to in
writing by the research subject or the subject’s legally authorized representative; (2) are required by the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or regulations issued under that Act; or (3) have been requested from
a research project funded by NIH or DHHS by authorized representatives of those agencies for the purpose of audit or
program review.
CERTIFICATE OF CONFIDENTIALITY
CC-HD-08-64
issued to
NICHD
conducting research known as
National Children's Study (NCS)
This Certificate does not represent an endorsement of the research project by the Department of Health and
Human Services. This Certificate is now in effect and will expire on 12/01/2016. The protection afforded by this
Confidentiality Certificate is permanent with respect to subjects who participate in the research during the time
the Certificate is in effect.
Date: 06/24/2008
_______________________
Steven Hirschfeld, M.D., Ph.D.
Associate Director for Clinical Research
Eunice Kennedy Shriver National Institute
of Child Health and Human Development
Appendix C.8
Sampling and Recruitment Plan
Appendix C
C.8–1
SAMPLING AND RECRUITING PLAN
1
Sampling Strategy
A number of study and sampling design options were considered for the NCS (see Sample
Design Options and other related documents available at http://www.nationalchildrensstudy.gov/
events/advisory_committee/other_work_062004.cfm). There are advantages and disadvantages to each of
the candidate approaches; however, after careful consideration and upon the advice of the NCSAC, a
national probability sample of all U.S. births was chosen as the design that best fulfills the following
goals:
Collection of high quality, objective data to minimize measurement biases
Avoidance of selection biases and other biases that could lead to invalid inferences
concerning exposure/outcome relations
Ability to capture the diversity of the U.S. population such that both the range and
diversity of exposures and outcomes are represented
Ability to generalize results of the NCS to the U.S. population.
The sample design for the NCS is a multistage probability sample of births in the United
States where the births are identified from a sample of households. The design includes two or three
stages of sampling.
The first stage of sampling was the selection of primary sampling units (PSUs), which
correspond to single counties or groups of contiguous counties. The second stage is the selection of
smaller geographic areas (segments) from within the primary sampling unit. In general, these segments
comprise city or suburban blocks or combinations of blocks and roughly correspond to neighborhoods.
The third stage, which applies only to very densely populated segments, involves the selection of groups
of households from within the segments. Each stage is detailed in the following subsections.
1.1
Selecting Study Locations
The process for selection of Study locations was based on the need to achieve representative
coverage of the United States with respect to geographic areas, metropolitan/nonmetropolitan areas, and
demography. All decisions on sample design options considered costs, coverage, statistical reliability, and
practical concerns of the protocol. Cost models and logistical aspects of the NCS data collection led to the
design decision to use 105 study locations.
The probability of a county being selected as a PSU is based on the number of births to
residents of that county. Because the number of births in a county at a future date cannot be known, data
on resident births (births based on the mother’s residency at the time of birth) from four recent years
(1999–2002, the most recent 4-year period available at the time) were used as an estimated measure of
size for sampling the PSUs.
The 3,141 U.S. counties were categorized into 18 large strata defined by metropolitan status
(metro, nonmetro) and geography (nine census divisions). Within each of the 18 large strata, the total
number of births determined the initial number of smaller strata. Based on their number of births, 13
counties were large enough to be designated as self-representing units (also referred to as certainty units).
Revised 07/02/08
Appendix C
C.8–2
For three of these counties, the number of births was so large that each county was assigned multiple
PSUs. Los Angeles County was assigned four PSUs; Cook County, IL, (containing Chicago) was
assigned two; and Harris County, TX, (containing Houston) was assigned two. These are units that were
“certain” to be selected into the probability sample based on their large number of births. Thus, the design
contains 13 locations but 18 PSUs that are considered self-representing.
The remaining 3,128 counties were placed into smaller strata. Within each of the 18 large
strata, these smaller strata were formed to be of roughly equal size. The smaller strata were defined in
terms of the size of county or the percent of births with specific characteristics. The characteristics used to
define the smaller strata were percent of births to Native American women, percent of births to Asian
women, percent births to Hispanic women, percent of births to Black women, and percent of low birth
weight. After all strata had been formed, one PSU per strata was selected with a probability proportional
to size (i.e., number of births).
A minimum measure of size for a PSU was established as 2,000 births during a 4-year period
(or an average of 500 births per year). If a county was selected that had fewer than 500 births per year,
geographically adjacent counties in the same stratum were added until the PSU met the minimum
measure of size. In a few cases, that criterion could not be achieved. For such cases, an additional PSU
was selected.
The final first stage sample comprised 110 PSUs in 105 locations: 26 locations are non-selfrepresenting PSUs from nonmetropolitan strata, 66 locations are non-self-representing PSUs from
metropolitan strata, and 13 locations with 18 PSUs are from self-representing metropolitan strata.
Although this design is generally consistent with an equal probability sample design, differences in the
sizes of the strata relative to the PSU probability of selection results in some variation.
1.2
Sampling within Locations (PSUs)
To meet the analytic needs of the Study, a total sample size of 1,000 enrolled live births is
the target for each sampled PSU. With an enrollment period of 4 years, a sample size of 250 enrolled live
births per year in each PSU is needed. (The Vanguard Centers have an additional year of enrollment and
thus have 1,250 targeted births.) Because each selected PSU has greater than 250 births expected per year,
a sample of births within each PSU must be designed and selected. This leads to the second stage of
selection for the NCS. It is not feasible to take a simple random sample of births within each PSU. The
second stage of the NCS design consists of forming small geographic units within a PSU called segments
(or secondary sampling units) and then selecting a sample of those segments for inclusion into the Study.
1.3
Segment Sampling
To increase the operational efficiency, reduce costs, and provide for more useful
representation of neighborhood-level characteristics, the segments within the PSUs are “clusters” of
households. A geographic classification used by the U.S. Census Bureau (blocks nested with block
groups, block groups nested within census tracts) is used to form segments. An advantage of using census
geography is that data from other sources for these units can be linked to the sampled segments.
Prior to the formation of segments in a PSU, a target number of sampled segments is
established. This number is primarily based on operational considerations and varies between PSUs. For
most PSUs, it is expected that the number of sampled segments will be between 10 and 15. In general, a
smaller number of segments are targeted in more rural, less densely populated PSUs that cover large
areas; in more densely populated PSUs with larger numbers of births, the number of sampled segments
Revised 07/02/08
Appendix C
C.8–3
may be larger. The segments are constructed to be as uniform in size as possible within a PSU, but slight
departures from the target segment size are expected.
As was done for the selection of PSUs, segments will be stratified to improve the precision
of estimates and to ensure the sample is representative with respect to the stratum definitions. The NCS
segments will be formed by combining a number of census blocks or block groups. Stratification can be
done either before or after segments are formed. When stratification is done beforehand, the
characteristics of the block groups can be used to form strata and only block groups in the same strata are
then combined to form segments. When stratification is done afterward, contiguous block groups can first
be clustered to form segments and then “similar” segments are grouped to form strata.
It is expected that the segment stratification scheme will vary from PSU to PSU, with a goal
of achieving locally defined neighborhoods as segments. (It is hoped that using locally defined
neighborhoods will increase study participation rates and facility data collections at the community level.)
Within most PSUs, geographic stratification will be used either as the sole stratifying variable or in
combination with other variables. Geographic stratification is useful because many of the characteristics
that differentiate subpopulations (such as income, race/ethnicity, educational attainment, and
environmental measures) tend to be geographically clustered.
The strata are formed as equal in size as possible so that with approximately equal-sized
segments, an approximately equal probability sample of segments is obtained. In some cases, it is
desirable to allow for some variations in stratum sizes within a PSU to construct more homogenous strata
than an equal-sized-strata scheme would permit. If the strata vary in size within a given PSU, the
segments also vary in size across strata to equalize the sampling fraction within each stratum. For
example, if one stratum is twice as large as another stratum within a given PSU, the segments within the
first stratum are constructed to be twice as large as the segments within the second stratum.
In some cases, the strata are not geographically contiguous. This is typically the case when
variables other than geography are used for segment stratification. In these cases it is necessary that each
disjointed part of a stratum be large enough to form complete segments with minimal variation in segment
size.
One challenge in having PSUs that have different sizes (number of births) is the large
variation in the number of possible segments across PSUs. For example, among the Vanguard Centers,
the smallest PSU has only 11 segments whereas the largest has approximately 18,000 (in the population
not the sample). A large number of segments causes difficulties in both forming and reviewing segments.
In order to use resources more efficiently, a three-stage sampling protocol is used for large PSUs
(typically those with more than 500 segments).
In large PSUs, geographic units are formed within strata and these geographic units, which
vary in the total number of estimated births, are sampled with the probability of selection proportionate to
the size (estimated births) of the geographic unit. Within each stratum, exactly one geographic unit is
selected. Segments are then formed within the sampled geographic unit to be equal in size (estimated
births). Across strata, the segments are made equal in size if the strata are equal sized, or vary in size
proportionate to the variation in stratum sizes if the strata are not equal sized. Within each sampled
geographic unit, exactly one segment is randomly selected.
1.4
Listing and Enrollment
In selected segments, household screening is attempted in all households (dwelling units;
DUs) in the segment. The exception is a very large segment, which cannot be subdivided during segment
Revised 07/02/08
Appendix C
C.8–4
formation. In such segments, DUs are subsampled. If one of these large segments is selected, the segment
is divided into “chunks” and then a chunk is randomly sampled for listing and enrollment. For example,
suppose a given segment is twice as large as the target segment size and consists of two very large
apartment buildings that contain approximately equal numbers of DUs. In that case, each apartment
building is a chunk, and one of the two is randomly selected to be retained in the sample. Other
approaches for chunking (depending on the situation) include using floors of apartment buildings or block
faces as chunks.
Household screening is attempted in each sampled DU, and all eligible women are enrolled.
The scheduled monitoring of eligible women is dependent on each woman’s likelihood of becoming
pregnant. Women more likely to become pregnant are contacted more frequently. This contact will be
used to update the status of enrolled women’s likelihood of pregnancy and thus her schedule for followup visits. In some instances, the composition of the household will change or the DU will have new
occupants. To enroll births from mothers in these situations, all DUs will be contacted again at least once
during the enrollment period. (Although this is the current plan, alternatives involving more frequent
contact are currently under consideration.)
1.5
Rollout of PSUs
A sample of seven PSUs was selected to serve as the Vanguard Centers. These seven
Vanguard Centers will serve as a platform to develop methodologies and procedures that will be refined
and implemented throughout the Study. The remaining 98 PSUs will be introduced in three waves. The
specific plan for the subsampling of the PSUs into the waves is currently under consideration. Pilot data
collection is planned to begin in the Vanguard Centers in late 2008, data collection in the first wave of
additional PSUs is planned to begin in early 2010 with the release of the second and third waves to follow
later.
The 98 PSUs not covered by the Vanguard Centers will be covered in the subsequent waves
by the addition of Study Centers. Each Study Center will oversee participant recruitment and data
collection at one to three geographically proximal study locations. The Vanguard Centers and Study
Centers will work with the NCS Coordinating Center and the NCS Program Office to ensure effective
development and implementation of study procedures.
1.6
Subsamples
In addition to the core set of measurements collected from all study participants, a number of
data collections are being considered that involve collection of survey information, samples, or biological
specimens from a subset of the total population or only at the community level. One example would be to
reduce the proportion of samples obtained with nonmeasurable concentrations of an environmental
substance. Questionnaire information on recent pesticide applications could be used to determine what
homes will have air samples collected for nonpersistent pesticides since the air concentrations of these
chemicals tend to decrease over time. Pesticide measurements in drinking water currently are being
planned only in rural areas for homes using private wells because municipal water system information
would be available for other locations and pesticide concentrations in drinking water in urban areas often
are below detection limits. In some cases, environmental samples will be collected but not analyzed (e.g.,
metals in dust) unless biomarker concentrations (e.g., blood levels) indicate higher exposures have
occurred, and there is a need to determine the media or sources contributing to this exposure.
Additionally, the large sample size of the National Children’s Study affords the opportunity for more indepth studies of subsamples within the framework of the longitudinal cohort study. Finally, to optimize
the study’s ability to incorporate state-of-the-art measurements, including some too costly or too
burdensome for implementation in a sample of 100,000, the use of a validation sampling approach might
Revised 07/02/08
Appendix C
C.8–5
be considered for certain measures. In this approach, a simple or less costly assessment is paired with the
more costly or burdensome approach in a planned subsample of the population. For example, personal
monitoring may be the best way to measure direct exposure to air pollutants or pesticides, but the cost and
intrusiveness of this monitoring make this impractical to use on the entire cohort. The relation between
the two assessments of the same domain is used to characterize and adjust for “measurement error” in the
analysis of exposure-outcome relations for the entire cohort, although the majority of the study
participants receive only the simpler, less expensive assessment. Similarly, a matrix approach for other
applications (e.g. varying times of assessment) is also being considered.
2
Participant Recruitment
2.1
Recruitment Goals
The goal of recruitment is to obtain the highest response rate possible to reduce the potential
for nonresponse bias. The minimum goal for combined response and coverage in each location will be
between 65–75 percent. Study locations with traditionally lower survey participation rates will have lower
targets. For example, in highly urban areas response rates for surveys are often considerably lower than in
other settings.
