Attach. 5 Instruments by Data Collection Activity

Attachment 5: NCS Vanguard Study Instruments by Data Collection Activity,

Study Visits through 60 Months

(As of May 15, 2014)

Note: New instruments and/or collections are bolded and instruments not yet reviewed by OMB are in italics; instruments may be both bolded and italicized.
Data Collection Activity	Type of Respondent	Instruments
Pregnancy Screening Activities
Pregnancy Screener Sibling Birth Cohort SAQ (9M to 60M)	Biological Mother	Pregnancy Screener Sibling Birth Cohort SAQ
Retrospective Pregnancy Interview (Birth, 3M, 6M)	Biological Mother	Retrospective Pregnancy Birth Cohort Questionnaire Adult Retrospective Pregnancy Birth Cohort Quex Household Retrospective Pregnancy Birth Cohort SAQ
Continuous Activities
Participant Verification & Tracing (PVT) Interview (PV1 to 60M)	Pregnant Woman, Father/Father Figure, Biological Mother, Primary Caregiver, Secondary Residence Caregiver	Participant Verification & Tracing Questionnaire PVT Contact Verification Form PVT Key Data Verification Form
Validation Interview (Pre-Pregnancy to 60M)	Pregnant Woman, Father/Father Figure, Biological Mother, Primary Caregiver, Secondary Residence Caregiver	Validation Questionnaire
Participant Information Update - Incentive Substudy (24M to 60M)	Primary Caregiver	Participant Information Update Monetary Incentive Now SAQ Participant Information Update Monetary Incentive Later SAQ Participant Information Update Gift Incentive Now SAQ Participant Information Update Gift Incentive Later SAQ
Interviewer Observation Interview (Pre-Preg to 60M)	Data Collector*	Interviewer Observation Instrument Child Interviewer Observation Instrument Adult Interviewer Observation Instrument Household
Event Driven Activities
Pregnancy Loss, Stillbirth, & Neonatal Death Interview (PV1, PV2, Birth)	Pregnant Woman, Biological Mother	Pregnancy Loss, Stillbirth, & Neonatal Death Questionnaire PLSND SAQ & Release Form Letter PLSND Phone Medical Records & Death Certificate Release Form Letter PLSND Phone Medical Records Release Form Letter PLSND Mail & Phone Reminder Call Script*
Parent-Caregiver Death Interview (3M to 60M)	Proxy	Parent-Caregiver Death Questionnaire
Child Death Interview (3M to 60M)	Primary Caregiver	Child Death Questionnaire
Non-Interview Respondent Interview (Pre-Pregnancy to 60M)	Pre-Pregnant Woman, Pregnant Woman, Father/Father Figure, Biological Mother, Primary Caregiver	Non-Interview Respondent SAQ
Secondary Residence Interview (3M to 60M)	Secondary Residence Caregiver	Secondary Residence Questionnaire
Preconception Activities
Pre-Pregnancy Interview	Pre-Pregnant Woman	Pre-Pregnancy Questionnaire Adult Pre-Pregnancy Questionnaire Household Pre-Pregnancy SAQ
Adult-Focused Biospecimen Collection - Blood & Urine	Pre-Pregnant Woman	Adult Blood Instrument Adult Blood Prescreening Questionnaire Adult Urine Instrument & Instructions
Pregnancy Probability Group Follow-up	Pre-Pregnant Woman	Pregnancy Probability Group Follow-up Questionnaire
Pre-Natal Activities
Pregnancy Visit 1 Interview	Pregnant Woman	Pregnancy Visit 1 Questionnaire Adult Pregnancy Visit 1 Questionnaire Household Pregnancy Visit 1 SAQ NIH Toolbox Emotion Battery
Pregnancy Visit 2 Interview	Pregnant Woman	Pregnancy Visit 2 Questionnaire Adult Pregnancy Visit 2 Questionnaire Household Pregnancy Visit 2 SAQ
Adult-Focused Biospecimen Collection - Blood & Urine (PV1, PV2)	Pregnant Woman	Adult Blood Instrument Adult Blood Prescreening Questionnaire Adult Urine Instrument & Instructions
Environmental Sample Collection - Vacuum Bag Dust (PV1)	Primary Caregiver	Vacuum Bag Dust Instrument
