Appendix C

Appendix C1.pdf

Pilot Study for the National Children's Study (NICHD)

Appendix C

OMB: 0925-0593

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Appendix C
Additional Study Documentation

Appendix C.1
Legal Authority

Appendix C

C.1–1

Children's Health Act of 2000 (Public Law 106-310 Sec. 1004).

Congress authorized the planning and implementation of the National Children’s Study
with the Children's Health Act of 2000 (Public Law 106-310 Sec. 1004).
SEC. 1004. LONG-TERM CHILD DEVELOPMENT STUDY.
(a) PURPOSE—It is the purpose of this section to authorize the National Institute of
Child Health and Human Development to conduct a national longitudinal study of
environmental influences (including physical, chemical, biological, and psychosocial) on
children's health and development.
(b) IN GENERAL—The Director of the National Institute of Child Health and Human
Development shall establish a consortium of representatives from appropriate Federal
agencies (including the Centers for Disease Control and Prevention, the Environmental
Protection Agency) to—
(1) plan, develop, and implement a prospective cohort study, from birth to adulthood, to
evaluate the effects of both chronic and intermittent exposures on child health and human
development; and
(2) investigate basic mechanisms of developmental disorders and environmental factors,
both risk and protective, that influence health and developmental processes.
(c) REQUIREMENT—The study under subsection (b) shall—
(1) incorporate behavioral, emotional, educational, and contextual consequences to
enable a complete assessment of the physical, chemical, biological, and psychosocial
environmental influences on children's well-being;
(2) gather data on environmental influences and outcomes on diverse populations of
children, which may include the consideration of prenatal exposures; and
(3) consider health disparities among children, which may include the consideration of
prenatal exposures.

This page is intentionally blank.

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

This page is intentionally blank.

Appendix C.3
Summary of Data Collection Activities

Appendix C

C.3.1-1

NCS PROTOCOL OVERVIEW AND SUMMARY OF CONTACTS
November 28, 2007
Pre- Pregnancy

P1
Home
Informed Consent/Detailed Visit Information/Medical
Release as Needed
Interviews/Assessments/Questionnaires
In-Person/Phone

Within X
days of
P11

P
1 Month
(Phone)

Pregnancy

P
2 Month
(Phone)

P
4 Month
(Phone)

Self-Administered Questionnaire

T1-1st
(Home)

Within X
T1 - Prior Days of
(Home)
T11

16-17
Weeks
(Phone)

Birth

T2
T3-Prior T3-1st
(Clinic) (Clinic) (Home)2
M

M
M
M

Biospecimen Collection
Pregnancy Tests (self-collected)
Vaginal Swabs
Blood/Buccal Cell 7
Blood Spot (heel and cord)
Urine (self-collected)
Hair
Nails
Cord Blood
Umbilical Cord
Placenta
Meconium
Breast Milk (self-collected)
Saliva (self-collected)

MF
MF

MF
MF
M5

Within X
days of
12 Mo.
Visit1

18 Mos.
(Phone)

24 Mos.
(Phone)

M
MF

MFC

M
M
M

X
X
X
X
X

C
C

X
X
X

M4
M4

M
M

M
M
M
M
M

M
MF

M
M

MF
MF
F

M
M
M

M
C

C
C

C
M
M
C
M
M

M5
M9

M
MF

MC
X9
CC

M9
CC=CHILD'S CHILD CARE LOCATION(S)

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.

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.

A home visit will be conducted at 1 month if certain child measures are not completed at the birth visit.

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).
6
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 collections.
9
Community samples and assessments will be collected at regular intervals throughout this time period. The collections/assessments are not connected to a specific visit.
5

Other
Medical Record/Chart Abstraction
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

3 Months
(Phone)

6 Month Within X
12 Month
days of 6 9 Months
Visit
Visit
1
(Home) Mo. Visit (Phone)
(Home)

M
M

Within X
weeks of
B21

Medical Provider Visit Log

Physical Exam
Anthropometric
Blood Pressure
Ultrasound
Dysmorphology
Physical Exam
Lung Function
Observational Photos
Physical Activity
Hearing Assessment
Vision Assessment
BIA

B2
B1
PreDelivery discharge
(Hospital) (Hospital)
M

Diaries/Medical Visit Logs
Pregnancy Diary

Environmental
Indoor Air
House Dust
Drinking Water
Soil
Visual Assessment
Indoor Air (self-collected)
House Dust (self-collected)

Within X
days of 36 Weeks
(Phone)
T31

Post-natal
1 month
visit if
needed3
(Home)

NCS PROTOCOL OVERVIEW
SUMMARY OF QUESTIONNAIRE AND PSYCHOLOGICAL/DEVELOPMENTAL ASSESSMENTS
January 21, 2008

Appendix C

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)

P
4 Month
(Phone)

T1 - 1st2
(Home)

T1 - Prior
(Home)

Within X
Days of
T11

16-17
Weeks
(Phone)

T2
(Clinic)

C.3.2-1

T3 Prior
(Clinic)

T3 - 1st Within X
36 Weeks
(Home)3 Days of T31 (Phone)
M

B1
Delivery
(Hospital)

B2
Pre-discharge
(Hospital)

Post-Natal

Within X
Weeks of
B21

1-Month Visit
4
if Needed
(Home)

3 Months
(Phone)

6-Month
Visit
(Home)

Within X Days 9 Months
of 6-Mo. Visit 1 (Phone)

12-Month
Visit
(Home)

Within X
Days of 12Mo. Visit 1

18 Mos.
(Phone)

24 Mos.
(Phone)

Interview/Assessments
Household Composition and Demographics
Household Composition

Age, race, ethnicity, relationship, marital status

Education

Income (acasi)

Supported by family income (acasi)

Food security

Health insurance

Social status

M
M

Religious affiliation
Culture and acculturation
Contact and Tracing

Perceived Stress
Global Perceived Stress

Racism/Discrimination

Life Events (self-administered)

Parenting Stress

Work/Family Stress

Social Support

Family Process
Quality of Relationships

Domestic Violence (acasi)

Division of Labor

Health Behaviors (maternal)
Physical Activity

Maternal Sleep

Douching (acasi)
Caffeine Use

Tobacco Use (acasi)

Environmental Tobacco Smoke Exposure (acasi)

Alcohol Use (acasi)

Binge Drinking (acasi)
Illicit Drug Use and Abuse of Prescription Drugs (acasi)

Diet and Toxicant Exposure through Food (mother)
- Food Frequency Questionnaire (self-administered questionnaire)

- 3-Day Checklist (self-administered questionnaire)

Diet and Toxicant Exposures through Food (child)
- Child Feeding Form (mailed self-administered questionnaire)

- Child FFQ (mailed self-administered questionnaire)

- Child 3-day Checklist (mailed self-administered questionnaire)

Mental Health & Cognition
Depression

State Trait Anxiety
IQ

Literacy
Mental Health (CIDI Screener)
Maternal / Paternal Attachment

DRAFT

F
M
F

M
F

F
F

DRAFT

NCS PROTOCOL OVERVIEW
SUMMARY OF QUESTIONNAIRE AND PSYCHOLOGICAL/DEVELOPMENTAL ASSESSMENTS
January 21, 2008

Appendix C

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)

Within X
Days of
T11

16-17
Weeks
(Phone)

T2
(Clinic)

C.3.2-2

Birth
T3 Prior
(Clinic)

T3 - 1st Within X
36 Weeks
(Home)3 Days of T31 (Phone)

B1
Delivery
(Hospital)

B2
Pre-discharge
(Hospital)

Within X
Weeks of
B21

Post-Natal
1-Month Visit
4
if Needed
(Home)

Child Care

3 Months
(Phone)

6-Month
Visit
(Home)

Within X Days 9 Months
of 6-Mo. Visit 1 (Phone)
M

12-Month
Visit
(Home)

Within X
Days of 12Mo. Visit 1

18 Mos.
(Phone)

24 Mos.
(Phone)

Neighborhood
M

Financial Security and Program Participation
Housing Characteristics/In home exposures
Occupational/Hobby Exposures

Take Home (Occupational) Exposures
Commuting

M
F5

Pets and Pesticide Use

Use of Medicines (mother)

M
M

Product Use Questionnaire

Use of Medicines (child)
M

Time and Activity (mother) (self-administered questionnaire)

M
M

Time and Activity (child)

Medical History (maternal/paternal)
Current Pregnancy Information

Use of Fertility Services

Biological Father Information

Prenatal Care, Doctor Visits, Hospitalizations

Birth History

M
M

Pregnancy and Reproductive History (acasi)

M
M

Dental Health

Health Status/Functional Limitations/Impairment

Medical History and Conditions

Family Medical History (self-administered questionnaire)

M
M

Medical History (child)
Persistent crying/Colic

Developmental milestones

M
M

Parenting Practices/Behaviors and Media Exposure

Major life events
Future Plans for Child (feeding, sleeping, living arrangements)

M
M

Child Language Development
M

Child Temperament / Emotional Regulation

M
M

Child Socio-Emotional Functioning / Behavior
M

Child Social Competence
Child Autism Screening

Child Adaptive Behavior

Neurobehavioral Assessments
Neonatal Neurobehavior

General Cognitive Ability

General Motor Development

Language Development
Parent-Child Interaction
KEY: M=MOTHER

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.

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.

This visit is only conducted if certain child measures are not completed at the B2 (pre-discharge) visit.
A self-administered questionnaires will be mailed to the respondent to complete. These topics will not be included in the phone interview.