To assess the impact of nonresponse bias, studies will be undertaken to assess the differences
between responders and nonresponders. Lower response rates are acceptable only if it can be
demonstrated that the nonrespondents are missing at random, or if a nonresponse assessment provides an
adequate statistical procedure to adjust NCS estimates for nonrandom missingness. This combination of
rigorously conducting the Study to obtain response rates as high as feasible along with studying the
characteristics of nonrespondents is consistent with new standards and guidelines developed and
distributed by the Office of Management and Budget.
2.2
Enumeration of Households
Within selected segments (or chunks), all households will be enumerated to identify women
of child-bearing age living in the household. This enumeration will be conducted in person by trained
interviewers using computer-assisted personal interviewing techniques. An adult household reporter (age
18 or older) will be asked to answer questions about the number of household members, the number of
males and females, and for females, their ages and their relationships to the household reporter. To ensure
coverage of all dwelling units within each structure, questions will also be asked about other dwelling
units that may not be easily visible or obvious, and therefore may have been missed during the listing
process.
Two groups of eligible women are targeted for enrollment: women who are in their first
trimester of pregnancy and women between the age of majority and 49 years of age who are at some
probability of becoming pregnant during the 4-year enrollment period. After the eligible women are
identified from the household enumeration, a separate pregnancy screener will be completed with each
woman to determine her status. This will be done using a standardized set of questions related to her age,
history of prior births, contraceptive use, and sexual activity. To ensure privacy these questions the
pregnancy screener will be administered in-person using computer-assisted self-interviewing techniques,
which allow the woman to enter her responses directly into the computer. An audio feature of this will be
included to read the questions to the woman to further ensure privacy and to circumvent possible literacy
issues.
Women who are not currently pregnant and who are not actively trying to become pregnant,
or who are trying to become pregnant but based on the pregnancy screening have a relatively low
Revised 07/02/08
Appendix C
C.8–6
probability of becoming pregnant, will be categorized as either “low probability” or “moderate
probability.” These groups will receive periodic phone contacts to determine if they have either become
pregnant or, based on a limited set of screening questions, have moved to the group at higher probability
of pregnancy. Women who are at high probability of becoming pregnant will be enrolled in the
preconception cohort and actively followed for four menstrual cycles following enrollment. It is estimated
that 55.2 percent of women in this group will become pregnant during this timeframe.
There will be periodic rescreening of households in selected segments to monitor for “moveins” and other changes in the composition of the household living at each address. This will be an
important mechanism for monitoring changes in household composition as well as for identifying young
women who “age in” (i.e., turn 18) during the 4-year enrollment period.
2.3
Recruitment through Prenatal Care and Other Mechanisms
The primary mechanism for recruiting women for the Study is by contacting them in their
households and encouraging them to participate in all phases of the Study. Some women, however, will
move into sampled segments after the segments have been screened (and prior to the recontacts discussed
above). Since children born to women living in the sampled segments are eligible, other mechanisms are
needed to identify and recruit these women.
A supplemental mechanism to recruit eligible women (those living in the sampled segments)
is through providers of prenatal care, birthing centers, and hospitals. All of the requirements of those
sampled in households must be satisfied by these women, so this is simply another technique for
identifying and recruiting eligible women from sampled households. In addition to increasing the Study’s
ability to cover the mobile population that otherwise would be missed, this supplemental recruitment also
provides another opportunity to encourage participation from women who previously chose not to
participate in the Study when contacted in the household screening. While this method is useful in
reducing nonresponse and undercoverage, it does not provide full data from the pre-pregnancy and early
pregnancy data collections and is thus viewed as a supplemental approach.
3
Community Outreach and Engagement
The NCS values community engagement, but it will not follow a strict community-based
participatory research model. Community-based participatory research is defined as a collaborative
research approach designed to ensure and organize participation in all aspects of the research process and
action, emphasizing participation by the communities affected by the issue being studied, by
representatives of organizations, and by researchers. Because the protocol includes data collection from
multiple study sites to answer specific study questions that require a national sample, it was not possible
to define the core study questions and initial protocol development through input of local communities or
to account for their varied needs. However, principles of community-based research will be applied when
feasible and appropriate. A partnership with each community will be formed to ensure mutual respect and
the establishment of an enduring relationship. Genuine community engagement offers the hope of
enhancing recruitment, retention, and participant satisfaction.
Since the beginning of planning, the NCS has undertaken a range of community engagement
activities to lay the groundwork for Study Center activities. Between 2000 and 2005, the NCS conducted
many focus groups to obtain community perspectives on informing communities about the NCS, gaining
the support of communities, recruiting and retaining participants, and conducting NCS sampling and
visits. Additionally, the establishment of working groups, the Study Assembly, and the Federal Advisory
Committee allowed ongoing community input into the Study plans. The Vanguard Centers are working
Revised 07/02/08
Appendix C
C.8–7
within local communities to prepare for recruitment. Study Centers will continually share experiences
with and learn from each other in implementing community engagement plans.
Ideally, Study Centers will be able to build upon prior local community networks and
relationships. However, the unique sampling strategy, data collection intensity, and length of the NCS
necessitate different approaches to working with communities than previous studies or projects. To build
trust, enhance the credibility of the Study, and ensure community engagement on the local level, the
investigators from the Centers will conduct community needs assessments to identify children’s
environmental health issues in the target community during the first year of the Study. These assessments
will focus on community concerns regarding the core NCS protocol and additional concerns (e.g., health
issues) that may be considered for inclusion in the core protocol at all sites or as a specific sub-study
focus in the particular site. Community activities will include identification of community representatives
and resources and recruitment of community partners to facilitate engagement. Examples include advance
contact with community leaders to gather information about the community, town meetings, and listening
sessions. Key community members will be recruited and engaged in support of the Study in activities
such as acting as a spokesperson for the Study, providing insight into local issues to enhance the
relevance of the NCS for their community’s health, and serving on community advisory boards. Reliance
on secondary data sources like environmental and geographic data actually can enhance these activities.
Previous studies have shown the importance of involving community members, either in the actual data
collection for the study or as liaisons to special populations such as the medically underserved. These
approaches will be utilized at the Study Centers to the extent possible.
Prior to the enrollment period, each Study Center will increase the awareness of the Study
among community residents. Building on the community engagement efforts and involvement of
community members described above, a variety of strategies will be used to announce the NCS
enrollment period. Examples include press releases, appearances on local television and radio shows, and
other methods to increase community excitement and interest. Wherever possible, these activities will
involve joint participation of study staff and community members. These press and public relations
activities will have the technical support of the Coordinating Center and the NCS Program Office, with
the approval of the NCS Project Officer.
Throughout the Study, the Study Centers will involve and solicit input from the community.
Examples of ongoing activities include establishing a community advisory board, partnering with other
organizations to host events or forums, incorporating community leaders into the Study Center structure,
and building referral networks between the Study and organizations. Steps for community engagement
will vary depending on the characteristics and experiences of the communities and the Centers, and it is
expected that the most effective approaches will vary. Once data collection begins, communities will be
interested in learning about Study findings. Aggregate findings will be shared with individual participants
and communities through newsletters, publications, and other means. The community perspective can
inform NCS researchers on ways to be sensitive to unique cultural and political issues and to concerns
within each community when communicating results. Because the NCS is a long-term research effort,
attention to sustaining community relationships will be very important.
Revised 07/02/08
Appendix C.9
Data Collection from Community Members/Medical Providers
Appendix C
C.9.1–1
Motivation for participating in the NCS: Collecting feedback from participants in NCS
community events and from respondents who enroll in the NCS
Objective:
The National Children’s Study is committed to community engagement in the planning and
implementation of the Study. Specifically, the November 2004 RFP to create Vanguard Centers
recognized the importance of “identifying community resources and recruiting community partners to
facilitate engagement,” and required contractors to “develop and implement a plan for community
participation and engagement to support recruitment and retention efforts for the Study.” 1
The Vanguard Centers will invest a lot of time and effort in organizing and implementing different types
and numbers of community engagement activities with the hopes that these activities will build
awareness and interest in the National Children’s Study, ultimately facilitating enrollment. The
objective of this evaluation is to collect information on what motivates women to enroll in the NCS, and
whether the community outreach and promotion activities correlate to higher enrollment rates.
Additionally, the evaluation will measure what factors contribute to continued participation in the study
such as participant satisfaction with the NCS experience. Similarly, the evaluation will also ascertain
whether higher retention rates in the study correlate with participation in and positive perceptions of the
various community engagement activities.
As a secondary objective of this evaluation, measures of participant satisfaction with the NCS
experience can be used to refine data collection procedures and training in the future. Additionally,
these satisfaction measures can serve as a source of information to OMB in regards to the perceived
burden of participating in this study.
High Level Research Questions:
1) How do participants in the various community outreach and promotion activities rate the
activities in terms of improving their overall perception of the NCS and the NCS objectives?
2) How comfortable do participants feel voicing their personal opinions or participating in a
dialogue at the various community outreach and promotion activities?
3) Do the ratings obtained from the outreach and promotion activities correlate with enrollment
rates (at the VC) level?
4) Do either of the following measures differ between those who chose to enroll in the study and
those who don’t: reported participation in at least one NCS-sponsored activity, and awareness of
the NCS prior to an interviewer contacting the household.
5) For women who chose to participate in the study, what factors influenced their decision to
participate? Do these same factors influence their continued participation?
6) Does the respondent’s reported experience with data collection activities influence their
continued participation in the NCS?
1
RFP. National Children’s Study. NIH, NICHD. 2004. Available at:
http://www.nationalchildrensstudy.gov/research/study_plan/index.cfm Accessed December 6, 2006
1
Appendix C
C.9.1–2
General Design
To address each of the research questions we will collect data at several different points. The following
table shows each data collection point by research question. All data collections for this evaluation,
except for one, will use a self-administered, paper questionnaire (SAQ). It is likely that respondents will
feel more comfortable and will provide more honest feedback about their experience with the NCS if
they are given the opportunity to respond privately using a self-administered questionnaire (SAQ), rather
than providing feedback directly to the interviewer.
Research Q
Number.
1, 2, 3
When Collected
Who Participates
Method of Collection
At close of NCS
sponsored event
All event
attendees asked to
complete
4
At the screener
interview
All women asked
to complete the
audio-casi
pregnancy
screener
5, 6
At the end of each
personal visit
interview (P1, T1first (pick-up
visit), T3)
All enrolled
women who
complete some
portion of the P1,
T1, or T3 data
collection
SAQ completed and
returned at event or
mailed in a postage
paid envelope
provided at the event
Built as an intro to the
pregnancy screener
instrument but asked
by the interviewer
before starting the
audio-casi instrument
SAQ completed at the
end of the visit.
Questionnaire
Community
Activities
Engagement
Questionnaire
Questions within
the Pregnancy
Screener
Participant
Evaluation
Questionnaire.
Evaluating Community Engagement Activities
Fully evaluating the community engagement activities requires two separate data collections. The first
data collection, which covers the first three research questions, asks all participants of an NCS
sponsored activity to evaluate the activity by completing a short, paper, self-administered questionnaire
(SAQ). The NCS staff should hand out the SAQs to all attendees of the NCS sponsored event at some
point during the activity, though the exact timing will vary depending on the forum. Regardless of when
participants receive the SAQ, NCS staff should ask them to complete it and return it before leaving the
event. If, however, the forum does not lend itself to completing the SAQ on site, the NCS staff should
provide a postage paid return envelope along with the SAQ.
Since the community engagement activities will vary from Center to Center, the VCs will need to tailor
the questionnaire to each activity for which evaluation data are needed. Specifically, the VC’s will need
to
•
Label the questionnaire to identify the event covered by the evaluation,
•
Add a unique identifier (ID number) to each questionnaire, and
•
Add in the appropriate term or title for the event within the questions.
2
Appendix C
C.9.1–3
Additionally, the VCs will need to consider the best timing for distributing the questionnaire during the
activity. The VC’s will work with the program office to identify which community engagement
activities will include the evaluation SAQ.
The second data collection effort in the evaluation of the community engagement activities will assess
whether participation in the community events and/or awareness of the NCS prior to a visit from NCS
staff influenced a person’s decision to participate in the NCS (research question number 4). In answering
this research question, the evaluation tool must collect data from both women who do and women who
do not ultimately enroll in the study. Additionally, to understand the relationship between attendance at
the NCS sponsored events and participation in the NCS, this data collection must include people who
did and did not attend events. (Data collected at the close of NCS sponsored activities cannot speak to
this question since those questionnaires will not include the necessary identifying information to link to
respondents in the NCS.) Thus, these data will be collected as part of the pregnancy screening
interview. When the screening interviewer identifies an age-eligible woman in a household, the
interviewer will ask the woman a short set of scripted questions before starting the pregnancy screener.
The screening instrument will include these questions just prior to the start of the audio-CASI portion of
the interview minimizing any disruption in the flow of the interview. (See Appendix A.1.1.b questions
PS038 to PS041t). Since these questions do not explicitly evaluate the interviewer, the events or the data
collection activity, respondents should feel comfortable providing responses to the interviewer directly
(rather than using an SAQ).
To summarize, evaluating the community engagement activities will include two separate data
collection components. First, data that speak to participant’s perceptions of a specific activity will occur
at the close of the activity (or at some other point in the activity identified by the VCs as more
appropriate) using a paper self-administered questionnaire. Second, data that speak to whether
awareness of the NCS or participation in any of the community engagement activities influence
participation in the NCS will be collected by the NCS interviewer as part of the pregnancy screening
interview. These two data collection efforts address research questions 1 through 4.