Father Pre-Natal Interview (PV1 or PV2)	Father/Father Figure	Father Pre-Natal Questionnaire Adult Father Pre-Natal Questionnaire Household
Pregnancy Health Care Log (PV1 or PV2)	Biological Mother	Pregnancy Health Care Log
Birth Activities
Birth Interview	Biological Mother	Birth Questionnaire Child Birth Questionnaire Adult Birth Questionnaire Household
Adult-Focused Biospecimen Collection - Blood, Urine, Cord Blood, Breast Milk, Placenta, & Microbiome Swab	Biological Mother	Adult Blood Instrument Adult Blood Prescreening Questionnaire Adult Urine Instrument & Instructions Cord Blood Instrument* Breast Milk SAQ, Instructions, & Letter Breast Milk Kit Distribution & Pick Up Instrument Placenta Instrument* Adult Microbiome Swab Instrument & Instructions Adult Biospecimen Pick Up Instrument*
Child-Focused Biospecimen Collection - Infant Blood Spot	Child	Infant Blood Spot Instrument Child Biospecimen Pick Up Instrument*
Post-Natal Activities
Infant & Child Health Care Log (Birth to 60M)	Primary Caregiver	Infant & Child Health Care Log
3-Month Interview	Primary Caregiver	3-Month Questionnaire Child 3-Month Questionnaire Adult 3-Month Questionnaire Household 3-Month Questionnaire Biological Mother Ages & Stages (ASQ-3™) SAQ (2-Month or 4-Month) & Phone Instructions Infant Behavior Questionnaire-Revised (IBQ-R) SAQ & Instructions
	Biological Mother	Edinburgh Postnatal Depression Scale SAQ & Instructions
Adult-Focused Biospecimen Collection - Breast Milk, Blood, Urine, Saliva, & Microbiome Swab (3M, 6M, 12M, 24M, 36M, 48M, 60M)	Primary Caregiver	Breast Milk SAQ, Instructions, & Letter Breast Milk Kit Distribution & Pick Up Instrument Adult Blood Instrument Adult Blood Prescreening Questionnaire Adult Urine Instrument & Instructions Adult Saliva Instrument Adult Microbiome Swab Instrument & Instructions
6-Month Interview	Primary Caregiver	6-Month Questionnaire Child 6-Month Questionnaire Adult 6-Month Questionnaire Household 6-Month Infant Feeding SAQ ASQ-3™ SAQ (6-Month or 8-Month), In Person & Mail Instructions Participant Satisfaction SAQ
Core Questionnaire - Child, Adult, & Household (6M to 60M, except 9M)	Primary Caregiver	Core Questionnaire Child Vaccination Grid Module – Core Child Core Questionnaire Adult Core Questionnaire Household
Child-Focused Biospecimen Collection - Urine, Blood, Saliva, Microbiome Swab, & Teeth (6M, 12M, 24M, 36M, 48M, 60M)	Primary Caregiver	Child Urine Instrument, Instructions, & Urine Bag Instructions Child Blood Instrument Child Blood Prescreening Questionnaire Child Saliva Instrument Child Microbiome Swab Instrument Child Microbiome Stool SAQ & Collection Instructions Child Teeth Instrument, SAQ, & Collection Instructions
9-Month Interview	Primary Caregiver	9-Month Questionnaire Child
Father Post-Natal Interview (9M or 18M)	Father/Father Figure	Father Post-Natal Questionnaire Child Father Post-Natal Questionnaire Adult Father Post-Natal Questionnaire Household
12-Month Interview	Primary Caregiver	12-Month Questionnaire Child 12-Month Questionnaire Adult 12-Month Questionnaire Household 12-Month SAQ Child 12-Month SAQ Adult ASQ-3™ SAQ (12-Month or 14-Month or 16-Month), In Person & Mail Instructions Brief Infant Toddler Social Emotional Assessment (BITSEA™) SAQ, In Person, Mail, & Phone Instructions
Child-Focused Physical Measures - Anthropometry, Blood Pressure, Vision Screening, Lung Function, & Motor Skills (6M, 12M, 24M, 36M, 48M, 60M)	Child	NIH Toolbox Visual Acuity Test
	Primary Caregiver	Child Anthropometry Instrument Child Blood Pressure Instrument Lung Function Instrument NIH Toolbox Early Childhood Motor Battery