DRAFT

F=FATHER C=CHILD

C
MC

DRAFT

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

43 mL
(5 tubes)

53 mL
(6 tubes)

67 mL
(8 tubes)

40 mL

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 (mL)

33 mL
(4 tubes)

**P1 study participants will be asked to collect a urine sample
the morning after their positive pregnancy test.

Vaginal Swabs (3 swabs)

Hair (~20 strands)

Nails (clippings from all teos)

Saliva (3 collections per day for 2 days)

X
68 mL
(9 tubes)

Cord Blood
Placenta and Umbilical Cord (size measurements,
weight, photographs, tissue blocks, tissue samples)

Breast Milk (mL)
***A Breast Milk kit will be given at the birth visit and milk will be
collected at 1 and 3 months 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

Paternal
Blood

33 mL
(4 tubes)

Urine

Hair (~20 strands)

Nails (clippings from all teos)

Saliva (3 collections per day for 2 days)

Child
Heel Stick (5 spots per Guthrie Card)

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

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)

Hemoglobin/calculated hematocrit

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

Hemoglobin/calculated hematocrit

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

Nutritional analytes (e.g. antioxidants, lipids, carbohydrates, endogenous compounds )
Phytoestrogens and other hormones
Perchlorate, iodide, thiocynate, nitrate
Metals (maganese 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)

C.3.3-2

Appendix C

C.3.4-1

DRAFT

NCS PROTOCOL SUMMARY OF ENVIRONMENTAL SAMPLES BY CONTACT (FOR THE SAME HOME)
DRAFT -- 9/19/2007
Pre- Pregnancy

Indoor Air

Pregnancy

P1 Home

Within X
days of
P1

T1 - 1st
(Home)

T1 - Prior
Within X
Within X Birth Visit
(Home) Days of T1 T3 (Clinic) Days of T3 (Hospital)

Method

% Homes

PM2.5 - metals (XRF); total carbon (reflectance)
(filter to be archived after weighing)1

Pump

100

VOCs (Note: 10% subsample in pilot)

Badge

10 (pilot)

Carbonyls (Aldehydes & Ketones)

Badge

100

NO2 (Trigger: unvented flame source, e.g.,
cookstove, space heater, present, plus 2-3% without
source)

Badge

Allergens, endotoxin (to be archived)

Vacuum

100

Mold (to be archived)

Vacuum
Wipe

100
100

Plate

100

SVOCs (wipe to be archived)

Wipe

100

Pesticides: Pyrethroids (composite, store P1 wipes
for 3 mos to determine pregnancy)

Wipe

100

Water

1+ per
segment/
system/ year

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)

Drinking Water

X
X

Birth

12 Month
Visit
(Home)

X, PU

24 Months
(Phone)

X, PU

Return

X, PU

5
X , return

Return

X, PU

X , return

X, PU

X
X

X 3,5

Post-natal
6 Month
Visit
(Home)

X 5, return

Return after
birth

X 5, return

Disinfection Byproducts (DBPs) - HAA9, THMs
VOCs (pilot)
Soil
Composited play area soil (to be archived)

Water

Soil

12 (pilot)

100 (1 per
structure)

Visual Assessment - Indoor, outdoor 4

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.

Where private wells provide tap water.

Deploy plate at T3 contact (self collection) and mail back at 1-month.

Some observational data will be gathered by neighborhood drive arounds / extant data sources.

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.

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)

H-3

Appendix C

C.3.5-1
Contact Schedule Physcial Measures 1-16-08

Pre- Pregnancy

Physical Measures
Anthropometric Measures
Maternal Weight (2 measures)
Maternal Standing Height (2)
Maternal Sitting Height (2
Maternal Mid Arm Circumference (2)
Maternal Hip Circumference (2)
Maternal Waist Circumference (2)
Maternal Head Circumference (2)
Maternal Triceps Fold (2)
Maternal Subscapular Skin Fold (2)

P1 Home
X
X
X
X
X
X
X

Paternal Weight (2)
Paternal Standing Height (2)
Paternal Sitting Height (2)
Paternal Mid Arm Circumference (2)
Paternal Hip Circumference (2)
Paternal Waist Circumference (2)
Paternal Head Circumfereence (2)
Paternal Triceps Fold (2)
Paternal Subscapular Skin Fold (2)
Infant Recumbant Length (2)
Child Height (2)
Infant/Child Weight (2)
Infant/Child Head Circumference (2)
Infant/Child Mid Upper Arm Circumference (2)
Infant/Child Abdomen Circumference (2)
Infant/Child Thigh Circumference (2)
Infant/Child Triceps Skin Fold (2)
Infant/Child Subscapular Skin Fold (2)
Blood Pressure
Maternal Blood Pressure
Paternal Blood Pressure
Infant/Child Blood Pressure
Maternal/Fetal Ultrasound
Crown rump length
Gestational age
Cardiac activity
Presentation
Biparietal Diameter (BPD)
Head circumference (HC)
Abdominal circumference (AC)
Leg measured: (for FL, MTC, MTLC, MTA, MTLMA)
. Femur length (FL)
Mid thigh circumference (MTC)
Mid thigh lean mass circumference (MTLMC)
Mid thigh total area (MTA) (calculated
Mid thigh lean mass area (MTLMA
Abdominal wall thickness (AWT)
Gender
For Multiple Fetuses (in addition to above measures)
Chorionicity
Amnionicity
Position of each fetus
Estimated fetal weight
Location of placenta
Membranes
Infant Dysmorphology
2-D Images
Face-frontal
Face-profile (right)
Face-profile (left)
Anogenital Distnce Measures
Anterior penis to anus (AGD1)
Posterior base of penis to anus (AGD2)
Posterior of scrotum/fourchette to anus (AGD3)
Surveillance methodology (no participant burden)
Chart Abstraction - Prenatal, Labor, & Delivery
Prenatal care
Prenatal labs
Ultrasound findings
Complications
Prenatal procedures
Admission information
Labor information
Delivery information
Analgesia received in labor
Medications
Chart Abstraction - Neonatal
Delivery information
Post delivery information
Compilcation during hospitalization
Major congenital malformations
Medications during hospital stay
Oxygen/asssisted ventilation
Immunization
Circumcision
Screening Tests
Transfer information
Discahrge weight
Discharge information
Expired
Infant Physical Exam
2-D Images (for atopic dermatitis/eczema)
Face-frontal
Face-profile (right)
Face-profile (left)
Both hands (dorsal view)
Both ears
Both knees (popliteal fossa
Both feet (dorsal view)

Within X
Days of
P11

P
1 Month
(Phone)

P
2 Month
(Phone)

Pregnancy
P
4 Month
(Phone)

Within X
Days of
T11

16 - 17 Weeks
(Phone)

Birth

T1 - 1st
(Home)

T1 - Prior
(Home)

X
X
X
X

X
X

X
X
X

X
X

X
X
X
X
X
X
X
X
X

T3 (Clinic)

Within X
Days of
T2/T3 1

36 Weeks
(Phone)

B1
Delivery
(Hospital)

B2
Pre-discharge
(Hospital)

X
X
X
X
X
X
X

X
X

x
x

Post-Natal

1 Month Visit
Within X weeks of if Needed2
1
(Home)
B2

3 Months
(Phone)

6 Month
Visit
(Home)

Within X
Days of 6
Mo. Visit1

9 Months
(Phone)

Within X Days
12 Month
Visit (Home) of 12 Mo. Visit1

X
X
X
X
X
X

X
X
X
X
X
X
X

X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X

18 Mos.
(Phone)

24 Mos.
(Phone)

Appendix C

C.3.5-2
Contact Schedule Physcial Measures 1-16-08

Pre- Pregnancy

Physical Measures
Anthropometric Measures
Maternal Weight (2 measures)
Maternal Standing Height (2)
Maternal Sitting Height (2)
Maternal Mid Arm Circumference (2)
Maternal Hip Circumference (2)
Maternal Waist Circumference (2)
Maternal Head Circumference (2)
Maternal Triceps Fold (2)
Maternal Subscapular Skin Fold (2)

P1 Home
X
X
X
X
X
X
X

Paternal Weight (2)
Paternal Standing Height (2)
Paternal Sitting Height (2)
Paternal Mid Arm Circumference (2)
Paternal Hip Circumference (2)
Paternal Waist Circumference (2)
Paternal Head Circumfereence (2)
Paternal Triceps Fold (2)
Paternal Subscapular Skin Fold (2)
Infant Recumbant Length (2)
Child Height (2)
Infant/Child Weight (2)
Infant/Child Head Circumference (2)
Infant/Child Mid Upper Arm Circumference (2)
Infant/Child Abdomen Circumference (2)
Infant/Child Triceps Skin Fold (2)
Infant/Child Subscapular Skin Fold (2)
Blood Pressure
Maternal Blood Pressure
Paternal Blood Pressure
Infant/Child Blood Pressure
Maternal/Fetal Ultrasound
Crown rump length
Gestational age
Cardiac activity
Presentation
Biparietal Diameter (BPD)
Head circumference (HC)
Abdominal circumference (AC)
Leg measured: (for FL, MTC, MTLC, MTA, MTLMA)
. Femur length (FL)
Mid thigh circumference (MTC)
Mid thigh lean mass circumference (MTLMC)
Mid thigh total area (MTA) (calculated)
Mid thigh lean mass area (MTLMA)
Abdominal wall thickness (AWT)
Gender
For Multiple Fetuses (in addition to above measures)
Chorionicity
Amnionicity
Position of each fetus
Estimated fetal weight
Location of placenta
Membranes
Infant Dysmorphology
2-D Images
Face-frontal
Face-profile (right)
Face-profile (left)
Anogenital Distnce Measures
Anterior penis to anus (AGD1)
Posterior base of penis to anus (AGD2)
Posterior of scrotum/fourchette to anus (AGD3)
Surveillance methodology (no participant burden)
Infant Physical Exam
2-D Images (for atopic dermatitis/eczema)
Face-frontal
Face-profile (right)
Face-profile (left)
Both hands (dorsal view)
Both ears
Both knees (popliteal fossa
Both feet (dorsal view)
Chart abstraction - Prenatal, Labor & Delivery
Prenatal care
Prenatal labs
Ultrasound findings
Complications
Prenatal procedures
Admission information
Labor information
Delivery information
Analgesia received in labor
Medications
Chart abstraction - Neonatal
Delivery information
Post delivery information
Compilcation during hospitalization
Major congenital malformations
Medications during hospital stay
Oxygen/asssisted ventilation
Immunization
Circumcision
Screening Tests
Transfer information
Discahrge weight
Discharge information
Expired
Bioelectrical Impedance Analysis
BIA
Hearing Assessment
Audiometry
Vision Assessment
Acuity
Lung Function
Measure of lung function
DXA
Under consideration (possible adjunct study)
Bone Ultrasound
Under consideration
Physical Activity
Accelerometer (under consideration)
Time-Activity Diary