Evaluating NCS (Pilot) Data Collection Activities
Research questions 5 and 6 address what factors influenced a participant’s decision to enroll in the
study, as well as assess whether their experience with the study influences their continued participation.
To answer these questions, the NCS will collect evaluative data from women who have enrolled in the
study and completed at least one data collection visit using a short, paper, self-administered
questionnaire (SAQ). The NCS interviewer can briefly explain the purpose of this questionnaire and ask
the respondent to begin completing it as he/she begins the final visit close-out, including the collection
of the environmental equipment. To the extent possible, the data collector should ask the respondent to
complete this SAQ before giving the respondent the final visit payment. Women who do not complete
every component of the visit (e.g., do not provide one of the biologic measures) still will be asked to
complete this evaluation questionnaire at whatever point the interviewer begins the visit close-out
activities.
Since the last research question includes assessing whether the respondents experience in the NCS data
collection influences their continued participation, we suggest asking participants to complete the
“Participant Evaluation Questionnaire” (See Appendix A.2.1.h) after each of the personal visit data
collections (P1, T1-first, T3), rather than at some set period of time after enrollment. Asking for this
3
Appendix C
C.9.1–4
feedback at particular data collection points will allow the analysis to control for different amounts and
types of experience which could greatly influence how participants respond.
Each of the evaluation questionnaires are included on the following pages.
4
Appendix C
C.9.1–5
QUESTIONNAIRE ADDRESSING:
EVALUATION OF COMMUNITY ENGAGEMENT
ACTIVITIES
5
Appendix C
C.9.1–6
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
NATIONAL CHILDREN’S STUDY
Activities (Community Engagement Activities) Questionnaire
Thank you for participating in this National Children’s Study (NCS) Activity. We would
appreciate you taking a few minutes to answer some questions about your overall impression
of the NCS Activity. Your feedback will help us improve the National Children’s Study for
future phases of the Study in which you or your child may choose to participate. Please
answer these questions to the best of your ability.
Completion of this form is voluntary and you can choose to complete it or not. If you do not
complete it, your eligibility to participate in the National Children’s Study will not be affected. As
with all other activities, the information you provide will be kept confidential and used only for
purposes of the Study.
1. How did you hear about the National Children’s Study? (check all that apply)
a. Friends
Yes
_____
No
_____
Don’t
Know
_____
b. Family
_____
_____
_____
c. Church, Synagogue, or other places of worship
_____
_____
_____
d. Community leaders
_____
_____
_____
e. Someone else in my community (other than the National
Children’s Study researchers)
_____
_____
_____
f. Your doctor or health care provider
_____
_____
_____
g. Newspaper, TV, radio
_____
_____
_____
h. Billboard
_____
_____
_____
i. A letter in the mail
_____
_____
_____
j. Someone from the Study came to my door
_____
_____
_____
k. Other
_____
_____
_____
Public reporting burden for this collection of information is estimated to average 3 minutes per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it
displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda,
MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this address.
6
Appendix C
C.9.1–7
2. How did attending [name of this activity] affect your opinion about the National
Children’s Study?
Mark one box
□ [The activity] helped me feel more positive about the Study
□ [The activity] did not change my opinion about the Study in any way
□ [The activity] raised more questions or concerns about the Study
3. How comfortable did you feel voicing your personal opinions at the NCS [name of
this activity]?
Mark one box
□ Very comfortable
□ Somewhat comfortable
□ Neither comfortable or uncomfortable
□ Somewhat uncomfortable
□ Very comfortable
4. Do you think you will attend another NCS Activity?
□
□
□
Yes
No
Maybe
Thank you for taking the time to complete this questionnaire.
Please put your completed questionnaire in the envelope provided and return the
questionnaire to one of the NCS event staff. If you prefer, you also can return your completed
questionnaire by mail using the postage-paid envelope.
7
Appendix C
C.9.2–1
Healthcare Provider and Community Leader Evaluations
Healthcare Provider Evaluation:
The Pilot also will collect data from health care providers in order to understand whether
a relationship exists between health care provider awareness and involvement in the NCS
and overall enrollment in the NCS. The Healthcare Provider questionnaire is very brief,
only 4 questions, and we estimate it taking any one provider less than a minute to
complete. This evaluation data, coupled with information about the costs for outreach
and promotion to healthcare providers (at a VC level) will be analyzed relative to
enrollment rates. This information will inform outreach and promotion activities for the
main Study.
To collect these data, each VC will develop a frame of healthcare providers in their area
from which 650 providers will be sampled. The VCs will each assemble their own
frame, including OB-GYN practices, prenatal clinics or other similar type health care
providers that serve women expected to give birth at the hospitals or birthing centers in
the VC area. To the extent possible, the frame will list by practice or clinic rather than
individual provider to minimize the possibility that any one practice will have multiple
providers selected to participate in this evaluation. In the event that a practice has
multiple locations, each location will be listed separately on the frame.
Data will be collected primarily by mail, with an in-person follow-up for those sampled
practices that do not respond by a certain date. The first contact will be a letter addressed
to the Medical Director of XXXX Practice telling him or her about the purpose of the
Study, why the Study needs their feedback and approximate date/week they will receive
it in the mail. About 7 to 10 days after the advance letter, the VCs will send the single
page questionnaire with a postage-paid return envelope to the same individual. A small
value, non-monetary incentive will be included with the questionnaire. About a week
after sending the questionnaire, the VCs will send a postcard to each sampled unit (but
again addressed to the medical director) reminding them to take one minute to complete
and return the questionnaire. If after 2 more weeks, the VC does not have a response
from the sampled unit, study staff from the VC will visit the practice to collect the
questionnaire. If the director (or his/her designee) has not completed the form, the
interviewer will ask to complete it then.
Because each VC will implement this evaluation independently, they will monitor the
data collection progress themselves. This will not be integrated into the IMS for the
Pilot.
Appendix C
C.9.2–2
Community Leader Evaluation
Also as part of the Pilot, each VC will collect feedback from community leaders included
in the outreach and promotion efforts within their VC for the purpose of understanding
whether gaining support from these community leaders impacts overall enrollment rates
in the VC. Specifically, the evaluation will focus on the level of awareness of the NCS
reported by community leaders and their reported support for the NCS relative to
enrollment rates. As with the Healthcare Provider evaluation, analysis of these data, and
costs data, will inform outreach and promotion activities for the main study.
Each VC will identify the community leaders asked to complete the form. It’s
anticipated that outreach efforts within a VC will target specific community leaders or
community groups. Thus, rather than sampling specific persons or groups from a larger
list, only the specific leaders or community groups included in the outreach efforts will
be asked to complete an evaluation form. The form itself is a single page asking only
four questions. Given that the outreach and promotion activities include personal
contacts with these individuals by design, study staff working on the outreach program at
each VC will hand deliver the questionnaires to the community leader or groups. Since
the questionnaire is so short, ideally the NCS staff person will complete the questionnaire
with the target individual, but a postage paid return envelope also will be provided.
Follow-up for non-responders will be by phone after the initial visit.
Since each VC will implement this evaluation independently, they will monitor the data
collection progress themselves. This will not be integrated into the IMS for the Pilot.
Appendix C
C.9.3–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
NATIONAL CHILDREN’S STUDY
Healthcare Provider Questionnaire (Draft)
Thank you for your interest in the National Children’s Study (NCS). Please take a
moment to answer a few questions about your experience with the study. Your
feedback will help us improve the National Children’s Study for future phases of the
study. Please answer these questions to the best of your ability.
1. How familiar are you with the National Children’s Study?
□
□
□
□
Very familiar
Somewhat familiar
Not too familiar
I have not heard of the National Children’s Study
2. In your opinion, how valuable do you think the National Children’s Study will
be to the health and well-being of children?
□
□
□
□
Not at all valuable
A little valuable
Pretty valuable
Very valuable
3. Have you taken steps to encourage any of your patients to enroll in the
Study?
□
□
Yes
No
4. How much of a burden is it for you when a patient of yours enrolls in the
National Children’s Study?
□
□
□
□
Very burdensome
Somewhat burdensome
A little burdensome
Not at all burdensome
Thank you for taking the time to complete this questionnaire.
Please put your completed questionnaire in the envelope provided and return the
questionnaire to the study representative. If you prefer, you can also return your completed
questionnaire by using the postage paid envelope.
Public reporting burden for this collection of information is estimated to average 3 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond
to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this
burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH,
Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not
return the completed form to this address.
Appendix C
C.9.4–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
NATIONAL CHILDREN’S STUDY
Community Leader Questionnaire
Thank you for your interest in the National Children’s Study (NCS). Please take a
moment to answer a few questions about your experience with the study. Your
feedback will help us improve the National Children’s Study for future phases of
the study. Please answer these questions to the best of your ability.
1. How familiar are you with the National Children’s Study?
□
□
□
□
Very familiar
Somewhat familiar
Not too familiar
I have not heard of the National Children’s Study
2. In your opinion, how valuable do you think the National Children’s Study
will be to the health and well being of children?
□
□
□
□
Not at all valuable
A little valuable
Pretty valuable
Very valuable
3. Have you taken steps to encourage community members to enroll in the
Study?
□
□
Yes
No
4. Do you expect the National Children’s Study to have a positive impact on
your community?
□
□
Yes
No
Thank you for taking the time to complete this questionnaire.
Please put your completed questionnaire in the envelope provided and return the
questionnaire to the study representative. If you prefer, you also can return your
completed questionnaire by using the postage-paid envelope.
Public reporting burden for this collection of information is estimated to average 3 minutes per response, including the time
for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and
reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently valid OMB control number. Send comments
regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this
burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA
(0925-xxxx*). Do not return the completed form to this address.
Appendix C.10
Day Care Centers Protocol
Appendix C
C.10.1–1
CHILD CARE LOCATIONS SUBSTUDY APPROACH
The NCS approach to studying children’s exposures during the time they spend in child care
locations is through studying a statistically based subsample of the NCS births through what is called the
Child Care Locations Substudy.
This document presents an overview of definitions and concepts needed for the substudy,
which child care locations to include, sample design, and the general approach to assessing the child care
environment. Two instruments to be used to determine quality characteristics of the child care location
also are included.
1.
Definitions and Concepts
A few key terms must be defined:
Child care is defined as “care that occurs on a regular basis by someone other than the
child’s parents.” Regular means that it occurs at least once per week.
The type of child care refers to the person providing care as well as the location in
which the care takes place. Child care is broadly defined as being either center-based
or home-based. Center-based care and home-based care are mutually exclusive.
Center-based care takes place in a child care center or facility. Home-based care is
provided by a relative or a non-relative in a home, either the child’s home, the
provider’s home, or another home. Because the NCS focuses on the environment and
environmental exposures in the child’s home, the Child Care Substudy is focusing on
the environment and environmental exposures that occur outside the child’s home.
Child care type is further broken into what we are referring to as “locations” for this
study. We use the term “locations” to refer to the location in which a child care
arrangement occurs (e.g.., a center, the child’s home, or someone else’s home). This
way of classifying child care arrangements is presented in Table 1.
A classification system that divides care into center-based or home-based, the relationship of
the provider to the child, and the location where care takes place is consistent with other major studies
including the Early Childhood Longitudinal Study, Birth Cohort (ECLS-B), the National Household
Education Survey (NHES), the NICHD Study of Early Child Care and Youth Development (SECCYD),
and the Survey of Income and Program Participation (SIPP).
1
Appendix C
C.10.1–2
Table 1. Child Care Types and Locations
Center-Based
Center
Home-Based
Non-relative
Relative
In Child’s
Out of Child’s
In Child’s
Out of Child’s
Home
Home
Home
Home
Environmental exposures
Child care environment
Note: Gray shaded cells are excluded from the proposed Child Care Substudy because the environmental exposures in the child’s
home will be assessed as part of the core assessment. The cells filled with slanted lines are partially excluded from the Child Care
Substudy. These providers will not be asked to participate in the child care provider telephone interview and no separate child
care observation will be conducted. However, there will be an opportunity to collect some child care information from these
providers if the mother names that person as the alternate caregiver to be interviewed in the core assessment. Regardless of
whether an observational component is added to assess environmental influences, it will be important to ensure that questions for
the alternate caregivers who are not fathers collect parallel information to that collected from caregivers in the Child Care
Substudy. For example, it would be beneficial to collect information on proxies for child care quality, such as provider education
and training and beliefs about caregiving.
2.
The NCS Child Care Substudy is tasked with assessing both environmental exposures
in the child care setting and the child care environment itself. To help differentiate
these two types of environmental factors, we will use the term environmental
exposures to refer to assessments pertaining to measuring toxins in the environment.
We will use the term environmental influences to refer to other characteristics of the
study child’s child care environment. The child care environment includes such
influences as the quality and quantity of child care, the stability of child care, and
other features of the child care environment that may affect a child’s social,
emotional, and cognitive development and health.
Which Child Care Locations Will Be the Focus of the Study
Because of the longitudinal nature of the study and the focus on child health exposures, the
Substudy will be child-based with assessments occurring in the actual child care locations of study
children. 1
A child-based design will lead to assessments in the child care arrangements of study
children. The Substudy will look at a census of locations used (at standard data collection points,
currently 6 months and 12 months) by selected children. To implement this, a random subgroup of
children would be placed into the Child Care Substudy at birth. Only those children in the Child Care
Substudy would have their child care environment observed. 2 If the child currently uses a child care
location for a sufficient duration of time (defined as a function of hours per week and months since
1
We considered but rejected the possibility of selecting child care arrangements within a community where child care is provided
rather than the actual care locations of study children. Under a locations-based study option, child care centers and/or home-based
arrangements would be sampled and assessed. The location assessed would not necessarily (or likely) be a location where a study
child is currently enrolled but rather would be sampled based on its being in the community where the child is located. Only
locations which could be identified (e.g., licensed or otherwise listed) would be included. Some in-home child care locations are
licensed, but many are not and thus would be excluded. In addition, it could be difficult to obtain lists of in-home licensed
locations.
2
It is important to note that only a percentage (roughly half) of children enrolled in the Child Care Substudy will be in regular
child care at any point in their preschool years.
2
Appendix C
C.10.1–3
arrangement began), the location will be studied. 3 Assessments would take place in the actual child care
arrangements of study children. All locations meeting the requirement for the minimum number of hours
will be observed. A variety of criteria would be used to define further which arrangements would be
studied.
The optimal strategy for understanding all of children’s exposures is to assess a census of the
locations ever attended by children selected for the Child Care Substudy. While it would be ideal to assess
every child care arrangement that a child ever attends, from a practical and budgetary standpoint, the
focus will be on arrangements that the child is currently attending at predetermined data collection points
that mirror those in the main study.
3.
Sample Design
Any location that a child selected for the Child Care Substudy has regularly used for child
care would be eligible for the study, assuming it is a significant source of exposure. Exposure is a
combination of the hours of use per week and number of weeks used. (Exposure also is a function of the
environmental levels at the location but this is not known until after the sample of locations is selected.)
We anticipate a two-tier eligibility rule: All locations used for child care by the child at the time of a
regular core visit (e.g., 6 months and 12 months) used 30 hours will be studied, and a sample of 10
percent of those locations used 10 to 29 hours would be studied. In addition, all locations used 10 or more
hours per week would be contacted by telephone to collect environmental influences information.
It is important to collect both environmental exposure and influences from the 10 percent
sample of less-used locations since the conditions in heavily used locations might not accurately reflect
the conditions in less-used locations. In addition, it is necessary to include data from less-used locations
so that it is possible to minimize the effect of selection biases. Children are not randomly assigned to
child care. There are geographic, socioeconomic, family, and child factors that effect dimensions of child
care, such as the type of care selected and how much child care is used (age of entry and amount of care),
that also affect child developmental and health outcomes. For example, family economic factors, maternal
employment status, mothers’ education, personality, and beliefs, and family size are associated with child
care use (Hofferth et al., 1991; NICHD Early Child Care Research Network, 1997a). To make inferences
about relations between child care and child outcomes, it is necessary to identify and control selection
biases.
We anticipate including 20 percent of the pilot births (roughly 220 children) in the Substudy.
The plan is to use the results to impute child care influences and exposures for all 100,000
children in the NCS cohort. (This will allow child care influences and exposure data to be used when
modeling outcomes for the entire cohort.) Parents of children not in the Substudy would also be asked
questions about the extent and location of child care. This would be used to identify similar potential
exposures among Substudy children.
3
The minimum threshold for number of hours per week and length of time in the setting varies across major studies. For
example, one criterion for an arrangement to be “observable” in the NICHD SECCYD is that the infant is in the arrangement for
at least 10 hours per week. A criterion of 8 hours per week was used for preschoolers. For the ECLS-B, an interview with the
child’s primary child care provider was conducted for any child with a regular arrangement, and an observation of a child’s child
care arrangement was conducted for any child (sampled for the child care observation component) with a regular arrangement
that occurred for at least 10 hours per week.
3
Appendix C
4.
C.10.1–4
Measuring the Environment in the Child Care Setting
The first step in measuring the child care environment is identifying the environment of
interest. To do this, the mother must first be asked questions about child care usage. The 6- and 12-month
instruments will both have questions to allow the mother to report what arrangements the child has and
provide permission for us to visit them.
Second, it is important to develop a plan that allows sufficient data to be collected to meet
the multiple goals of this study.
Environmental exposures: The Child Care Locations Substudy will mirror exposure data
collection at the 6-month home visit. A few measures of environmental exposures that are planned for the
child’s home may not be needed in a center setting. There is currently no plan to leave air monitors or
other equipment in the child care location overnight. One additional test (fecal cultures from selected
surfaces) has been proposed. Additional work is ongoing to see if any reductions can be made in the 6month home protocol when it is applied to the Child Care Locations Substudy.
Environmental influences: The Child Care Locations Substudy will collect information on
the characteristics of the child care environment in center- and home-based settings through a telephone
interview with the child’s non-parental child care provider. For example, information will be collected
characteristics of the child care provider (e.g., education, training, knowledge of child development, and
caregiver beliefs and attitudes), the caregiver-child relationship, the provider’s assessment of the child’s
behavior and development, and other characteristics of the child care setting (e.g., other children in care,
language spoken in the setting, etc.). This has been a standard approach used on such large studies as the
ECLS-B, NHES, and the NICHD SECCYD. This data will be merged with data on the child’s child care
usage (e.g., quantity of care, stability of care) provided by all parents for analytic purposes.
5.
References
Abbott-Shim, M. & Sibley, A. (1992a). Assessment Profile for Early Childhood Programs. Atlanta, GA:
Quality Assist, Inc.
Abbott-Shim, M. & Sibley, A. (1992b). Assessment Profile for Family Day Care. Atlanta, GA: Quality
Assist, Inc.
Arnett, J. (1989). Caregivers in day-care centers: Does training matter? Journal of Applied Developmental
Psychology, 10, 541–552.
Blau, D. M. (1999). The effects of child care characteristics on child development. Journal of Human
Resources, 34, 786–822.
Caughy, M. O., DiPietro, J. A., & Strobino, D. M. (1994). Day-care participation as a protective factor in
the cognitive development of low-income children. Child Development, 65, 457–471.
Harms, T., & Clifford, R. M. (1980). Early Childhood Environment Rating Scale. New York: Teachers
College Press.
4
Appendix C
C.10.1–5
Harms, T., & Clifford, R. M. (1989). Family Day Care Rating Scale. New York: Teachers College Press.
Harms, T., Cryer, D., & Clifford, R. M. (1990). Infant/Toddler Environment Rating Scale. New York:
Teachers College Press.
Hofferth, S. L., Brayfield, A., Deich, S., & Holcomb, P. (1991). National Child Care Survey, 1990, report
91-5. Washington, DC: Urban Institute Press.
Hofferth, S. L., Shauman, K. A., Henke, R. R., & West, J. (1998). Characteristics of Children’s Early
Care and Education Programs: Data from the 1995 National Household Education Survey. Report
No. 98-128. Washington, DC: U.S. Department of Education, National Center for Education
Statistics.
Mulligan, G.M., Brimhall, D., & West, J. (2005). Child care and early education arrangements of infants,
toddlers, and preschoolers: 2001 (NCES 2006-039). U.S. Department of Education, National
Center for Education Statistics. Washington, DC: U.S. Government Printing Office.
NICHD Early Child Care Research Network (1996). Characteristics of infant child care: Factors
contributing to positive caregiving. Early Childhood Research Quarterly, 11, 269–306.
NICHD Early Child Care Research Network (1997a). Familial factors associated with characteristics of
nonmaternal care for infants. Journal of Marriage and Family, 59, 389–408.
NICHD Early Child Care Research Network (1997b). Child care in the first year of life: The NICHD
Early Child Care Research Network. Merrill-Palmer Quarterly, 43(3), 340–360.
NICHD Early Child Care Research Network (2000). Characteristics and quality of child care for toddlers
and preschoolers. Applied Developmental Science, 4, 116–135.
NICHD Early Child Care Research Network (2002). Early child care and children’s development prior to
school entry: Results from the NICHD Study of Early Child Care. American Educational Research
Journal, 39, 133–164.
Peisner-Feinberg, E. S., Burchinal, M. R., Clifford, R. M., Culkin, M. L., Howes, et al. (2001). The
relation of preschool child-care quality to children’s cognitive and social developmental trajectories
through second grade. Child Development, 72(5), 1534–1553.
Vandell, D. L., & Wolfe, B. (2000). Child care quality: Does it matter and does it need to be improved?
Madison: University of Wisconsin-Madison, Institute for Research on Poverty. Retrieved June 29,
2006, from www.irp.wisc.edu/publications/sr/pdfs/sr78.pdf
Wachs, T. D. (1986). Models of physical environment action: Implications for the study of play materials
and parent-child interaction. In A. E. Gottfried & C. C. Brown (Eds.), Play interactions: The
contribution of play materials and parent involvement to child development. Lexington, MA:
Lexington.
5
Appendix C
C.10.2-1
NCS PROTOCOL SUMMARY OF ENVIRONMENTAL SAMPLES TO BE COLLECTED
AT CHILD CARE LOCATIONS
9/11/2007
Dust
Method
% Visits
Allergens, endotoxin (+ temp & RH)
Mold
Inorganics (wipe to be archived)
SVOCs (wipe to be archived)
Vacuum
Vacuum
Wipe
100
100
100
Wipe
100
Wipe
100
Vacuum
100
Disinfection Byproducts (DBPs) - HAA9
Water
1 per segment/ system/ year
Disinfection Byproducts (DBPs) - THMs
Water
1 per segment/ system/ year
VOCs - non-community water source only
Water
12
Nitrate - non-community water source only
Soil
Water
12
Soil
100 (1 per structure)
Pesticides: Pyrethroids (composite, store 3 mos before analysis)
TBD (vacuum dust to be archived)
Drinking Water
Mid-yard soil (SVOCs - to be archived)
Visual Assessment - Building, Neighborhood - Indoor (and outdoor)
Page 1
Appendix C
C.10.3–1
Father’s Role in Child Care
Rationale:
Fathers contribute to the development of their children in a variety of ways, most
particularly emotional and economic support (Tamis-LeMonda and Cabrera
2002; Levine 1998; McBride, B., Rane, T.R., & Bae, J. 1999; Nord, C.W.,
Brinhall, D. & West, J. 1997). When it comes to child care arrangements, the
father’s role is primarily as a partner to the mother in making choices about the
arrangement that will work best for the family, given the availability and quality
of the child care available to the family. For example, local implementation and
center supply conditions may be important factors affecting parents’ child care
selections (Fuller, Kagan, Caspary, & Gauthier, 2002). Additionally, knowledge
about the father’s role in the selection and scheduling of child care provides
important information about the nature of the father’s involvement and the level
of stress and social support faced by the mother in negotiating work schedules
and child care arrangements.
In the National Children’s Study, the interview with the primary caregiver,
typically the mother, asks a variety of questions about the nature of current and
past child care arrangements that help to identify the types of arrangements (e.g.,
center-based vs. family child care vs. relative care), the amount of time the child
spends in this care, and indicators of the quality of these care arrangements. It
would be duplicative to ask the same questions of the father. On the other hand,
there are many factors that are in play when parents decide on a suitable child
care arrangement, and fathers may have different levels of involvement in these
decisions. Additionally, fathers may have differential levels of involvement and
participation in child care, from helping financially to taking the child to and
from the child care, to stepping in to provide emergency support in case the child
is ill or the child care is not available for a given day or period of time. The
degree to which the fathers are involved financially, physically, and emotionally
may affect the child’s development by providing resources to the child’s mother
that may offset the stress of her parenting role.
Hypotheses Involved:
Domain of Exposure for hypotheses:
#13
#15
#16
#17
Family Influences on Child Health and Development
Impact of Neighborhood and Communities on Child Health
Impact of Media Exposure on Child Health and Development
Social Institutions and Child Health and Development
Recommended Measure:
NICHD Early Child Care Study, My Child Questions (4 items). All four
items of these questions from the Study of Early Child are asked of the mothers
and would then be asked of fathers if they have contact with the child care
provider. These questions assess the father’s perspective on the relationship
Appendix C
C.10.3–2
between his child and the child’s caregiver. Items were answered according to
Likert-type scales, with the scale points and anchors differing according to each
question. As a result, the Cronbach’s Alpha for the composite variable summing
the scores across the four questions showed only moderate reliability
(Cronbach’s alpha’s at 6 and 15 months were 0.580 and 0.619 respectively).
Standardization of the items slightly improved the Cronbach’s Alpha’s and the
Study of Early Child Care suggested omitting item 2 from the composite because
it was poorly distributed at all assessment ages. Two additional questions were
included to ask about procedures and plans if the respondent’s child (or other
children in care) is sick. The ability of the caregiver to isolate and remove sick
children so as not to spread infection has been shown to be a good indicator of
overall quality of the child care environment.
NICHD Study of Early Child Care, Current Child Care Grid (Form 10A, 1
item). To identify the factors that fathers perceived as the reasons for the
selection of the child care arrangement used most often, one item from this
instrument was included. There is extensive literature on child care choices and
the link between family resources, incomes, and education levels as well as the
existing market conditions for the availability of different child care types on the
choices parents make.
Early Head Start National Evaluation, 14-Month Father Interview,
Questions on father’s responsibility in child care arrangements. Three items
taken from the EHS 14-month father interview determine the degree to which the
father is involved in picking up or dropping off the child at the child care
provider. One additional item asks about the sharing of costs for child care
between the parents.