Within X
days of
P1 1

P
1 Month
(Phone)

P
2 Month
(Phone)

Pregnancy
P
4 Month
(Phone)

Within X
Days of
T1 1

Birth

T1-1st
(Home)

T1 - Prior
(Home)

X
X
X
X

X
X

X
X
X

X
X

X
X
X
X
X
X
X
X
X

16-17 Weeks
(Phone)

T3 (Clinic)

Within X
days of
T2/T3 1

36 Weeks
(Phone)

B1
Delivery
(Hospital)

B2
Pre-discharge
(Hospital)

X
X
X
X
X
X

X
X

x
x

Post-Natal

1 month visit
Within X weeks of if needed 2
B2 1
(Home)

3 Months
(Phone)

6 Month
Visit
(Home)

Within X
days of 6
Mo. Visit 1

9 Months
(Phone)

Within X days
12 Month
Visit (Home) of 12 Mo. Visit 1

18 Mos.
(Phone)

24 Mos.
(Phone)

30 Mos.
(Phone)

36 Month Visit Within X days of
(Clinic)
36 Month Visit 1

X
X
X
X
X

X
X
X
X
X
X

X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X

X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
X
??
??
??
??

Appendix C

C.3.6–1

Initial Pregnancy Screener Algorithm 1.10.08
Collect/ Confirm Age?*

R who previously reported herself pregnant at
Enumeration or Proxy interviews for <18 who
was reported pregnant at Enumeration.
Yes, Currently or
Probably Pregnant**

Currently Pregnant?*/
Probably Pregnant?

Age 18-49 and No to Currently or
Probably Pregnant, or RF/DK to
Probably Pregnant

Due Date/ Date of
LMP/ Weeks
Pregnant/ Months
Pregnant/ Current
Trimester?

Currently
Trying?

Number of
months
trying?

Yes, and due date between
first and last eligible due dates***

Pregnant Eligible
Group
(T1 Visit if <28 weeks
pregnant or T3 First Visit
if 28 or more weeks
pregnant)

Yes, and 18-49 and
due date before first eligible
due date (per segment) OR
No Longer Pregnant***
Holding Group
(Recontact 6
mos. after Due
Date)

Yes, and under 18 or > 49 and due
date before first eligible due date (per
segment) OR under 18 or >49 and No Longer
Pregnant**** OR all ages and due date
after last eligible due date (per segment)***

No Follow up
Group

<5 months
and age 18-49

High Group
(P1Visit)

Trying 5-11 months
and age 18-34

Moderate/Low
Group+
(Will receive
call in 3
months)

Yes

No or RF/ DK

Trying 12 or more
Yes, R surgically
months and age 18-49
sterile or had menopause
OR trying 5-11 months
and age 35-49 OR RF/DK
No Follow
Up Group
Extra Low
Group+
(Will call in
6 months)

R surgically
sterile or had
menopause?

No, and Age 45-49

No, and Age 18-44
OR RF/DK

Extra Low
Group+
(Will call in 6
months)

Sex with male
in past 3
months?

+The Moderate/Low Group may also be referred to as the Moderate Group and the Extra Low Group may be referred to as the Low Group.
*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 18-49 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.

Yes

No or RF/ DK

Partner had a
vasectomy?

Extra Low Group+
(Will call in 6 months)

No, Not Sure or RF

Yes

Doing anything
to prevent
pregnancy?

Extra Low Group+
(Will call in 6 monhts)

***First and last eligible due dates are based on the dates that recruiting starts and ends in each segment.
****Women under 18 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.
All women who fall into the Pregnant Eligible and High groups are asked about their plans to move including where they will move and when. If a woman
responds that she is moving (before her baby is born or within 2 months if in high 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.
The algorithm will calculate PPG at the initial pregnancy screener based on the R'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 technically has turned 50. Otherwise, if the R will be 50 at the next contact, she will instead be assigned to the No-Follow Up group.

No, and 35-44 or RF/DK
Moderate/Low
Group+
(Will receive
call in 3 months)

Yes
Contraceptive
type?

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 18-29 OR
using withdrawal or natural
family planning and 35-44

Extra Low
Group+
(Will call in 6
months)

Moderate/ Low
Group+
(Will receive call
in 3 months)

No, and 18-34

High Group
( P1 Visit)

Using withdrawal or
natural family planning
and 18-34

High Group
(P1Visit)

Appendix C

C.3.6–2

Follow Up Algorithm: P1, P2 and P4 Month Calls - 1.10.08
High Group 2 No Contraception
(Women not trying and
not using contraception
ages 18-34)

High Group 1 - Trying to Become Pregnant
(Women trying to become pregnant, ages 18-49
and trying 4 or less months)

Intro to P1/P2/P4 Month: I'm calling today
just to update some information we have
for you. Last time we spoke, you weren't
trying to become pregnant, but we know
that plans to start a family can sometimes
change.

was Intro
reported
pregnantMonth:
at Enumeration.
to P1/P2/P4
I'm calling today just to
update some information we have for you.

Yes

Learned
Pregnant?

Due date/ First day
of last menstrual
period/ Weeks
pregnant?

High Group 3 High Failure Rate Contraception
(Women not trying and using
contraception with high failure rate ages
18-34)

Are you now trying to
become pregnant?

Yes
Learned
pregnant?

Still
Trying?

Doing anything
to prevent
pregnancy?

Currently
Pregnant

No
High Group
(Continue calls through P4 - then move to
Moderate/Low Group)

Eligible Due Date

Yes

Ineligible Due Date

No, and 35-44

Inform will mail pregnancy test kits
Pregnant Eligible
Group
(T1 Visit if <28 weeks
pregnant or T3 First
Visit if 28 or more
weeks pregnant)

Congratulations
again on your
pregnancy. Because
you're pregnant,
we'd like to set up a
visit at your home to
tell you about the
next phase of this
study.

Holding Group
(Recontact
6 mos. after
Due Date)

Congratulations again on your
pregnancy. While this study
focuses on child health, at this
time we are only enrolling
women whose babies are due
between (DATE 1) and (DATE
2).** However, if you become
pregnant again, that baby may
be eligible for the study later on.
We'll check in with you a few
months after your baby is born
to see how you're doing and
update your information.

Yes, and trying
4 months or less
(calculated from
start of P1
Month call)

High Group
(Continue calls through
P4 - then move to
Moderate/Low Group)

Need More
Pregnancy
Test Kits?

We'll call you in a
month or two to see
if anything has
changed. In the
meantime, if you
learn that you're
pregnant, please
[insert local
procedures].

We'll call you in a month or two to see if anything
has changed. In the meantime, if you learn that
you're pregnant, please [insert local procedures].
No, or Yes and
trying more than
4 months (calculated
from start of P1 Month
call)
Moderate/Low
Group+
(Call in 3 months)***

Yes, trying
Need More
Pregnancy
Test Kits?

We'll call you in a
month or two to
see if anything has
changed. In the
meantime, if you
learn that you're
pregnant, please
[insert local
procedures].

No, not
trying

Due date/ First day
of last menstrual
period/ Weeks
pregnant?

Moderate/Low
Group+
(Will receive call in 3
months)***

Eligible Due Date

Ineligible Due Date

Pregnant
Eligible Group
(T1 Visit)

Holding Group
(Recontact
6 mos. after
Due Date)

Congratulations again on your
pregnancy. Because you're
pregnant, we'd like to set up a visit
at your home to tell you about the
next phase of this study.

Congratulations again on your
pregnancy. While this study
focuses on child health, at this
time we are only enrolling
women whose babies are due
between (DATE 1) and (DATE
2).** However, if you become
pregnant again, that baby may
be eligible for the study later on.
We'll check back with you a few
months after your baby is born
to see how you're doing and
update your information.

We understand that
plans can change and
that you're not trying
to become pregnant
right now. We'll call
you in a month or two
to check in with you
and see if anything
has changed.

.
+The Moderate/Low Group may also be referred to as the Moderate Group and the Extra Low
Group may be referred to as the Low Group.
*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.
**(Date 1) and (Date 2) are the segment-specific first eligible due date and last eligible due date.
***The Moderate/Low Group will receive a total of 3 calls (1 every 3 months) before they are moved to the Extra Low Group.

The algorithm will calculate PPG based on the R'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 technically reached age 50. For those that would fall into the Moderate/Low, Extra Low or Holding Group, however,if the algorithm calculates the R
would be 50 at the next scheduled follow up phone call, they will instead be assigned to the No Follow Up group.

Yes

No, and 18-34

High Group
(Continue calls
through P4 - then move
to Moderate/Low
Group)

Contraceptive
type?

We'll call you in a month or two to
check in with you and see if
anything has changed.

Using method other than
Using method other than
withdrawal and natural
withdrawal and natural family
family planning and age 30-44 planning and age 18-29 OR
using withdrawal or natural
family planning and 35-44
Extra Low
Group+
(Will call in 6
Moderate/ Low
months)
Group+
(Will receive call
in 3 months)***

We'll call you in about six months to
check in with you and update your
information.