Child Care Decision Making (Longitudinal Study of Australian Children). In
the father interview or self-administered questionnaire, we propose asking the
same set of questions asked of the mother regarding the father’s role in choosing
a particular child care arrangement, from questions asked as part of the
Longitudinal Study of Australian Children. Several items will ask the father
about his role in choosing and organizing child care. Another item from the
NICHD Study of Early Child Care was added asking for the different reasons
why respondents chose the forms of child care that they were using.
How Interview Component Will Be Conducted:
SAQ, CAPI, or CATI
Longitudinal Characteristics:
6 months, 12 months, and 18 months
Estimated Burden:
Allocated per interview: 6 minutes
Estimated from Literature: N/A
Estimated from Pilot Test: To come
Appendix C
C.10.3–3
Other Options Considered:
None.
Issues:
Other questions already proposed for the father interview capture additional
information regarding the father’s provision of support to the mother regarding
work schedules, financial and emotional support, including his contribution to
child care.
Sources:
Administration for Children and Families. (2006). Early Head Start Research and
Evaluation Project, 2-year father interview. Retrieved April 10, 2006, from
http://www.acf.hhs.gov/programs/opre/ehs/ehs_resrch/instruments/father_interview_
2yrs/father_2yr_sec7.html
Australian Institute for Family Studies. (2002). Introducing the Longitudinal Study of
Australian Children. Discussion paper 1. Retrieved April 3, 2006, from
http://www.aifs.gov.au/growingup/pubs/dp1.html
Fuller, B., Kagan, S. L., Caspary, G. L., & Gauthier, C. A. (2002). Welfare reform and
child care options for low-income families. Future of Children: Children and
Welfare Reform, 12(1), 97–119.
Hirshberg, D., Huang, D. S., and Fuller, B. (2005). Which low-income parents select
child-care? Family demand and neighborhood organizations. Children and Youth
Services Review, 27(10), 1119-–1148.
International Center for Education Statistics. (n.d.). Early Childhood Longitudinal
Study—Birth cohort. Retrieved January 24, 2006, from
http://nces.ed.gov/ecls/Birth.asp
NICHD Study of Early Child Care. (1991). NICHD Study of Early Child Care Phase I
Instruments. Retrieved April 3, 2006, from
http://secc.rti.org/display.cfm?t=f&i=15K
Appendix C
C.10.4–1
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
Father’s Involvement in Child Care Arrangements—Father SAQ Items
Next, I’d like to talk to you about different the experiences that {CHILD} has in child care from someone
other than {{his/her} parents/you or {his/her} mother or guardians}. We are especially interested in how
fathers think about these experiences and the role they may play. Child care includes regular child care
and early childhood programs, whether or not there is a charge or fee, but not occasional babysitting.
Please answer these questions about the person or caregiver who overall spends the most time with
{CHILD} on a weekly basis. If you are not sure how to answer a question, you can just say that you
don’t know.
Section A. Father’s Role in Parental Child Care Decision-Making 1
A1.
First, please tell me who is the person, other than you or your {spouse/partner/the child’s mother}
who provides the most amount of care for {CHILD} on a weekly basis. Is he/she a …
Relative ..............................................................................................
Non-relative in a home .......................................................................
Child care center ................................................................................
Don’t know ........................................................................................
1
2
3
8 (GO TO B1)
Please answer the rest of these questions thinking only about this particular person who provides the most
amount of care for {CHILD} on a weekly basis.
A2.
Who chooses where your child goes for child care?
Mother only ......................................................................................
Mother mostly ....................................................................................
Mother and father equally ..................................................................
Father mostly .....................................................................................
Father only .........................................................................................
Someone else (Specify ________________)......................................
Don’t know ........................................................................................
A3.
1
2
3
4
5
6
8
Who schedules and organizes the child care arrangements?
Mother only ......................................................................................
Mother mostly ....................................................................................
Mother and father equally ..................................................................
Father mostly .....................................................................................
Father only .........................................................................................
Someone else (Specify ________________)......................................
Refused ...............................................................................................
Don’t know ........................................................................................
1
2
3
4
5
6
77
88
1
Source: Child Care Choices Study, Australia (A2, A3, A7), Early Head Start National Evaluation, 14 month Father
Interview (A4-A6)
Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any
other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch,
6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this
address.
Appendix C
A4.
Have you ever taken {CHILD} to child care or a child development center or picked up {CHILD}
from there?
Yes .....................................................................................................
No .......................................................................................................
Refused .............................................................................................
Don’t know ........................................................................................
A5.
C.10.4–2
1
2 (GO TO A7)
7 (GO TO A7)
8 (GO TO A7)
About how many times per month do you drop off or pick up {CHILD} from child care or a child
development center?
Number of times per month: ______ OR
Refused ..............................................................................................
Don’t know ........................................................................................
A6.
When you drop off or pick up {CHILD}, do you talk to the person who takes care of {CHILD}?
Yes .....................................................................................................
No .......................................................................................................
Refused .............................................................................................
Don’t know ........................................................................................
A7.
7
8
1
2
7
8
Who usually takes and picks up your child from child care?
Mother only ......................................................................................
Mother mostly ....................................................................................
Mother and father equally ..................................................................
Father mostly .....................................................................................
Father only .........................................................................................
Someone else (Specify ________________)......................................
No one, child is cared for at home .....................................................
Refused ..............................................................................................
Don’t know ........................................................................................
1 (GO TO C1)
2 (GO TO C1)
3 (GO TO C1)
4
5
6 (GO TO C1)
7 (GO TO C1)
77 (GO TO C1)
88 (GO TO C1)
If father answer “father mostly” or “father only” in A5, go to Section B, otherwise go to
Section C.
Section B. Respondent’s Relationship with Child Care Provider 2
We'd like to find out a little bit about the relationship between your child's caregiver(s) and your child.
For each of these statements, please select the best answer.
B1. Would you say that the relationship the caregiver(s) has with your child is
Very close and loving -- like a member of the family ........................
Positive, but not really close ..............................................................
2
Source: NICHD Study of Early Child Care, Form 15K, “My Child Care”
1
2
Appendix C
Neither positive nor negative, but "businesslike" ..............................
Not positive at all ...............................................................................
Refused ..............................................................................................
Don’t know ........................................................................................
C.10.4–3
3
4
7
8
B2. When you pick up your child from the caregiver/center (or when you come after the child has been
with the caregiver), does the child seem sad to leave the caregiver(s)?
The child cries when he/she leaves the caregiver ...............................
The child looks sad when he/she leaves the caregiver........................
The child does not seem to mind when he/she leaves the caregiver ..
Refused ..............................................................................................
Don’t know ........................................................................................
1
2
3
7
8
B3. When you drop the child off at the caregiver/center (or when the caregiver comes in the morning),
does the child seem happy to see the caregiver(s)?
Joyful—he/she lights up ....................................................................
Positive but not overjoyed .................................................................
Doesn't seem to care one way or another ...........................................
He/she is unhappy—looks sad ...........................................................
He/she is unhappy—sometimes even cries ........................................
Refused ..............................................................................................
Don’t know ........................................................................................
1
2
3
4
5
7
8
B4. When you drop the child off at the caregiver/center (or when the caregiver comes in the morning),
does the caregiver(s) seem happy to see the child?
Joyful—the caregiver lights up ..........................................................
The caregiver is positive but not overjoyed .......................................
The caregiver doesn't seem to care one way or another .....................
Refused ..............................................................................................
Don’t know ........................................................................................
1
2
3
7
8
Section C. Father’s Role in Filling Emergency Child Care Needs 3
C1. In the last 2 months, has CHILD been sick on a day that your family relied on child care?
Yes .....................................................................................................
No ......................................................................................................
Refused ..............................................................................................
Don’t know ........................................................................................
1
2 (GO TO D8)
7
8
C2. What did you or the child’s mother do about child care the last time that happened?
Child was in regular arrangement ......................................................
Stayed or went home from work/school ............................................
Father/partner stayed or went home ...................................................
Took child to work .............................................................................
3
Source: NICHD Study of Early Child Care, Form 15K, “My Child Care”
1
2
3
4
Appendix C
Relative cared for child ......................................................................
Friend or neighbor cared for child .....................................................
Hired sitter .........................................................................................
Older child stayed with child .............................................................
Used child care for sick children .......................................................
Other (Specify):____________________ .........................................
Refused ..............................................................................................
Don’t know ........................................................................................
C.10.4–4
5
6
7
8
9
10
77
88
C3. What usually happens when your child (or one of the other child(ren) in care) is sick?
The parent(s) has to make other arrangements
if the child is at all sick. ................................................................
The parent(s) has to make other arrangements
only if the child is very sick ..........................................................
The caregiver takes the child, but keeps him/her isolated from
other children (or there are no other children). .............................
The caregiver makes other arrangements for the child (has someone
else take care of him/her, etc. .......................................................
Other (Specify __________________________) ...............................
Refused ................................................................................................
Don’t know ..........................................................................................
1
2
3
4
5
7
8
C4. Who usually cares for your child when he/she is sick and cannot attend child care?
Mother only ......................................................................................
Mother mostly ....................................................................................
Mother and father equally ..................................................................
Father mostly .....................................................................................
Father only .........................................................................................
Someone else (Specify ________________)......................................
Refused ...............................................................................................
Don’t know ........................................................................................
1
2
3
4
5
6
77
88
C5. For the child care arrangement that you use the most, what factors influenced your and your
(spouse/partner)’s decision to use this particular arrangement? (MARK ALL THAT APPLY). 4
Cost .....................................................................................................
Convenient hours ...............................................................................
Convenient location ............................................................................
Quality of care provided .....................................................................
Quality environment/equipment .........................................................
Quality of program ............................................................................
Preference for relative provider .........................................................
Preference for home environment ......................................................
Preference for center environment .....................................................
Availability .........................................................................................
4
Source: NICHD Study of Early Child Care, Form 10A “Current Child Care Grid”
1
2
3
4
5
6
7
8
9
10
Appendix C
C.10.4–5
Other (Specify __________________________________________
__________________________________________________) ......
11
Refused ..............................................................................................
Don’t know ........................................................................................
77
88
C6. How do you and {CHILD’S MOTHER} share the costs of child care or the child
development center? 5
Do you share 50/50 ............................................................................
Do you pay most, or ...........................................................................
Does she pay most ............................................................................
Refused ..............................................................................................
Don’t know ........................................................................................
5
1
2
3
7
8
Source: Early Head Start Research and Evaluation Project, Two-Year Father Interview, “Child Related Services”
(A4-A6), “Child Support and Paternity” (C6)
Appendix C
C.10.5–1
Child Care Substudy Provider Interview
The Berkeley–Yale interviews for child care providers are telephone or in-person interviews designed to
capture the quality of the child care setting. These interviews cover physical features of the child care
setting, activities done in the setting, interpersonal interactions in the setting, and the relationship between
the provider and parents. Additionally, provider education and experience are included in the questions.
These questionnaires were designed to be used as an alternative to more burdensome observations of the
child care setting by a trained professional.
Administration Time:
20–30 minutes
Administration Method:
Interview of child care provider can be administered either in person or by phone. Plan is to
administer by phone at time of scheduling for environmental appointment.
Administration Procedures:
The interview is conducted with the child care provider and asks about the child care setting and
provider rather than about the child. There are two alternate forms, one for Child Care Centers
and the other for Family Day Care Homes. Only one of the two forms is administered to a
provider. The choice of form is determined by the type of child care setting.
Child Care Centers
This 22-item questionnaire covers a variety of aspects of quality of the child care center setting, including
space and furnishings, personal care routines, language-reasoning experiences, activities, interpersonal
interactions (staff–child and child–child) in the care setting, and parent relations and services. Questions
pertaining to caregiver background and training also are asked.
Family Day Care Homes
This 29–item questionnaire covers a variety of aspects of quality of limited-resource child care settings,
including space and furnishings, basic care routines, language-reasoning experiences, learning activities,
and parent–staff relations and services. Questions pertaining to the provider’s amount of experience in the
child-care field, education level, membership in a professional caregiver organization, and opportunities
to attend child-care related training or conferences also are addressed.
Appendix C
C.10.5–2
OMB #: 0925-xxxx
Expiration Date: xx/xxxx
Berkeley–Yale Telephone Interview for Child Care Centers (BYTI-C)
Introduction
Hello, my name is ________ and I am calling from __________. [Fill in particulars here
regarding how they were selected]. I’d like to talk with you about your child-care classroom. Our
conversation should take about 20 to 30 minutes. Is this a convenient time for you to talk?
(If YES: Great! Can we begin now?).
(If NO: I’d be happy to call back at a more convenient time if that would make a difference to
you.)
(If still NO: Thank you for your time.)
We know how challenging it can be a child-care teacher, given limited resources, space, and
time. In order for us to get an accurate picture, we ask that you listen carefully to each question
and respond with the answer that you feel best characterizes your classroom.
For the sake of time, it would be helpful if, as I read the questions, you respond with letter—a, b,
c, or d—of the response that best describes your classroom. At the end of the survey you will
have a chance to say more about particular questions I asked, if you choose.
Your responses are completely confidential and we will assign you an identification number
rather than use your name. Do you have any other questions before we begin?