We'll call you in a month or two to
check in with you and see if
anything has changed.

Using withdrawal or natural
family planning and age 18-34
High Group
(Continue calls through P4 then move to Moderate/Low
Group)

We'll call you in a month or two to
check in with you and see if
anything has changed.

Appendix C

C.3.6–3

Moderate/Low Pregnancy Probability Group Call 1.10.08+
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 18-29 OR using withdrawal or
natural family planning and 35-44)

Previously reported trying to get pregnant
(trying 5-11 months and age 18-34 or trying
more than 4 months from High PPG)

Are you now
trying to become
pregnant?

Pregnant?

Not trying to become
pregnant
No and
DK/RF

Still trying?

Has R had
three
Mod/Low PPG
calls?

Moderate/
Low
Group*+

Yes

Extra Low
Group*+

Yes or Probably
Pregnant**

Recently lost
pregnancy, age 18-49
and 9 months or less
remaining before last
Recently lost
eligible due date
pregnancy,
OR recently lost
age 18-49
pregnancy and >49.
and more than
9 months remaining
before last
eligible due date.
No Follow

Trying to become
pregnant

Currently Pregnant

Sex with male
last 3 months?

Has R had
four months
in High
PPG calls?

Due Date/ Date
of LMP/ Weeks
Pregnant?

Yes

Extra Low
Group+
No

Doing anything
to prevent
pregnancy?

Yes

up Group

Holding
Group
(Recontact
in 6 mos.)

Eligible
due date***

Pregnant Eligible
Group
(T1 Visit if <28 weeks
pregnant or T3 First
Visit if 28 or more
weeks pregnant)

R's due date is after last
eligible due date
(R will not deliver before
last eligible due date)***

High Group*

Age 18-34 and
No or RF/DK

Moderate/ Low
or Next
Appropriate
Group*+

No Follow
up Group

Yes
Age 35-44 and
No or RF/DK

Has R had
four months
in High
PPG calls?

No
No

**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.
All women who fall into the Pregnant Eligible and High groups are asked about their plans to move including where they will move and when. If a
woman responds that she is moving (before her baby is born or within 2 months if in high 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.
Women who move between the high 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.
The algorithm will calculate PPG based on the R's current age. For those that are 49, however, the algorithm will calculate whether the R would
be 50 at the next scheduled follow up phone call. If so, the R will instead be assigned to the No-Follow Up group.

High Group*

Yes

+The Moderate/Low Group may also be referred to as the Moderate Group and the Extra Low Group may be referred to as the Low Group.
*The Moderate/Low Phone Call algorithm requires the incorporation of data on how long the R has spent in each PPG. The R can spend up to a
total of four months in the High PPG before being assigned to the Moderate/Low PPG and up to a total of nine months in the Moderate/Low PPG
before being assigned to the Extra Low PPG. The R can spend up to the entire recruitment period in the extra low group, which receives phone
calls once every six months. The R can also move back up to the Moderate/Low PPG and between the Moderate/Low PPG and Extra Low PPG
groups based on the combination of their questionnaire answers and PPG history. The amount of time allowed in the High PPG resets after the
birth of a new baby or the loss of a pregnancy.

Contraceptive
type?

Has R had
three
Mod/Low
PPG calls?

Moderate/ Low
or Next
Appropriate
Group*+

Moderate/
Low
Group*+

Extra Low
Group*+

Using method other
than withdrawal or natural
family planning and 30-44
OR RF/ DK

Extra Low
Group*+

Using method other
than withdrawal or natural
Using withdrawal or
family planning and 18-29 OR
natural family planning
using withdrawal or natural
and 18-34
family planning and 35-44

Moderate/ Low/
Next
Appropriate
Group*+

High / Next
Appropriate
Group*

Appendix C

C.3.6–4

Extra Low Call Algorithm 01.10.08+
Introduction for All Calls:
It's been about six months since someone from the National Children's Study has spoken with you and
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
(T1 Visit if <28 weeks
pregnant or T3 First Visit if 28
or more weeks pregnant)

No, probably not pregnant

Yes

Number of
months
trying?

Due date after last eligible
due date***

No Follow up
Group

<5 months
and age 18-49

High Group/ Next
Appropriate
Group*

Trying 5-11 months
and age 18-34

Moderate/Low
Group*+
(Will receive
call in 3
months)

Trying 12 or more
months and age 18-49
OR trying 5-11 months
and age 35-49 OR RF/DK

No, or RF/DK

R surgically
sterile or had
menopause?

Yes, R surgically
sterile or had menopause

No, and Age 45-49

No, and Age 18-44
OR RF/DK

No Follow
Up Group

Extra Low
Group+
(Will call in 6
months)

Sex with male
in past 3
months?

Extra Low
Group+
(Will call in
6 months)

Yes

No or RF/ DK

Partner had a
vasectomy?

Extra Low Group+
(Will call in 6 months)

No, Not Sure or RF

Yes

Doing anything
to prevent
pregnancy?

Extra Low Group+
(Will call in 6 monhts)

+The Moderate/Low Group may also be referred to as the Moderate Group and the Extra Low Group will also be referred to as the Low Group.
*The Extra Low Phone Call algorithm requires the incorporation of data on how long the R has spent in each PPG. The R can spend up to a total of four months in the High PPG
before being assigned to the Moderate/Low PPG and up to a total of nine months in the Moderate/Low PPG before being assigned to the Extra Low PPG. The R can spend up to
the entire recruitment period in the extra low group, which receives phone calls once every six months. The R can also move back up to the Moderate/Low PPG and between the
Moderate/Low PPG and Extra Low PPG groups based on the combination of their questionnaire answers and PPG history. The amount of time allowed in the High PPG resets
after the birth of a new baby or the loss of a pregnancy.
Women who move between the high and any other group will be given a P1 only once per year.
**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.
All women who fall into the Pregnant Eligible and High groups are asked about their plans to move including where they will move and when. If a woman responds that she is
moving (before her baby is born or within 2 months if in high 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.
The algorithm will calculate PPG based on the R's current age. For those that are 49, however, the algorithm will calculate whether the R would be 50 at the next scheduled follow
up phone call. If so, the R will instead be assigned to the No-Follow Up group.

No, and 35-44 or RF/DK
Moderate/Low
Group*+
(Will receive
call in 3 months)

Yes
Contraceptive
type?

No, and 18-34
High 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 18-29 OR
using withdrawal or natural
family planning and 35-44

Using withdrawal or
natural family planning
and 18-34

Extra Low
Group+
(Will call in 6
months)

Moderate/ Low
Group*+
(Will receive call
in 3 months)

High Group/
Next
Appropriate
Group*

If the respondent's PPG assignment would put the next contact after the end of the recruitment period, the respondent will be assigned to the No Follow Up Group.

Appendix C.4
60-Day Federal Register Notice

Appendix C

Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices

C.4–1
65049

ANNUALIZED BURDEN TABLE
Type of
respondents

Estimated number
of respondents

Average burden
per response

Estimated total
annual burden
hours requested

Asthma grantee survey ....................................................

1550

.25

387.5

Total ..........................................................................

................................

387.5

Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs, New Executive
Office Building, Room 10235,
Washington, DC 20503, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Jerry
Phelps, Division of Extramural Research
and Training, National Institute of
Environmental Health Sciences, P.O.
Box 12233, MD EC–21, 111 T.W.
Alexander Drive, RTP, NC 27709. Phone
(919) 541–4259. E-mail:
[email protected].
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
rwilkins on PROD1PC63 with NOTICES

Estimated number
of responses
per respondent

Dated: November 7, 2007.
Marc Hollander,
NIEHS, Associate Director for Management.
[FR Doc. E7–22594 Filed 11–16–07; 8:45 am]
BILLING CODE 4140–01–P

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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Child Health and
Human Development; Proposed
Collection; Comment Request; Pilot
Study for the National Children’s Study
In compliance with the
requirement of section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
National Institute of Child Health and
Human Development (NICHD), the
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
Proposed Collection: Title: Pilot Study
for the National Children’s Study, Type
of Information Collection Request:
NEW, Affected entities: Households and
individuals. Types of respondents:
People potentially affected by this
action are pregnant women, women age
18–49 years of age, their husbands or
partners, and their children who live in
selected areas within the seven (7)
National Children’s Study Vanguard
sites enumerated below. A small
number of health care professionals,
community leaders, and child care
personnel are also potential
respondents. Frequency of Response: On
occasion. See burden table for estimated
number of annual responses for each
respondent. Need and use of
information collection: The purpose of
this Study is to pilot test protocols,
policies, and procedures for the
National Children’s Study (NCS) with
the goal of improving the efficiency of
study procedures and enhancing the
subsequent implementation of the NCS.
The NCS is a long-term cohort study of
environmental influences on child
health and development authorized
under the Children’s Health Act of 2000.
The Act specifies a broad definition of
environment, including biologic,
chemical, physical, and psycho-social
factors and authorizes NICHD to plan,
develop, and implement a prospective
cohort study, from birth to adulthood, to
evaluate the effects of those exposures

SUMMARY:

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on child health and human
development. This data collection will
test procedures for population-based
sampling and recruitment of pregnant
women and women of child-bearing age,
test study logistics, and estimates of
subject burden, and evaluate data
collection strategies including
interviews and acquisition of biologic
and environmental samples. In addition,
participants will also be asked to
provide qualitative and quantitative
input on their feelings regarding
participation in this Study, to enhance
the lessons that can be learned and
applied to improve the efficiency of the
full NCS. Further details pertaining to
the NCS background and planning,
including the NCS Research Plan, can
be found at: http://
nationalchildrensstudy.gov. This Pilot
Study will be carried out in the seven
NCS ‘‘Vanguard’’ locations previously
selected as the initial study sites. These
sites are Orange County, CA; Duplin
County, NC; Queens County, NY;
Montgomery County, PA; Salt Lake
County, UT; Waukesha County, WI; and
the aggregate of Lincoln, Pipestone, and
Yellow Medicine Counties, MN and
Brookings County, SD. This data
collection is intended to begin with
household enumeration and enrollment
of women, proceed through pregnancy
and birth, and continue with follow-up
of children for up to 21 years. This
application is for the first three years of
data collection, which includes data
collection through the visits at which
some of the children will be 24 months
old. Details of data collections beyond
this period will be addressed at the time
of renewal or in future applications.
Women who are pregnant will be
eligible for participation if, at the time
of household enumeration and
screening, they are within the first
trimester of pregnancy. Women who are
not pregnant will be eligible if, at the
time of household enumeration and
screening, they are 18–49 years of age,
are neither surgically nor medically
sterile, and can participate in the
consent process. A subset of age-eligible
women with a high likelihood of
pregnancy (e.g., planning to become
pregnant) will be enrolled to enable
assessment of peri-conceptional

E:\FR\FM\19NON1.SGM

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Appendix C
65050

C.4–2
Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices

exposures, should they become
pregnant. The remainder of the study
population will comprise women
enrolled early in pregnancy. The seven
centers combined will follow
approximately 1000 infants born to
women enrolled in the first year of this
Pilot Study. Infants born to women
enrolled in this Pilot Study but born
after the eligibility period for the Pilot
will be eligible for enrollment in the full
NCS. The schedule of participant
contacts for this data collection includes
home visits, clinic visits, and phone
contacts, and is described in the NCS
Research Plan: http://
nationalchildrensstudy.gov. Home visits
before and during pregnancy will
include collection of interview data,

environmental specimens such as air
and dust samples, maternal and paternal
biospecimens such as blood and hair
samples, and a brief physical
examination including anthropometric
measures and blood pressure. During
pregnancy, women will receive up to
three fetal ultrasounds to assess fetal
growth. At birth, cord blood and
placental samples will be collected and
the infant will receive a brief
developmental assessment. During
infancy, home visits will include
collection of interview data,
environmental specimens, biospecimens
from the infant and parents, a brief
physical examination of the infant, and
assessment of infant development and
parental-infant interactions. Burden

statement: The public burden for this
Study will vary depending on the
eligibility and pregnancy status of
potential participants at the time of
household screening. Women who are
not pregnant at the time of screening
will have varying burden depending on
their likelihood of pregnancy and,
should they become pregnant, the time
to pregnancy. The burden for women
enrolled during pregnancy will depend
on when during pregnancy they are
identified and enrolled in the Study.
The table provides an annualized
average burden per person for each stage
of the Pilot Study over the three year
period of the Study.

ESTIMATED AVERAGE ANNUAL BURDEN FOR PILOT STUDY FOR NATIONAL CHILDREN’S STUDY, BASED ON THREE YEAR
TOTALS
Estimated
number of
responses per
respondent

Estimated
number of
respondents

Types of respondents (estimated hourly rate)

Household activities ($12/hr):
Household enumeration ...........................................................
Eligibility screening ...................................................................
Preconception activities ($12/hr):
High probability women ............................................................
Moderate prob, women ............................................................
Low probability women .............................................................
Pregnancy activities—women ($12/hr) .....................................
Birth activities—mothers & children ($12/hr) ............................
Postnatal activities—mothers & children ($12/hr) ....................
Fathers ($12/hr) ........................................................................
Health care providers ($90/hr) ..................................................
Community leaders ($75/hr) .....................................................
Child care providers ($25/hr) ....................................................
Total ...................................................................................

Average
burden
hours per
response

Estimated
total annual
burden hours

76,911
45,316

0.33
0.33

0.08
0.08

2,051
1,208

4,117
5,500
3,578
954
912
893
954
500
500
364
* 79,229

1.33
1
0.33
7
2
4
2
0.33
0.33
0.33
............................

1.15
0.08
0.08
0.62
0.38
0.81
0.72
0.05
0.05
1.00
............................

6,285
458
95
4,134
684
2,887
1,370
8
8
121
19,209

rwilkins on PROD1PC63 with NOTICES

* Total number of respondents is less than the sum of the column since the mothers will be identified in the household enumeration and
screening.

The estimated annualized cost to
respondents is $234,488 based on the
differential hourly rate estimates in the
above table. There are no Capital Costs
to report. There are no Operating or
Maintenance Costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who

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20:17 Nov 16, 2007

Jkt 214001

are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
FOR FURTHER INFORMATION CONTACT:

request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Kenneth C.
Schoendorf, MD, MPH, National
Institute of Child Health and Human
Development, Building 6100, 5C01,
6100 Executive Blvd, Bethesda,
Maryland, 20892, or call non-toll free
number (301) 594–9147, or e-mail your
request, including your address to
[email protected].
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 60-days of the date of
this publication.

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Dated: November 6, 2007.
Paul Johnson,
NICHD Project Clearance Liaison, National
Institutes of Health.
[FR Doc. E7–22597 Filed 11–16–07; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Notice of Establishment
Pursuant to the Federal Advisory
Committee Act, as amended (5 U.S.C.
Appendix 2), the Director, National
Institutes of Health (NIH), announces
the establishment of the Emerging
Neuroscience and Training Integrated
Review Group.
The Emerging Neuroscience and
Training Integrated Review Group shall

E:\FR\FM\19NON1.SGM

19NON1

Appendix C.5
Outside Groups Consulted

Appendix C

C.5.1–1
Federal Advisory Committee
11/19/2007

National Children’s Study 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.
Charter

Roster of Members
Alan R. Fleischman, MD (Chair)
Senior Vice President and Medical Director
March of Dimes
Kate (Costella) Winseck, MSW (Executive Secretary)
Outreach and Communications Coordinator, National Children's Study
Jessica N. Sapienza, MHS (Committee Liason Officer)
Adjunct Studies Program Analyst, National Children’s Study
John L. Butenhoff, PhD, CIH, DABT
Medical Department
3M Company
Robert E. Chapin, PhD
Investigative Developmental Toxicology Lab
Pfizer Global Manufacturing Plant
Frank A. Chervenak, MD
Department of Obstetrics and Gynecology
Weill Medical College of Cornell University and NewYork-Presbyterian Hospital
Janet Currie, PhD
Department of Economics
Columbia University

Appendix C

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
Antoinette P. Eaton, MD
Faculty Emeritus, Department of Pediatrics
Ohio State University
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
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
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
Barbara Anne Nabrit-Stephens, MD, MBA, FAAP
Care Management
Blue Cross Blue Shield of Florida

C.5.1–2

Appendix C

Gary Q. Peck, MD, FAAP
General Pediatric/Adolescent Medicine Physician
Robert C. Pianta, PhD
Center for Advanced Study in Teaching and Learning
University of Virginia
Amelie G. Ramirez, DrPH
Department of Epidemiology and Biostatistics
University of Texas Health Science Center at San Antonio
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)
Alan M. Zaslavsky, PhD
Department of Health Care Policy
Harvard University Medical School
Duane F. Alexander, MD (ex officio member)
Director
National Institute of Child Health and Human Development
National Institutes of Health, DHHS
Allen Dearry, PhD (ex officio member)
Associate Director, Research Coordination, Planning, and Translation
National Institute of Environmental Health Sciences
National Institutes of Health, DHHS
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, DHHS
Page updated - 11/19/07

C.5.1–3

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 (DHHS) and the U.S. Environmental Protection Agency
(EPA). Within DHHS, 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 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
Office of Children’s Health Protection, EPA
Amy Branum, MSPH
National Center for Health Statistics, CDC, DHHS
Adolfo Correa, MD, PhD
National Center on Birth Defects and Developmental Disabilities, CDC, DHHS
Sally Perreault Darney, PhD
National Health and Environmental Effects Laboratory, EPA
Nigel A. Fields, MSPH
National Center for Environmental Research, EPA
Ron Iannotti, PhD
NICHD, NIH, DHHS
Sarah Keim, MA, MS
NICHD, NIH, DHHS
Sheila A. Newton, MS, PhD
NIEHS, NIH, DHHS
James J. Quackenboss, MS
National Exposure Research Laboratory, EPA
Peter C. Scheidt, MD, MPH
NICHD, NIH, DHHS

Appendix C
Kenneth Schoendorf, MD, MPH
National Center for Health Statistics, CDC, DHHS
Marshalyn Yeargin-Allsopp, MD
National Center on Birth Defects and Developmental Disabilities, CDC, DHHS
Page updated–09/11/07

C.5.2–2

Appendix C

C.5.3–1
Steering Committee

Steering Committee
The National Children’s Study Steering Committee consists of one voting member from each of
the Vanguard Centers; the National Children’s Study Director, who is also the Chair of the
Steering Committee; the two Co-Project Officers of the Coordinating Center and Vanguard/Study
Centers; and two voting members from the Interagency Coordinating Committee.
Steering Committee Members
Ruth Brenner, MD, MPH
National Children’s Study Program Office, NICHD, NIH, DHHS
Edward B. Clark, MD
Department of Pediatrics, University of Utah
Christine Cronk, ScD
Department of Pediatrics, Medical College of Wisconsin
Jennifer Culhane, PhD, MPH
Department of Obstetrics and Gynecology, Drexel University College of Medicine
Maureen Durkin, PhD, DrPH
Department of Population Health Sciences, University of Wisconsin
Jonas Ellenberg, PhD
Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine
Barbara Entwisle, PhD
Carolina Population Center, University of North Carolina, Chapel Hill
Alexa Fraser, PhD
Westat
Matthew Gillman, MD, SM
Department of Ambulatory Care and Prevention, Harvard Medical School
Sarah Knox, PhD
National Children’s Study Program Office, NICHD, NIH, DHHS
Philip Landrigan, MD
Department of Community and Preventive Medicine, Mount Sinai School of Medicine
Bruce Lanphear, MD, MPH
Children’s Environmental Health Center, Cincinnati Children’s Hospital Medical Center
Carla Maffeo, PhD
Westat
James J. Quackenboss, MS
National Exposure Research Laboratory, EPA

Appendix C

C.5.3–2

David Savitz, Ph.D.
Center of Excellence in Epidemiology, Biostatistics, and Disease Prevention, Mount Sinai School of
Medicine
Peter Scheidt, MD, MPH
National Children’s Study Program Office, NICHD, NIH, DHHS
Kenneth Schoendorf, MD, MPH
National Center for Health Statistics, CDC, DHHS
Donald Schwarz, MD, MPH
Department of Pediatrics, Children’s Hospital of Philadelphia
Stacy Scott
In Black Print, Inc.
Bonny Specker, PhD
Ethel Austin Martin Program in Human Nutrition, South Dakota State University
James Swanson, PhD
Child Development Center, University of California, Irvine
Ruth Thomson, MPH
Westat
Updated - 01/17/08

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

Appendix C
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
Page updated - 04/06/07

C.5.4 –2

This page is intentionally blank.