Program Size
1. On a typical morning, that is, between 9 am and noon, how many children are present in your
classroom? _________ children
2. On a typical morning, including yourself, how many people work with you in the classroom?
By this, I mean people who are teachers or aides. ________ workers
Space & Furnishings
3. Different programs organize their space in different ways, especially as far as dividing rooms
into separate learning centers. Which of the following best describes your room?
a. There is not enough space or materials to establish separate learning centers.
b. There are at least 2 learning centers, but they are not separated from the rest of the
room.
c. There are at least 3 learning centers that are separated from the rest of the room and are
well-equipped.
Public reporting burden for this collection of information is estimated to average 25 minutes per response, including the time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing
the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection
of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any
other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch,
6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-xxxx*). Do not return the completed form to this
address.
Appendix C
C.10.5–3
d. There are at least 5 well-equipped learning centers providing a variety of learning
experiences. Children are able to help themselves to what they need.
Language-Reasoning Experiences
4. Sometimes budgets don’t allow child-care providers to purchase all the toys and materials they
would like. The next question refers specifically to the amount of educational materials relating
to language development, including books as well as music tapes and picture card games. Which
best describes your classroom?
a. There are few books in the classroom.
b. Children have enough books to avoid conflict, if several want to use them during free
play.
c. There is a wide selection of books available for a substantial portion of the day. Some
additional language materials are used daily.
d. The classroom has a large variety of materials in good condition present for free choice
and supervised use. There are enough materials of sufficient variety that the teacher
can rotate them every few weeks.
5. Now I am interested in communication activities such as talking about drawings, sharing ideas
at circle time, singing songs. Which of the following best fits your classroom?
a. There is rarely time for communication activities.
b. There are 1 or 2 communication activities a week.
c. Communication activities take place daily during both free play and group times.
d. The staff designs daily communication activities for free play and group time. Some of
the activities link children’s spoken communication with written language, for
example, a teacher writes down a story as the children dictate.
Activities
6. When it comes to materials involving fine motor skills and hand–eye coordination, such as
pegboards and puzzles, which best describes your class?
a. Few materials are present in the classroom. Some materials are missing pieces or are
damaged.
b. The classroom has some materials that are in fair to good condition, although the
classroom could use a wider variety of materials.
c. The classroom has many materials in good condition. Materials are on different levels
of difficulty.
d. There are enough good materials that you can rotate them every few weeks.
7. When it comes to art activities and materials, which best describes your setting?
a. There are few art materials available every day for the children.
b. There are some art materials, including those where children are able to express
themselves in their own way.
c. There are many, varied art materials accessible by the children. There is much
individual expression in the use of these materials.
Appendix C
C.10.5–4
d. In addition to option c, there are three-dimensional art materials such as clay. Some of
the art activities are related to other classroom experiences, such as painting with fall
colors when learning about the seasons.
8. Centers vary greatly on the amount of space and resources available to provide sand and water
play.
8a. Do you have provisions for sand play (or a similar material like rice) indoors?
a. Yes
b. No
8b. What about sand play outdoors?
a. Yes
b. No
8c. What about water play indoors?
a. Yes
b. No
8d. What about water play outdoors?
a. Yes
b. No
9. I am interested in the materials available for dress-up or dramatic play activities. Which best
describes your classroom?
a. There are no special materials available for dramatic play.
b. There are some props available for dramatic play, mostly to play house.
c. There is a variety of dramatic play props and they involve at least two themes. For
example, house keeping and work.
d. Dramatic play materials are rotated occasionally to provide a complete change of
themes. Pictures, stories and trips are used to enrich dramatic play.
10. Do the children have access to a television?
a. Yes
b. No
11. Do the children have access to a VCR?
a. Yes
b. No
12. When it comes to the amount that children are supervised as they play with gross motor
equipment such as tricycles, which best describes your classroom?
a. There is not always enough staff to watch children as they play with gross motor
equipment.
b. The children are supervised by staff to avoid accidents. Otherwise, children are
encouraged to play on their own.
c. Children using gross motor equipment are given help when they ask for it.
Appendix C
C.10.5–5
d. Staff talk with children as they play, asking them to talk about what they are doing.
Staff provide additional resources and guide children in their play.
13. For how much of the day are the children doing an activity as a whole group—such as
listening to a tape or doing the same art project?
a. Most of the day
b. 50–75% of the day
c. 25–50% of the day
d. Less than 25% of the day
14. How often do the children in your class use work sheets to learn a skill? By this we mean
exercises to learn their ABCs or practice numbers, not drawing or art.
a. Every day
b. A few times a week
c. A few times a month
d. A few times a year or never.
Interaction
15. Which of the following best describes your classroom as far as the amount and type of
interaction between staff and children?
a. Due to their many responsibilities, some staff members are sometimes too busy to
respond immediately when a child wants their attention.
b. The staff usually have the time to respond to children who ask for attention, but they
sometimes feel hurried.
c. The staff have ample time to listen to each child who wants attention.
16. As far as children’s interactions with each other, which best characterizes your classroom?
a. The children often seem to be by themselves or get into conflicts when they try to play
with peers.
b. The children’s interactions with peers are usually positive. They usually play well
together without fighting.
c. The children seem to have formed strong emotional connections with each other. They
play together and are usually able to resolve differences of opinion.
Parents and Staff
17. How much time were you able to spend during the last 12 months at child-related training
programs, workshops, or conferences?
a. Less than 5 hours
b. 5 to 10 hours
c. 11 to 20 hours
d. More than 20 hours
Appendix C
C.10.5–6
18. Are you a member of a formal group or association of people who work with young
children?
a. Yes
b. No
19. Some centers have the resources to provide for professional materials, workshops, courses,
and/or in-service training. Which of the following best describes your center?
a. The center doesn’t have the resources to provide professional materials or in-service
training.
b. There is some in-service training for staff and occasional staff meetings.
c. Monthly staff meetings are used to handle administrative concerns and include staff
development activities. Books and magazines about child care are available on-site.
d. Financial support is available for staff to attend conferences or workshops and to
purchase materials.
20. Are staff with less than an AA degree in early childhood education required to continue
formal education?
a. Yes
b. No
21. How long have you worked as a teacher or aide in the child-care field? ____________ years
22. What is your highest level of education? Stop me when I get to the one that applies to you.
a. Less than high school
b. GED, high school diploma, or CDA credential
c. Some college
d. 2-year/associate’s degree
e. 4-year/bachelor’s degree
f. Master’s degree
Is there anything you’d like to add about any of the questions I’ve asked? Thank you very much
for your help.
Appendix C
C.10.5–7
Berkeley–Yale Telephone Interview for Family Child-Care Homes (BYTI-F)
Introduction
Hello, my name is ________ and I am calling from __________. [Fill in particulars here
regarding how they were selected]. I’d like to talk with you about your family child-care home.
Our conversation should take about 20 to 30 minutes. Is this a convenient time for you to talk?
(If YES: Great! Can we begin now?).
(If NO: I’d be happy to call back at a more convenient time if that would make a difference to
you.)
(If still NO: Thank you for your time.)
We know how challenging it can be to run a child-care setting given limited resources, space,
and time. In order for us to get an accurate picture, we ask that you listen carefully to each
question and respond with the answer that best characterizes your setting.
For the sake of time, it would be helpful if, as I read the questions, you respond with the letter—
a, b, c, or d—of the response that best describes your family child-care home. At the end of the
survey you will have a chance to say more about particular questions I asked, if you choose.
Your responses are completely confidential and we will assign you an identification number
rather than use your name. Do you have any questions before we begin?
Program Size
1. On a typical morning, that is, between 9 am and noon, how many children are present in your
setting? _________ children
2. On a typical morning, including yourself, how many people work with you in your setting?
________ workers
Appendix C
C.10.5–8
Space & Furnishings
3. Family child-care settings vary as to the amount of space they have available to post childrelated pictures and art work. Which describes your child-care setting?
a. There is no space available to display child-related pictures, mobiles, or children’s art
work.
b. There is some children’s art work displayed and you have some store-bought or adultmade pictures for children to look at.
c. There is much children’s work displayed, at least two items per child enrolled. Some of
it is down low at the child’s eye level.
d. There are many items of interest to children displayed where the children can see them.
The display is changed at least monthly to match the children’s activities and interests.
4. Do you have any areas in your setting that are specifically set up just for one type of play, like
a block area or a dress-up area?
a. Yes
b. No
5. Which best describes how you prevent children from breaking fragile objects like flower
vases?
a. You teach children not to touch them.
b. You remove them from the areas used by children.
6. How satisfied are you with the amount of space you have for children?
a. Somewhat satisfied
b. Moderately satisfied
c. Very satisfied
7. We are interested in learning about the availability of items for active play, for example,
tricycles. Which best describes your child-care setting?
a. Little active play equipment is available at this time.
b. You have some equipment in good condition, but there is not a lot of variety.
c. The room has a wide variety of equipment in good condition.
d. The room has many different kinds of equipment in good condition. The equipment
stimulates skills on different levels. For example, tricycles with and without pedals.
Appendix C
C.10.5–9
Basic Care Routines
8. We’re interested in how things go when children arrive in the morning. Which of the
following is most like your child-care setting?
a. You are often too busy to greet children individually.
b. Most of the children and parents will be greeted as they arrive. With so many families
coming and going, however, some children may arrive without being greeted.
c. You greet each child and parent upon arrival.
d. You have a conversation with each child and parent upon arrival. You also use this
time to talk informally with the parents or to help a child become involved in an
activity.
9. How often do you have a chance to sit with the children while they are eating?
a. Never
b. Sometimes
c. Often
d. Always
Language-Reasoning Experiences
10. Sometimes budgets don’t allow child-care providers to purchase all the toys and materials
they would like. The next question refers specifically to the amount of educational materials
relating to language development, including books as well as music tapes and picture card
games. Which best describes your program?
a. There are fewer than 6 children’s books and no other materials available.
b. There are at least 10 children’s books and some other materials that you use at least 3
times a week.
c. There are at least 20 children’s books and various other materials for the children. You
have at least one daily planned activity, such as reading or saying nursery rhymes.
d. You check out materials from the library once a month or add to the material in other
ways and use them in daily activities.
11. On an average day, how many minutes per day does someone read aloud to the children?
________________ minutes
12. How often do you ask children specific questions about the story when you read aloud?
a. Every day
b. Most of the time
c. Sometimes
d. Rarely
Appendix C
C.10.5–10
13. Which best represents the type of informal conversation that takes place in your setting?
a. You talk with the children primarily while managing routines like toileting, or to
correct a child’s behavior.
b. You have time for short, social conversations with most of the children.
c. You have many conversations with children and try to make comments that build on
ideas presented by them.
d. You make sure to have a conversation with each child every day and often ask
questions to encourage them to talk more.
Learning Activities
14. When it comes to materials involving hand–eye coordination, such as pegboards and puzzles,
which best describes your setting?
a. At this time, I have no hand–eye coordination materials.
b. There are some hand–eye materials available for children to use independently.
c. There is a variety of hand–eye materials as well as space to play with the materials.
d. I have a wide range of materials that are rotated to maintain interest. They also are
organized and labeled to encourage self-help.
15. When it comes to art activities and materials, which best describes your setting?
a. There are no art materials available for use by children.
b. There are some materials, including drawing, at least twice a week.
c. There are crayons and paper, or other drawing materials available daily. Art materials
needing supervision are planned at least 3 times a week, such as cutting and pasting, or
painting.
d. There are at least 2 different activities offered daily. Activities include at least one 3dimensional material per week, such as clay or carpentry.
16. Family child-care homes vary greatly on the amount of space and resources available to
provide sand and water play.
16a. Do you have provisions for sand play (or a similar material like rice) indoors?
a. Yes
b. No
16b. What about sand play outdoors?
a. Yes
b. No
16c. What about water play indoors?
a. Yes
b. No
Appendix C
C.10.5–11
16d. What about water play outdoors?
a. Yes
b. No
17. I am interested in the resources available for dress-up or dramatic play activities. Which best
describes your child-care setting?
a. There are not special materials available for dramatic play.
b. There are some props available for dramatic play, mostly to play house.
c. There is a variety of dramatic play props and they involve at least two themes. For
example, house keeping and work.
d. There is a variety of props involving two themes. The props are arranged in their own
space and include child-sized play furniture, like a small stove or a baby stroller.
18. How often do the children have access to the computer?
a. Every day
b. A few times a week
c. A few times a month
d. A few times a year or never
19. How often do they have access to the television or videos?
a. Every day
b. A few times a week
c. A few times a month
d. A few times a year or never
20. How often do you talk with the children about what they are watching on the television or
VCR?
a. Always
b. Often
c. Sometimes
d. Rarely or never
21. How often do the children in your setting use work sheets to learn a skill? By this we mean
exercises to learn their ABCs or practice numbers, not drawing or art.
a. Every day
b. A few times a week
c. A few times a month
d. A few times a year or never.
Appendix C
C.10.5–12
Parents and Staff
24. Do you have a regularly scheduled parent conference?
a. Yes
b. No
25. I am interested in knowing how you are able to balance personal and caregiving
responsibilities. Which description best describes you?
a. Many housekeeping duties and family errands come up throughout the day.
b. You make some changes in your own schedule of housekeeping and family errands on
a day-to-day basis to meet caregiving responsibilities.
c. You make plans so that family responsibilities and caregiving seldom interfere with
one another. You have a substitute available as an emergency back-up.