Appendix C.6
Incentive Plan

NCS
Proposal for Incentives (not including expense reimbursements)

In-person interview,
Environmental,
Biospecimens, and/or
Physical measures, and/or
Leave-behinds

P1
Home
Visit
$100 total,
$80 after interview
and technical
collection
$20 at receipt of
self collection (1)
by cash or check (2)

P1 mo.
High
Phone

P4 mo.
High
Phone

P-Moderate

P-Low

T1 First / Prior
Home Visit

T1 Ultrasound (U/S)
(if needed)

T 16-17
wk.
Phone

T2 U/S

Non-cash
incentive for
mother mailed
after call

None

T3 Clinic Visit

T3 U/S
(if separate visit
required)

T36
wk.
Phone

$100 total,
$80 at end of clinic visit,
$20 at receipt of self
collection

$100 total mother,
$100 total father,
$80 after interview
and technical
collection
$20 after receipt of
self collection
None

Telephone interview only

P2 mo.
High
Phone

None

Mailed request for SAQ or
other (no in-person contact)
None

Ultrasound only

In-person interview,
Environmental,
Biospecimens, and/or
Physical measures, and/or
Leave-behinds

B1 Plus B2
Mother/Child
(Hospital)

1 mo. (only if no
B1 Plus B2)
Home
Visit

mother - cash
incentive at receipt
of self collection (3)
-------------------child - non-cash
baby item given at
discharge (3)

See B1 Plus B2
for mother/child

Telephone interview only

Mailed request for SAQ or
other (no in-person contact)

(1)
(2)
(3)

3 mos.
Phone

6 mos.
Home
Visit

9 mos.
Mom
Phone

9 mos.
Dad
Phone

18 mos.
Mom
Phone

18 mos.
Dad
Self
Collection

24 mos.
Phone

None

$40 mailed at
receipt of self
collection

None

$100 total mother,
$100 total father,
------------------mother/father $80 after interview
and technical
collection
$20 at receipt of
self collection,
-----------------child - non-cash
baby item at the
end of visit

$100 total mother,
$20 total father,
-----------------mother-$80 after
interview and
technical collection
$20 at receipt of
self collection,
------------------father-$20 at receipt
of self collection,
-------------------child-non-cash baby
item after
measurements
taken

None

12 mos.
Home
Visit

None

Defined as receipt of SAQs/self collected samples
VCs can choose to distribute each cash incentive as cash or by check
Cash and non-cash incentive combined will total $50.00

Appendix C

C.6-1

This page is intentionally blank.

Appendix C.7
Certificate of Confidentiality

Appendix C

C.7–1
Certificate of Confidentiality

(To come)

This page is intentionally blank.

Appendix C.8
Sampling and Recruitment Plan

Appendix C

C.8–1
SAMPLING AND RECRUITING PLAN

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).

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

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. These segments are homogenous with respect to the stratification
variables but may not be geographically contiguous, thus increasing data collection costs. 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 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. 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.

Appendix C
1.4

C.8–4
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
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. 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 at least once a year. This contact will be used to
update the status of enrolled women’s likelihood of pregnancy and thus her schedule for follow-up visits.
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 mid-2008, data collection in the first wave of
additional PSUs is planned to begin in mid-2009 with the second wave 2 years later and the final wave 2
years after that.
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

Appendix C

C.8–5

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
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.
For the initial year of data collection in the Vanguard sites, we also have developed plans to
subsample women who are identified as having the greatest chance for becoming pregnant. The general
plan is that all women in this category will be scheduled for the initial in-person visit to collect prenatal
data. Since there are several factors that may cause the number of women in this group to vary and these
factors can only be modeled at this time, a subsampling scheme will be implemented in a PSU if the
number of women identified for the visit is larger than the data collection capacity. The subsampling may
differ by the characteristics the women report in the pregnancy screening interview. No subsampling for
the prenatal visits will be done in any site unless the expected number of women sampled for the visits
becomes too large.
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, all households will be enumerated to identify women of childbearing 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 age-eligible women (18–44) are targeted for enrollment: women who are in
their first trimester or pregnancy and women who are at some probability of becoming pregnant during

Appendix C

C.8–6

the 4-year enrollment period. After the age-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
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 periodic
rescreening will take place only for those households where no eligible women are identified (estimated
to be approximately 70 percent of all households). For those households with women being followed as
part of the Study, scheduled contacts will be used to update information about household membership.
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

Appendix C

C.8–7

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
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

Appendix C

C.8–8

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.

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?

RFP. National Children’s Study. NIH, NICHD. 2004. Available at:
http://www.nationalchildrensstudy.gov/research/study_plan/index.cfm Accessed December 6, 2006

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

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.

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. 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” questionnaire 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 feedback at

Appendix C

C.9.1–4

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.

Appendix C

C.9.1–5

QUESTIONNIARE ADDRESSING:
EVALUATION OF COMMUNITY ENGAGEMENT
ACTIVITIES

Appendix C

C.9.1–6

VC puts label here that identifies NCS
event and numbers the questionnaire

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

_____

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.

Appendix C

C.9.1–8

QUESTIONNIARE ADDRESSING:
AWARENESS OF NCS
(FOLLOWING THE PREGNANCY SCREENER)

Appendix C

C.9.1–9

(Questions at the close of the pregnancy screener)
1. Before today, had you heard about the National Children’s Study?

□
□

Yes
No Æ skip to the close of the pregnancy screener

2. How did you hear about the National Children’s Study? (check all that apply)

□
□
□
□
□
□
□
□
□
□

Friends or acquaintances
Family members
Church, synagogue or other religious affiliation
A community leader
Someone else in the community (other than the NCS researchers)
Doctor or health care provider
Newspaper, T.V. or radio
Billboard
A letter in the mail
Other Æ specify: _______________________________________________________

3. Have you taken part in any local or community activities sponsored by the National
Children Study, such as town meetings, community forums, community advisory
boards, health fairs, or other activities?

□
□

Yes
No Æ Continue to audio-casi.

4. Would you describe the event as something like a health fair, a meeting with at least
one speaker who presents information to an audience, a discussion group with a
limited number of people participating, or something else?

□
□
□
□

A health fair (READ IF NECESSARY: for example, an event with informational booths or
other health monitoring booths available for people to stop at as they choose),
A meeting with at least one speaker who presents information to an audience,
A discussion group with a limited number of people,
Or something else Æ Please describe:
______________________________________________________________________
______________________________________________________________________
-- CAPI continues with close of pregnancy screener module --

Appendix C

C.9.1–10

QUESTIONNIARE ADDRESSING:
PARTICIPANT EVALUATION OF DATA COLLECTION
ACTIVITIES

Appendix C

C.9.1–11

NATIONAL CHILDREN’S STUDY
Participant Evaluation Questionnaire
Thank you for participating in the National Children’s Study (NCS). We would appreciate you
taking a few minutes to answer some questions about your experience in the study so far.
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. Additionally, your feedback can help us
improve this phase of the study for other women who haven’t yet participated. 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 participation in the National Children’s Study (NCS) will not be affected. As
with all other NCS activities, the information you provide will be kept confidential and used only
for purposes of the study.
1. Did a study representative conduct an interview with you?

□
□

Yes
No

(GO TO 2)

1a. How much time did you spend on the interview?

□
□
□

Far too much time
A little too much time
An acceptable amount of time

1b. How uncomfortable or comfortable did you feel completing an interview with
the study representative?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Comfortable

1c. How clearly did a study representative explain the interview process to you?

□
□
□
□

Did not explain clearly at all
Explained somewhat clearly
Explain pretty clearly
Explained very clearly

Appendix C

C.9.1–12

2. Did a study representative collect environmental samples from your home, such as
water, air, dust, or soil?

□
□

Yes
No

(GO TO 3)

2a. How much time did a study representative spend collecting environmental
samples from your home?

□
□
□

Far too much time
A little too much time
An acceptable amount of time

2b. How uncomfortable or comfortable did you feel with the study representative
collecting environmental samples from your home?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Comfortable

2c. How clearly did a study representative explain the process of collecting
environmental samples to you?

□
□
□
□

Did not explain clearly at all
Explained somewhat clearly
Explain pretty clearly
Explained very clearly

3. Did you collect any environmental samples for the study, such as water, air, dust, or
soil samples?

□
□

Yes
No

(GO TO 4)

3a. How much time did you spend collecting your own environmental samples for
the study?

□
□
□

Far too much time
A little too much time
An acceptable amount of time

Appendix C

C.9.1–13

3b. How uncomfortable or comfortable did you feel collecting your own
environmental samples?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Comfortable

3c. How clearly did a study representative explain the process of collecting your
own environmental samples?