26. Some providers have the opportunity to attend child-related training, workshops, or
conferences. How much time did you spend during the last 12 months at child-related training
programs, workshops, or conferences?
a. Less than 5 hours
b. 5 to 10 hours
c. 11 to 20 hours
d. More than 20 hours
27. Are you a member of a formal group or association of people who work with young
children?
a. Yes
b. No
28. We would like to find out a little bit about you and your job. How long have you worked as a
provider in the child care field? ____________ years
29. What is your highest level of education? Stop me when I get to the one that applies to you.
a. Less than high school
b. GED, high school diploma, or CDA credential
c. Some college
d. 2-year/associate’s degree
e. 4-year/bachelor’s degree
f. Master’s degree
Is there anything else you’d like at add about the questions I’ve asked you?
Thank you very much for your help.
Appendix C.11
Reports of Findings and Referrals
Appendix C
C.11–1
National Children’s Study: Report of Findings and Referrals
APPENDIX C: REPORT OF FINDINGS AND REFERRALS
1.
Overview
Participants in the National Children’s Study (NCS) will be informed through the consenting
process that only those results obtained during a given visit will be provided to the respondent.
The Visit Information Sheets will specify exactly which tests results respondents will receive
during a given study visit. For the first stage of the study (i.e., pre-pregnancy through child age 3),
these test results will be limited to height/length, weight, body mass index, and blood pressure,
depending upon the age of the participant as described below. Field researchers will provide
results to respondents through the hard copy document, Report of Findings, as well as referral
information at the time of the visit.
This strategy of revealing findings to study participants reduces misunderstandings of study
practices as replacing regular medical care. However, there may be occasions where other test
results completed after the visit indicate risk to respondents or communities. In these scenarios,
the NCS director will be advised by the Data Safety and Monitoring Board (DSMB) and relevant
IRBs through established information flow. Procedural details for such occasions are described
below.
2.
Report of Findings
Participants will receive a written Report of Findings after completing a physical exam, either at
home or at a clinic. This report will include height/recumbent length, weight, body mass index,
and blood pressure, depending upon the age of the participant. See Table 1. For persons 6 and
older, it will also include a brief interpretation of the visit results based on predetermined criteria
as cited in the Report. These criteria will take into account the age and sex of the participant.
The Report also lists a toll-free referral number for participants to use for follow-up questions
about results. The Visit Coordinator will review the results verbally with the participant.
Appendix C
C.11–2
National Children’s Study: Report of Findings and Referrals
Table 1.
Age Categories by Physical Measurement Reported
Measure
Age
Length
Birth through age 3
Height
3 and older
Weight
Birth and older
Body Mass Index
20 and older
Blood pressure
12 months and older
Ultrasound images will also be provided to the mother for each study-scheduled visit (i.e.,
trimester 1, if not already scheduled; trimester 2 and trimester 3).
Recumbent length/height and weight: Participants will receive recumbent length of children up
to and including 3 years of age, and height for persons age 3 and older (both forms of
measurement are taken at age 3). All participants will be given their weight. Although
measurements are recorded in metric units for data collection purposes, the results for the Report
of Findings will be converted to English units. These measurements will be printed on the hard
copy report along with a brief interpretation of the results.
Body Mass Index (BMI): BMI, adjusted for sex, will be calculated for persons ages 20 years and
older. The technician will check the appropriate statement based on the body mass index
percentile. Table 2 shows the statements for this age group associated with each body mass
index category.
Table 2.
Statements by BMI categories for report of findings (20 years and older)
Report of Findings Statement for weight status based on BMI:
Body Mass Index
“Body mass index (BMI), a number calculated from a person’s weight and
height, is a measure of body fatness. Although it does not measure fat
directly, research has shown that BMI is related to direct measures of body
fat. Your weight status category can be determined from the table below:”
Below 18.5
Underweight
18.5–24.9
Normal
25.0–29.9
Overweight
30 and above
Obese
Appendix C
C.11–3
National Children’s Study: Report of Findings and Referrals
Blood pressure: Blood pressure will be given to participants ages 6 and older. Relevant
standards vary by age, as described below.
Children’s normal blood pressures vary by age, weight, and height. The tables for children’s
blood pressures are taken from the National High Blood Pressure Education Program Working
Group on Hypertension Control in Children and Adolescents. 1 The tables display systolic and
diastolic blood pressure results by percentile of height for males and females ages 6 through 17
years. Systolic and diastolic blood pressure are then categorized by range and assigned an
interpretation based on clinical standards, as cited in Table 3. If the results are above the normal
range (categories 3—4), referral procedures will be followed as described in section 3.
Table 3.
Statements by result category for blood pressure report of findings (ages 6-17)2
Category
Report of Findings Statement
“You child’s blood pressure today …”
1
…is within the normal range.*
2
…is normal but at the high end of normal range.*
3
…high.*
4
… very high.*
For persons 18 and older, systolic and diastolic blood pressure are categorized by range and
assigned an interpretation based on clinical standards for this age group, as cited. For example,
Table 4 shows the blood pressure category (1–5) for the systolic and diastolic blood pressure
combination. The category number indicates the statement to be used for the report of findings. If
the results are above the normal range (categories 3—5), referral procedures will be followed as
described in section 3.
1
National High Blood Pressure Education Program Working Group on Hypertension Control in Children and Adolescents. Update on
the 1987 Task Force Report on High Blood Pressure in Children and Adolescents: A Working Group Report from the National High
Blood Pressure Education Program. Pediatrics. 1996; 11:649–658.
Appendix C
C.11–4
National Children’s Study: Report of Findings and Referrals
Table 4.
Statement by result category for blood pressure report of findings (adults 18+) 1
Category
Systolic
Diastolic
Report of Findings Statement:
“Your blood pressure today is…”
1
<120
<80
…within the normal range. 21
2
120-139
80-89
…above normal and is in the pre-hypertensive range. 1
3
140-159
90-99
…high. 1
4
160-209
100-119
…very high. 1
5
>209
>119
…severely high.
Ultrasound image: Participating women will be given an image from each of the ultrasounds
performed as part of the study. Ultrasounds are planned for each trimester of the participant’s
pregnancy. However, a first trimester ultrasound will not be scheduled on behalf of the study if the
participant has a first trimester ultrasound already planned as part of her prenatal care and
agrees to share those ultrasound results with the study. In that case, the study would not provide
an image of that first trimester ultrasound to the participant. Referral numbers will be available
from the field technician for participants to use for follow-up questions, but the participant is
informed through the consenting process that ultrasound image interpretation will not be provided
and that ultrasounds scheduled for study purposed do not replace medical care.
2
Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
NIH Publication, 2003
Appendix C
C.11–5
National Children’s Study: Report of Findings and Referrals
Exhibit 1. Sample Report of Findings (Birth through 2 years)
Participant name:
Date of visit:
Body Measurements
/ 20
Blood Pressure and Heart Rate
.
Recumbent length:
cm.
pounds
Could not obtain
Blood pressure:
/
mmHg
Could not obtain
Not measured at this visit (less than 1 yr of age)
Could not obtain
Weight:
/
ounces
Heart rate:
beats per minute
Could not obtain
Not measured at this visit (less than 1 yr of age)
Your child’s blood pressure today is:*
N/A
Within the normal range
Above the normal, in the pre-hypertensive range
High
Very high
Severely high
We recommend that:
N/A
No action is needed.
You discuss these findings with a healthcare
provider at your child’s next visit.
Your child sees a healthcare provider within 2
weeks.
Your child sees a healthcare provider immediately.
Name of data collector:
Staff ID:
* Categories are based on the National High Blood Pressure Education Program Working Group on High
Blood Pressure in Children and Adolescents, The Fourth Report on the Diagnosis, Evaluation, and Treatment
of High Blood Pressure in Children and Adolescents. Pediatrics 2004 114: 555-576.
The purpose of the study examination is data collection, not diagnosis or treatment. The study
examinations are not intended to substitute for a clinical exam. Adults should see their doctor
once a year for an annual exam.
If you have any questions about the information on this form, please see the Local Contact
Sheet.
Appendix C
C.11–6
National Children’s Study: Report of Findings and Referrals
Exhibit 2. Sample Report of Findings (3 years through 19 years)
Participant name:
/
Date of visit:
/ 20
Body Measurements
Blood Pressure and Heart Rate
Weight:
Blood pressure:
pounds
Not measured at this visit
Could not obtain at this visit
.
Recumbent length*:
*age 3 only
Height:
mmHg
Could not obtain at this visit
cm.
Heart rate:
Could not obtain
feet
inches
Not measured at this visit
Could not obtain at this visit
/
beats per minute
Could not obtain at this visit
You/your child’s blood pressure today is:**
Within the normal range
Above the normal, in the pre-hypertensive range
High
Very high
Severely high
We recommend that:
No action is needed.
You discuss these findings with a healthcare provider
at you/your child’s next visit.
You/your child see a healthcare provider within 2
weeks.
You/your child see a healthcare provider immediately.
Name of data collector:
Staff ID:
** (3 through 17 years) Categories are based on the National High Blood Pressure Education Program
Working Group on High Blood Pressure in Children and Adolescents, The Fourth Report on the Diagnosis,
Evaluation, and Treatment of High Blood Pressure in Children and Adolescents. Pediatrics 2004 114: 555576.
** (18 years and above) Categories are based on the Seventh Report of the Joint National Committee on the
Prevention, Detection, Evaluation and Treatment of High Blood Pressure. NIH Publication, 2003
The purpose of the study examination is data collection, not diagnosis or treatment. The study
examinations are not intended to substitute for a clinical exam. Adults should see their doctor
once a year for an annual exam.
If you have any questions about the information on this form, please see the Local Contact
Sheet.
Appendix C
C.11–7
National Children’s Study: Report of Findings and Referrals
Exhibit 3. Sample Report of Findings (20 years and above)
Participant name:
/
Date of visit:
/ 20
Body Measurements
Blood Pressure and Heart Rate
Weight:
pounds
Not measured at this visit
Could not obtain at this visit
Blood pressure:
feet
inches
Not measured at this visit
Could not obtain at this visit
Heart rate:
Height:
.
Body Mass Index:
Not measured at this visit
Could not obtain at this visit
Body Mass Index (BMI) is a number calculated
from a person’s weight and height. It is a
measure of body fatness. Although it does not
measure fat directly, research has shown that
BMI is related to direct measures of body fat.
Your weight status category based on your BMI
can be determined from the table below:
Body Mass Index
Below 18.5
18.5 – 24.9
25.0 – 29.9
30 & above
Weight Status
Underweight
Normal
Overweight
Obese
/
mmHg
Could not obtain at this visit
beats per minute
Could not obtain at this visit
Your blood pressure today is:*
Within the normal range
Above the normal, in the pre-hypertensive range
High
Very high
Severely high
We recommend that:
No action is needed.
You discuss these findings with a healthcare provider
at your next visit.
You see a healthcare provider within 2 weeks.
You see a healthcare provider immediately.
Name of data collector:
Staff ID:
* Categories are based on the Seventh Report of the Joint National Committee on the Prevention, Detection,
Evaluation and Treatment of High Blood Pressure. NIH Publication, 2003
The purpose of the study examination is data collection, not diagnosis or treatment. The study
examinations are not intended to substitute for a clinical exam. Adults should see their doctor
once a year for an annual exam.
If you have any questions about the information on this form, please see the Local Contact
Sheet.
Appendix C
C.11–8
National Children’s Study: Report of Findings and Referrals
3.
Referrals
Although the purpose of the NCS examinations is data collection, not diagnosis or treatment,
physical exams may yield clinically significant findings available at the time of visit that warrant
further medical attention. Below we describe procedures in these scenarios.
The only exam result available at the end of the exam to establish the need for a referral is blood
pressure. Exam results are classified into three referral levels. Referral letters and forms will be
given for results that fall in Level 1 and 2 categories.
Level 1: Major medical findings warrant immediate attention by a health care provider.
Level 2: Major medical findings require attention by a health care provider within the next
two weeks. The examinee may experience adverse health effects within this
time frame.
Level 3: Normal medical findings or minor medical findings that an examinee already
knows about, is under care for, or that does not require prompt attention by a
medical provider.
Level 1 findings: In the case of Level 1 findings, the Visit Coordinator will end the exam
immediately and provide the respondent with a standard referral letter (Exhibit 3) in addition to a
referral form with specific information regarding the results (Exhibit 4). The Visit Coordinator
verbally will instruct the participant to see his/her health care provider immediately. If the
respondent does not have a primary care provider, the name and contact information for a doctor
from the Study Center’s health care provider referral list will be provided. This information will be
written on the referral form. If the examiner believes the participant is in imminent danger, he or
she will also call 911 for medical assistance.
Level 2 findings: In the case of Level 2 findings, the Visit Coordinator will be responsible for
providing the respondent with a standard referral letter (Exhibit 3), a referral form with specific
information regarding the results (Exhibit 4), and instructions to see his/her primary care provider
within 2 weeks. If the respondent does not have a primary care provider, the name and contact
information for a doctor from the Study Center’s health care provider referral list will be provided.
This information will be written on the referral form.
Level 3 findings are normal medical findings that do not require a referral, or minor medical
findings that an examinee already knows about, is under care for, or that does not require prompt
attention by a medical provider.