□
□
□
□

Did not explain clearly at all
Explained somewhat clearly
Explain pretty clearly
Explained very clearly

4. Did a study representative collect any biospecimens from you, such as blood, saliva,
hair, or nail clippings?

□
□

Yes
No

(GO TO 5)

4a. How much time did a study representative spend collecting biospecimens?

□
□
□

Far too much time
A little too much time
An acceptable amount of time

4b. How uncomfortable or comfortable did you feel allowing a study representative
collect biospecimens?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Comfortable

4c. How clearly did a study representative explain the process of collecting
biospecimens to you?

□
□
□
□

Did not explain clearly at all
Explained somewhat clearly
Explain pretty clearly
Explained very clearly

Appendix C

C.9.1–14

5. Did you collect any of your own biospecimens for the study such as vaginal swabs or
urine?

□
□

Yes
No

(GO TO 4)

5a. How much time did you spend collecting your own biospecimens for the study?

□
□
□

Far too much time
A little too much time
An acceptable amount of time

5b. How uncomfortable or comfortable did you feel collecting your own
biospecimens for the study?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Comfortable

5c. How clearly did a study representative explain the process of collecting your
own biospecimens to you?

□
□
□
□

Did not explain clearly at all
Explained somewhat clearly
Explain pretty clearly
Explained very clearly

6. Did a study representative collect any physical measures from you, such as blood
pressure, weight, or height?

□
□

Yes
No

(GO TO 7)

6a. How much time did a study representative spend collecting physical measures
from you?

□
□
□

Far too much time
A little too much time
An acceptable amount of time

Appendix C

C.9.1–15

6b. How uncomfortable or comfortable did you feel having a study representative
collect physical measures?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Comfortable

6c. How clearly did a study representative explain the process of collecting
physical measures to you?

□
□
□
□

Did not explain clearly at all
Explained somewhat clearly
Explain pretty clearly
Explained very clearly

7. Did you complete any paper questionnaires given to you by a study representative?

□
□

Yes
No

(GO TO 8)

7a. How much time did you spend on the paper questionnaires?

□
□
□

Far too much time
A little too much time
An acceptable amount of time

7b. How uncomfortable or comfortable did you feel completing the paper
questionnaires?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Comfortable

7c. How clearly did a study representative explain the paper questionnaires to you?

□
□
□
□

Did not explain clearly at all
Explained somewhat clearly
Explain pretty clearly
Explained very clearly

Appendix C

C.9.1–16

T3X. (T3 VERSION ONLY) At a previous visit, the study representative may have left a
diary with you to help keep track of things between visits such as any illnesses
you experienced, injuries, or medicines that you may have used.
If you received a diary, how difficult or easy was it to use the diary?

□
□
□
□
□

Very difficult
Somewhat difficult
Somewhat easy
Very easy
I did not receive a diary

Appendix C

C.9.1–17

8. How important were each of the following in your decision to participate in this phase
of the National Children’s Study?
Not At All
Important

Not Too
Important

Somewhat
Important

Very
Important

a. Receiving payments or gifts for your
participation?

_____

b. Learning more about your health or the health
of your child?

_____

c. Helping your child as he/she develops?

_____

d. Getting medical information about myself or my
child that I wouldn’t otherwise receive, including
referrals to other doctors or specialists?

_____

e. Feeling as if you can help children now and in
the future?

_____

f. Contributing to science?

_____

g. To help the environment?

_____

h. Feeling part of my community?

_____

i. Knowing other people in the study?

_____

j. Having family members or friends support your
decision to participate in the study?

_____

k. Having your doctor support your decision to
participate?

_____

l. Having a good relationship with the NCS
researchers?

_____

Appendix C

C.9.1–18

9. How much do each of the following people discourage or encourage your
participation in the National Children’s Study?

Very
Discouraging

Somewhat
Discouraging

Neither
Encouraging
or
Discouraging

a. Family members

_____

b. Friends

_____

c. Your doctor or
health care provider

_____

Somewhat
Encouraging

Very
Encouraging

T3Y. (T3 VERSION ONLY) How difficult or easy is it to schedule appointments for home
or clinic visits?

□
□
□
□

Very difficult
Somewhat difficult
Somewhat easy
Very easy

T3Z. (T3 VERSION ONLY) How uncomfortable or comfortable are you at the NCS study
center?

□
□
□
□

Very uncomfortable
Somewhat uncomfortable
Somewhat comfortable
Very comfortable

10. In general, how would you describe your experiences as a participant in the National
Children’s study?

□
□
□
□
□

Very negative
Somewhat negative
Neither negative or positive
Somewhat positive
Very positive

Appendix C

C.9.1–19

11. Of all the study activities you participated in so far, which one did you like the most?
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________

12. Is there anything we can do to make your participation in NCS more enjoyable?
_________________________________________________________________________
_________________________________________________________________________
_________________________________________________________________________

13. 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

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 before he or she leaves today. If the study
representative leaves before you finish, or if you prefer, you also can return your completed
questionnaire by mail using the postage-paid envelope.

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
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.

Appendix C

C.9.4–1

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.

This page is intentionally blank.

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).

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.

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

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.

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.

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.

Appendix C

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.

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.

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

Nitrate - non-community water source only
Soil

Water

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
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.

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
8

1
2
3
4
5
6
77
88

Source: Child Care Choices Study, Australia (A2, A3, A7), Early Head Start National Evaluation, 14 month Father
Interview (A4-A6)

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 .........................................................................................

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 __________________________________________
__________________________________________________) ......

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 ........................................................................................

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

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.
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.

Appendix C

C.10.5–3

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.
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.

Appendix C

C.10.5–4

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.
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.

Appendix C

C.10.5–5

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 (NCS)

APPENDIX X: REPORT OF FINDINGS AND REFERRALS

Overview
Participants in the National Children’s Study (NCS) will receive notification of the

results of some of the exams and tests that they participate in as part of the Study. The method
and time frame for communicating the results to participants will depend on the medical findings
and the time required for processing the results.

In instances where the exam results are

immediately available (e.g., blood pressure), the participant will receive the results at the end of
their exam, in a Preliminary Report of Findings printed on a hard copy form. Some reportable
results will not be processed immediately but will be sent to participants 8–12 weeks following the
exam in a Final Report of Findings.
In instances where exam results indicate further medical attention, participants also
will receive a referral letter with information about the results and a recommendation regarding
the time frame when they should contact their health care provider about these results. Referrals
will be distributed during home or clinic visits for immediately available test results or via the mail
and/or the Internet for biospecimen results.

Preliminary Report of Findings
Participants will receive a Preliminary Report of Findings after completing a physical

exam, either at home or at a clinic. The findings for those exam results that are immediately
available (e.g., blood pressure) will be written on a hard copy form. In addition to exam results,
the Preliminary Report of Findings also will include an interpretation of the results based on
predetermined criteria. The interpretation will, in most cases, be different for adults and children.
The Visit Coordinator will be responsible both for giving the participant the
Preliminary Report of Findings and verbally reviewing the results with the participant. The form
will list an 800 number for the participant to call should they have follow-up questions about the
tests or results.

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Appendix C

C.11–2

National Children’s Study: Report of Findings and Referrals
The tests and measures that will be reported in the Preliminary Report of Findings
include blood pressure, heart rate, weight, height, and body mass index. A brief description of
the criteria and statements for these reported measures is outlined below.
Blood Pressure (adults): Systolic and diastolic blood pressure are categorized into
specific ranges and assigned a statement indicating whether the results are within the normal
range or in one of several ranges above the normal range. See Table 1 for Report of Findings
statements for adults 18 years and above. The cells specify the blood pressure category (1–5)
for the systolic and diastolic blood pressure combination. The category number defines the
statement used for the report of findings.

If the results are above the normal range, the

participant will also receive a referral letter to give to their physician (See Section 4 for referral
procedures).
Table 1.
Category

Statement by result category for blood pressure report of findings (adults 18+) 1
Systolic

Diastolic

Report of Findings Statement:
“Your blood pressure today is…”

<120

<80

…within the normal range. 11

120-139

80-89

…above normal and is in the pre-hypertensive range. 1

140-159

90-99

…high. 1

160-209

100-119

…very high. 1

>209

>119

…severely high.

Blood Pressure (children): 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. 2 The tables provide matrices of combinations of systolic and diastolic blood
pressure results by percentile of height for males and females ages 6 through 17 years. The
matrix cells specify the blood pressure category (1–4) for the systolic and diastolic blood pressure
combination. The category number defines the statement used for the report of findings. See
Table 2. If the results are above the normal range, the participant will also receive a referral letter
to give to their physician (See Section 4 for referral procedures).
1

Seventh Report of the Joint National Committee on the Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.
NIH Publication, 2003

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.

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Appendix C

C.11–3

National Children’s Study: Report of Findings and Referrals

Table 2.

Statements by result category for blood pressure report of findings (children)2

Category
1
2
3
4

Report of findings statement
“You child’s blood pressure today …”
…is within the normal range.*
…is normal but at the high end of normal range.*
…high.*
… very high.*

Weight, height and body mass index: Children less than 3 years of age will be
given results for weight and recumbent length. Body mass index will not be calculated for this age
group. Although measurements are recorded in metric units for data collection purposes, the
results for the Report of Findings will be converted to English units.
Weight and height measurements along with the calculated body mass index (BMI)
from each visit will be given to participants ages 20 years and above at the end of the visit.
These measurements along with a brief statement about the significance of the results will be
printed on the hard copy report. The technician will check the appropriate statement based on
the body mass index percentile. The statements for this age group associated with each body
mass index category are displayed in Table 3.
Table 3.