Appendix C
C.11–9
National Children’s Study: Report of Findings and Referrals
Exhibit 4. Sample Standard Referral Letter for Physical Measure Results at Levels 1 or 2
Date of visit:
/
/ 20
Dear Healthcare Provider:
is participating in the National Children’s Study
{Name of participant}
which is led by the U.S. Department of Health and Human Services—through the National
Institutes of Health and the Centers for Disease Control and Prevention—and the U.S.
Environmental Protection Agency. One of the objectives of the National Children’s Study is to
obtain information on the health and development of U.S. children. This examination is
intended to collect health measures for research and is not a complete physical exam.
No attempt has been made to diagnose or treat medical conditions of the participant.
As a result of the testing that was done, a finding was revealed that was outside of the study’s
medically acceptable range. The finding disclosed to you is done so with the participant’s
permission.
Blood pressure was measured in a seated position after resting quietly for several minutes.
Three measurements were taken; the first measure was discarded and the average systolic and
diastolic blood pressures were calculated from the remaining readings. The results are recorded
below. Referral categories are based on:
♦
Ages 6–17 yrs: National High Blood Pressure Education Program Working Group on High
Blood Pressure in Children and Adolescents, The Fourth Report on the Diagnosis,
Evaluation, and Treatment of High Blood Pressure in Children and Adolescents published
in 2004.
♦
Ages 18 and above: Seventh Report of the Joint National Committee on the Prevention,
Detection, Evaluation, and Treatment of High Blood Pressure published by the National
Institute of Health in 2003.
Systolic blood pressure:
Diastolic blood pressure:
Heart rate:
mmHg
mmHg
beats per minutes
Comments:
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________
_______________________
Signature of data collector
If you have any questions about the information on this form, please see the Local Contact
Sheet.
Print name of data collector
Staff ID:
Appendix C
C.11–10
National Children’s Study: Report of Findings and Referrals
4.
DSMB-Directed Report of Findings
There may be circumstances where test results indicate risk to respondents or communities. In
these cases, the NCS Data Safety and Monitoring Board (DSMB) would be consulted. The DSMB
makes recommendations to the NICHD Director, the NCS Director, and the Ethics Advisory
Committee; Subcommittee of Federal Advisory Committee concerning protocol and operational
issues to ensure the safety of participants and the validity and integrity of the data. It is
particularly involved in emerging results that should be communicated to the study participants
and/or community.
The DSMB will define criteria to be used to reveal findings to affected persons. These criteria will
reflect, among other factors, the time tag between collection of data and analysis, and clinical
relevance of the findings, such as medical recourse to address the expected probability of harm.
These recommendations are reported to the NICHD, any additional study sponsors, the clinical
investigators, any data coordinating centers and the IRBs of participating institutions through an
established information flow.
Five to ten persons independent of the NCS study are appointed by the NICHD director to serve
on this Board. Normally, members are not employees of the NIH or from the same institution as
the Principal Investigator(s).These persons are expected to have experience in longitudinal
epidemiologic studies, ethics, biostatistics, pediatrics, environmental toxicology, data disclosure
and genetics. Staffing for this Board is expected to be complete well in advance of field
operations. The charge, operating procedures, and responsibilities of the NCS DSMB will be the
first task before the Board, and are expected to align closely with those described in the draft
guidance found at http://www.fda.gov/cber/gdlns/clindatmon.pdf.
Should the DSMB determine that test results that otherwise would not have been shared should
be revealed to participants, we would recommend the following implementation approach 1) a
letter indicating that the NCS has some test results that we would like to share with the
respondent would be sent by return receipt to the respondent; 2) a phone call would be placed to
the respondent 2-3 days after shipment to ask if the respondent received the letter, if s/he had
any questions about the contents of the letter, and if s/he would like the test results to be mailed;
3) if the respondent would like test results sent, a letter requiring signature upon delivery would
be sent by FedEx or similar to the respondent; 4) a follow up call would be placed 2-3 days after
expected delivery to discuss the contents of the letter with the respondent and provide referral
Appendix C
C.11–11
National Children’s Study: Report of Findings and Referrals
information as appropriate. Telephone contactors would be specially selected and trained for this
task, including bilingual contactors as needed.
We allow that in some cases, some tracing activity would need to be performed to locate a
respondent, especially in cases of prior study non-response, and in some of these cases, follow
up will not be successful. We will make efforts, however, to minimize this.
Appendix C.12
IRB Certifications
Appendix C
C.12–1
Office of the Clinical Director
National Institute of Child Health
and Human Development
CRC; Room 5-2571
10 Center Drive MSC 1832
Bethesda, Maryland 20892-1832
FAX: 301 402-1073
MEMORANDUM
DATE: June 26, 2008
Peter Scheidt, M.D., MPH
TO:
FROM: Gilman Grave, MD
Through: Stephen G. Kaler, MD MPH
Clinical Director, NICHD
SUBJECT:
Disposition from 06/25/08 NICHD Institutional
Review Board Meeting
Below please find the disposition concerning the review of your protocol considered this
week by the IRB. Thank you very much for submitting this interesting study.
NEW PROTOCOL
National Children’s Study (The findings of the National Academy of Science
Review, and the response to those findings.)
Principal Investigator: Peter Scheidt
Protocol Title: The National Children’s Study – Pilot protocol.
Protocol number: New Application
Discussion and Disposition: The Board was favorably inclined in its
consideration of the National Children’s Study. However, it was understood that
the final protocol and consent procedures were not yet finalized. Therefore, the
Board agreed to table consideration of the protocol pending receipt of the updated
protocol, consent form and the script for the consent video. The vote was 6 in
favor, 1 opposed (the member preferred to defer consideration of the protocol
without a formal vote).
Recommendations:
1.
2.
Provide updated protocol, consent form and script of consent video.
Highlight changes
Provide list of DSMB members (including affiliations) for IRB review and
Revised August 28, 2008
Appendix C
page 2
3.
4.
5.
6.
C.12–2
approval.
Provide a list of ongoing study working group members and affiliations
Provide an update to the IRB on at least a biannual basis.
Provide a plan for addressing health disparities noted in the IOM Report.
Provide a summary of the public comments received on the protocol.
THIS PROTOCOL EXPIRES JUNE 24, 2009
Revised August 28, 2008
Appendix C
C.12–3
TO:
Elaine Eaker and Paul Hurwitz
FROM:
Kerry Levin
Acting Chair, Institutional Review Board
January 29, 2008
SUBJECT:
IRB Review and Approval
National Children Study
Contract No. HHSN275200503395C
Project 8208
FWA5551
_____________________________________________________________________________________
On January 8, 2008, the Westat Institutional Review Board (IRB) conducted its review of the
following: National Children’s Study (NCS), Contract No. HHSN275200503395C, Project 8208. This
review covers all procedures before and during the mother’s pregnancy through the birth visit and the one
month visit. Data collection activities with the mother, father and child after the one month visit will be
presented and addressed at a subsequent IRB meeting. Westat’s IRB reviews all studies involving human
research before activities may begin under 45 CFR pt 46.
Due to the complexity of the study, project staff organized several informational steps to help
familiarize the Board with the goals and objectives of the study prior to a voting decision. First, an
informational session during the December 11th IRB meeting was held. During this meeting, project staff
provided the Board with an overview of the project and presented a sample of the video consent process.
Following this session, the IRB Board Chair circulated a series of questions from Board members to
project staff. The final review of study materials and procedures took place during the January Board
meeting which was also included a discussion of the answers provided to all of the questions and requests
for further clarification regarding answers to some questions.
Following the January Board meeting, additional information was submitted by the NCS project
staff to supplement answers to questions which had been submitted previously. These answers now
appear in the final record and are included as an attachment to the study protocol. Some of the answers
will require modification to the study protocol at a future time. It is anticipated that a copy of the revised
protocol reflecting the answers to questions will be sent to this IRB for the record.
Lastly, even if the protocol does not change, if Westat’s role with regard to data collection should
change, those aspects of the study must be reviewed by the Westat IRB.
The Board determined that NCS presents no greater than minimal risk to the pregnant woman and
their unborn children. It was also determined that the number of ultrasounds being conducted does not
place the women or child at increased risk, based on documentation provided to the Board.
Revised August 28, 2008
Appendix C
C.12–4
Because this study presents no greater than minimal risk, the Board waives the requirement for the
father’s consent for the child or unborn fetus [45 CFR 46.116 of Subpart A and 46.408 (b)]. The father
however, will be required to provide written consent for his own participation in the study. In addition, a
waiver for permission from both parents has been granted for emancipated pregnant minors as long as it
does not conflict with local jurisdiction requirements. Each Study Center will be responsible for
adherence to their local jurisdictional requirements regarding the consent and enrollment of pregnant
minors. The Coordinating Center will prepare procedures to be used when the pregnant minor is legally
allowed to provide consent, and when she is not, and the Study Centers will be required to adhere to their
local laws.
Based upon this approval, the project must submit a Certificate of Confidentiality to the IRB as
soon as it is received; no reference to the Certificate may be made to the women whose consent for
enrollment is sought until the Certificate is obtained.
It is understood that no data collection will begin until approval of the study by the NICHD IRB.
In addition, no data collection will begin at any study center site until the approval of the study, including
all activities of the study center and their subcontractor or organizations, by that Center’s IRB. It is
anticipated that the NICHD agency IRB will serve as the central NCS IRB to review any protocol
changes from the package approved here by the Westat IRB. Any such approvals of changes made by the
NICHD IRB will be transmitted to the Westat IRB for our records and use in oversight of Westat’s
Coordinating Center activities.
In accordance with 45 CFR 46, the Board unanimously approved this study for the phases
submitted, which includes procedures before and during the pregnancy of the mother, up to the birth of
the child.
You are obligated to submit the study for an annual review on or before January 29, 2009. In the
interim, you are responsible for notifying the Office of Research Administration as soon as possible if
there are any injuries to the subjects, problems with the study, or changes to the study design that relate to
human subjects.
cc:
Institutional Review Board
Revised August 28, 2008
Appendix C
C.12–5
TO:
Elaine Eaker and Paul Hurwitz
FROM:
Kerry Levin
Acting Chair, Institutional Review Board
February 11, 2008
SUBJECT:
ADDENDUM to approval letter dated 01-29-08 (CORRECTED)
National Children Study
Contract No. HHSN275200503395C
Project 8208
FWA5551
_____________________________________________________________________________________
On January 29, 2008, the Westat Institutional Review Board (IRB) assigned full approval of the
following: National Children’s Study (NCS), Contract No. HHSN275200503395C, Project 8208. The
approval covered all procedures before and during the mother’s pregnancy through the birth visit and the
one month visit. Data collection activities with the mother, father and child after the one month visit will
be presented and addressed at a subsequent IRB meeting. Westat’s IRB reviews all studies involving
human research before activities may begin under 45 CFR pt 46.
Because this study presents no greater than minimal risk, requests for five waivers of informed
consent were granted by the board. The first three requests described below are waivers for
documentation of informed consent. The remaining two requests are waivers to allow signed informed
consent from only one parent or guardian since the IRB determined that permission of one parent was
sufficient. However, while discussed at the board meeting, explicit descriptions of each waiver were
inadvertently omitted from the approval letter. Therefore, each waiver is listed below:
1.
A waiver of the requirement for documentation of informed consent (obtaining a signed
consent form) for the enumeration stage. This step is designed to locate households
containing potentially eligible women for the Study. IRB regulations permit waiver of
documentation of informed consent when the research presents no more than minimal risk
[45 CFR pt. 46.116 (d) 46.117 (c) (2)].
2.
A waiver of the requirement for documentation of informed consent (obtaining a signed
consent form) for the screening stage. This step is only designed to determine the
eligibility of women for the study. The vast majority of women will not be eligible for the
study. IRB regulations permit waiver of documentation of informed consent when the
research presents no more than minimal risk [45 CFR pt. 46. 116 (d) 46.117 (c) (2)].
3.
A waiver of the requirement to obtain a signed consent form for each specific study visit
after enrollment. The project will obtain signed informed consent at enrollment, using
Revised August 28, 2008
Appendix C
C.12–6
either the video or the paper form, for eligible participants who choose to join the study.
IRB regulations permit waiver of documentation of informed consent when the research
presents no more than minimal risk and participants are provided with written information
regarding the research[45 CFR pt. 46. 116 (d) 46.117 (c)(2)].
4.
A waiver for both parents of the unborn child to sign the consent form for enrollment of
pregnant women and their unborn children into the study. The Board waives the
requirement for the father’s consent for the child or unborn fetus [45 CFR 46.116 of
Subpart A and 46.408 (b)]. The father however, will be required to provide written
consent for his own participation in the study.
5.
A waiver for both parents of pregnant minors to sign the consent form for enrollment of
pregnant minors into the study as long as it does not conflict with local jurisdiction
requirements. 45 CFR Part 46, Subpart D provides for "Additional Protections for Children
Involved as Subjects of Research." The requirement for parental permission may be inappropriate
in some cases. Examples include research involving older adolescents who, under applicable law,
may consent on their own behalf . The Coordinating Center will prepare procedures to be used
when the pregnant minor is legally allowed to provide consent, and when she is not. Each
Study Center will be responsible for adherence to their local jurisdictional requirements
regarding the consent and enrollment of the pregnant minor.
Note: All information included in the approval letter date January 29th, 2008 remains unchanged.
cc:
Institutional Review Board
Revised August 28, 2008
| File Type | application/pdf |
| File Title | Appendix A |
| Author | Duane Walker |
| File Modified | 2008-09-22 |
| File Created | 2008-09-10 |