Statements by BMI categories for report of findings (>20 years).
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

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Obese

Appendix C

C.11–4

National Children’s Study: Report of Findings and Referrals
Exhibit 1. Sample Preliminary Report of Findings hard copy form (<20 years)

{NCS Letterhead}
National Children’s Study
PRELIMINARY REPORT OF FINDINGS†
Date of Examination:

__ __ /__ __ /20 __ __

Participant Name:

_____________________

BODY MEASUREMENTS
Height:

__ feet __ __ inches

Weight:

__ __ __ pounds

Body Mass Index (BMI):

__ __ .__

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 based on your body mass index can
be determined from the table below:
Body Mass Index

Weight Status

Below 18.5

Underweight

18.5–24.9

Normal

25.0–29.9

Overweight

30 & above

Obese

BLOOD PRESSURE AND HEART RATE
Systolic Blood Pressure:

__ __ __ mmHg

Diastolic Blood Pressure:

__ __ __ mmHg

Resting Heart Rate:

__ __ __ beats per minute

Your blood pressure today is*

___ within the normal range
___ above normal and is in the pre-hypertensive range
___ high
___ very high
___ severely high

*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 examinations 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.

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Appendix C

C.11–5

National Children’s Study: Report of Findings and Referrals
Ultrasound image:

Participants will be given an image from each of the

ultrasounds performed as part of the study.
A sample Preliminary Report of Findings for participants 20 years and above is
displayed in Exhibit 1.

Final Report of Findings
The Final Report of Findings will be generated electronically and will include all

reportable exam results, regardless of referral level or the time it takes to process the results. The
information provided in the Preliminary Report of Findings at the end of the exam visit will be
repeated in the Final Report for the convenience of the participant. This includes blood pressure,
heart rate, weight, height, body mass index and water-nitrates. Hemoglobin, hematocrit and
water VOC will be included in the final report. An interpretation of the results will be included
based on predetermined criteria.
The Visit Coordinator is responsible for ensuring that the Final Report of Findings is
mailed to the respondent within 8–12 weeks of the examinations. The report will include an 800
number that the participant can call if there are any follow-up questions. An example of a Final
Report of Findings is located in Exhibit 2a and 2b. The information that was provided in the
Preliminary Report of Findings at the end of the exam visit will be repeated in the Final Report for
the convenience of the participant.

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Appendix C

C.11–6

National Children’s Study: Report of Findings and Referrals

Exhibit 2a. Sample Final Report of Findings (electronic)

{NCS Letterhead}
National Children’s Study
FINAL REPORT OF FINDINGS†
Date of Examination:

Participant Name:

(A copy of your blood pressure, heart rate, weight, and height results was given to you at the end
of your visit. For your convenience, those results are listed again on this report.)
Laboratory
Measured Hemoglobin:
Measured Hematocrit

Normal Values for Hemoglobin:
Adult Males:

13.0–17.0 g/dL

Adult Females:

12.0–15.0 g/dL

Infants, after neonatal period:

11.0–14.0 g/dL

Children, 2 years to teenage:

Gradual increase to adult normals

Anthropometry
Height:

Weight:

Body Mass Index (BMI)
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:

9-15-07

Body Mass Index

Weight Status

Below 18.5

Underweight

18.5–24.9

Normal

25.0–29.9

Overweight

30 & above

Obese

Appendix C

C.11–7

National Children’s Study: Report of Findings and Referrals
Exhibit 2b. Sample Final Report of Findings (page 2)
National Children’s Study Final Report of Findings†
Page 2
Blood Pressure and Heart Rate
Your Measurements
Systolic Blood Pressure:

Diastolic Blood Pressure:

Resting Pulse Rate:

Your blood pressure result is*

___ within the normal range
___ above normal and is in the pre-hypertensive range
___ high
___ very high
___ severely high

Your blood pressure today is 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 examinations 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.

Environmental Samples
Water VOCs

{insert statement to explain the significance of the results}

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Appendix C

C.11–8

National Children’s Study: Report of Findings and Referrals

Referrals
Although the purpose of the NCS examinations is data collection, not diagnosis or

treatment, physical exams and analysis of biospecimens and environmental samples may yield
clinically significant findings that warrant further medical attention.

In these situations,

participants will receive same-visit notification of major medical findings for those exam results
that are immediately available (e.g., blood pressure) and a referral letter will be issued to
participants to give to their health care provider.
Exam results are classified into three referral levels. Referral letters will be given for
results that fall in Level 1 and 2 categories.
Level 1: Major medical findings that warrant immediate attention by a health care provider.
Level 2: Major medical findings that require attention by a health care provider within the
next two weeks because they are expected to cause adverse 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.

Immediate referrals (at the end of the exam): The only exam result available at
the end of the exam to establish the need for a referral is blood pressure. 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 (for adults) and Exhibit 5 (for children). The Visit Coordinator will provide
verbal instructions to see their health care provider immediately. If the examiner believes the
participant is in imminent danger, he or she will also call 911 for medical assistance. In the case
of Level 2 findings, the Visit Coordinator will be responsible for providing the respondent with a
referral letter and specific form and instructions to see their 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.

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Appendix C

C.11–9

National Children’s Study: Report of Findings and Referrals
Later referrals (when tests are processed): Referrals also will be issued for
laboratory results that are processed after the exam (i.e., hemoglobin) indicating Level 1 or Level
2 findings. The Visit Coordinator will be responsible for calling participants and notifying them of
Level 1 findings within two days of the test results being finalized. The Visit Coordinator will also
be responsible for mailing and/or emailing a standard referral letter (Exhibit 3) and a specific
referral form for Level 1 and Level 2 findings (Exhibit 6) within 2 days of the test results being
finalized. This will inform the participant of the need to see a physician about the results and
include an 800 number that they may call to contact the Visit Coordinator with further questions.
Where the results pertain to environmental samples, the participant also will receive a pamphlet
on the potential risks of the environmental exposure in addition to a referral letter (Exhibit 6). The
Referral Form will list an 800 number where the doctor can reach the Visit Coordinator should
they have any questions about the study. A Referral Information Form also will be included with
each Referral.

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Appendix C

C.11–10

National Children’s Study: Report of Findings and Referrals

Exhibit 3. Sample Standard Referral Letter for Physical Measures and Laboratory

{NSC Letterhead}
National Children’s Study
Referral Letter
Participant’s Name:

___________________________________

Physician’s Name:

___________________________________

Address:

___________________________________
___________________________________
___________________________________

Date:

__ __ /___ ___/ 20 ___ ___

Dear Doctor:
has voluntarily participated in the National Children’s Study conducted by
and the National Institute of Child Health and Development. The objectives
of the National Children’s Study are to obtain information on the health and development of U.S.
children, including the health of their parents. As a result of the testing that was done, it was
noted that on , a finding was revealed that was outside the survey’s medically
acceptable range. This finding is described on the attached Referral Information Form page.
This examination is intended to collect health measures for research.
physical exam.
participants.

It is not a complete

No attempt has been made to diagnose or treat medical conditions of the

The findings disclosed to you are done so with the participant’s. The findings

disclosed to you are done so with the participant’s permission.
Should you have any questions, you may contact me at . The phone
number is .
Cordially,

Study Center Coordinator

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Appendix C

C.11–11

National Children’s Study: Report of Findings and Referrals

Exhibit 4.

Referral Information Form for Blood Pressure (Adults 18+)

{NCS LETTERHEAD}
National Children’s Study
Referral Information Page for Blood Pressure (18 years and above)
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 pressure was calculated from the remaining readings. The results are recorded
below.
Systolic Blood Pressure:

_________mm Hg

Diastolic Blood Pressure:

_________mm Hg

Heart Rate:

_________beats per minute

The participant’s blood pressure is:

__ within the normal range*
__ above normal and in the prehypertensive range*
__ high*
__ very high*

It is highly recommended that your child see their physician:
___ immediately
___ within 2 weeks

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Appendix C

C.11–12

National Children’s Study: Report of Findings and Referrals

Exhibit 5.

Referral Information Form for Blood Pressure (Child 6–17)

{NCS LETTERHEAD}
National Children’s Study
Referral Information Form for Blood Pressure (Child 6–17)
Blood pressure was measured in a seated/supine position after resting quietly for several
minutes. Three measurements were taken, the first measure was discarded and an average
systolic and diastolic blood pressure was calculated from the remaining readings. The results are
recorded below:
Systolic Blood Pressure;

_________mm Hg

Diastolic Blood Pressure:

_________mm Hg

Heart Rate:

_________beats per minute

The participant’s blood pressure is:

__ within the normal range*
__ normal but in the high end of normal*
__ high*
__ very high*

It is highly recommended that your child see their physician:
___ immediately
___ within 2 weeks

Additional comments:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
* Categories are based on the 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

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Appendix C

C.11–13

National Children’s Study: Report of Findings and Referrals
Exhibit 6.

Referral Information Form for Laboratory Results

{NCS LETTERHEAD}
National Children’s Study
Referral Information Form for Laboratory Results

Measured Hemoglobin:
Calculated Hematocrit
Normal Values for Hemoglobin:
Adult Males:

13.0–17.0 g/dL

Adult Females:

12.0–15.0 g/dL

Infants, after neonatal period:

11.0 –14.0 g/dL

Children, 2 years to teenage:

Gradual increase to adult normals

Action Limits for Hemoglobin*:

Low

High

Male & female (<6years)

<6.5 g/dl

>14.5 g/dL

Female (>6years)

<6.5 g/dL

>16.0 g/dL

Male (>6.5 g/dL)

<6.5 g/dL

>18.0 g/dl

It is recommended that see their physician within 2 weeks.

Additional comments:
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
_______________________________________________________________________
* Categories are based on data from the National Health and Nutrition Examination Survey (NHANES),

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Appendix C.12
IRB Certifications

Appendix C

C.12–1
IRB Certifications

(To come)

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File Type	application/pdf
File Title	Appendix A
Author	Duane Walker
File Modified	2008-01-25
File Created	2008-01-25