Environmental Sample Collection - Vacuum Bag Dust, Indoor and Outdoor Visual Observations, & Dust Wipes (12M, 36M, 48M, 60M)	Primary Caregiver	Vacuum Bag Dust Instrument Indoor Dwelling Unit Visual Observations Outdoor Structural Visual Observations* Dust Wipes - Organic & Inorganic
18-Month Interview	Primary Caregiver	18-Month Questionnaire Child 18-Month Questionnaire Adult NIH Toolbox Emotion Battery Modified Checklist for Autism in Toddlers (M-CHAT) SAQ, In Person, & Mail Instructions Personal Assessment of Intimacy in Relationships (PAIR) Questionnaire PAIR SAQ Instructions
24-Month Interview	Primary Caregiver	24-Month Questionnaire Child 24-Month Questionnaire Adult 24-Month Questionnaire Household ASQ-3™ SAQ (24-Month or 27-Month or 30-Month), In Person & Mail Instructions M-CHAT SAQ, In Person, & Mail Instructions
30-Month Interview	Primary Caregiver	30-Month Questionnaire Child 30-Month Questionnaire Adult BITSEA™ SAQ, In Person, Mail, & Phone Instructions Brief Symptom Inventory (BSI®) SAQ &Mail Instructions Infant/Toddler Sensory Profile™ SAQ, Mail, & Phone Instructions
36-Month Interview	Primary Caregiver	36-Month Questionnaire Child 36-Month Questionnaire Adult 36-Month Questionnaire Household 36-Month Questionnaire Child Care Facility ASQ-3™ SAQ (36-Month or 42-Month) & In Person, Mail Instructions SWAN Rating Scale for ADHD SAQ & Instructions Major Life Events SAQ & Instructions Woman Abuse Screening Tool (WAST) SAQ Alcohol, Tobacco, Substance Abuse SAQ
	Child	NIH Toolbox Early Childhood Cognition Battery Home Social Direct Observation Instrument*
42-Month Interview	Primary Caregiver	NIH Toolbox Emotion Battery Dietary Food Frequency SAQ Participant Satisfaction SAQ
	Biological Mother, Biological Father	Chronic Medical History SAQ Family Medical History SAQ & Supplemental SAQ
48-Month Interview	Primary Caregiver	48-Month Questionnaire Child 48-Month Questionnaire Adult 48-Month Questionnaire Household 48-Month Questionnaire Child Care Facility NIH Toolbox Cognition Battery ASQ-3™ SAQ (48-Month or 54-Month), In Person & Mail Instructions NIH Toolbox Parent Proxy Emotion Battery Participant Engagement & Motivation SAQ
54-Month Interview	Primary Caregiver	54-Month Questionnaire Child 54-Month Questionnaire Adult Dietary Food Frequency SAQ
60-Month Interview	Primary Caregiver	60-Month Questionnaire Child 60-Month Questionnaire Adult 60-Month Questionnaire Household 60-Month Questionnaire Child Care Facility ASQ-3™ SAQ 60-Month, In Person & Mail Instructions SWAN Rating Scale for ADHD SAQ & Instructions Major Life Events SAQ & Instructions
	Child	NIH Toolbox Early Childhood Cognition Battery
Subsample Studies
Noise (36M, 60M)	Primary Caregiver	Noise Measurement SAQ, Set Up, & Pick Up Instrument Environmental Noise Monitor & Shipping Instructions
Bioelectrical Impedance Analysis (BIA) (48M, 60M)	Primary Caregiver	BIA Instrument
Physical Activity (Accelerometer) (36M, 48M, 60M)	Primary Caregiver	Physical Activity Monitor SAQ, Log, Set Up, & Pick Up Instrument Environmental Physical Activity Monitor, Shipping, & GPS Instructions

Consents

Pregnant Woman

Adult

Father & Parental Partner

Parental Permission for Child’s Participation – Birth to 6 Months of Age

Parental Permission for Child’s Participation – 6 Month Visit to Age of Majority

Multi-Mode Visit Information Script

Sample Collection Visit Information Sheet Scripts

Reconsideration Instrument Child & Adult

HIPAA Authorization for Use and Disclosure of Health Information

HIPAA Authorization to Obtain Bodily Fluids and Tissues

Authorization Form for Release of Child Death Certificate

Authorization Form for Release of Parent/Guardian Death Certificate

Authorization for Release of Health-Related Birth Certificate

* Data Collector only, no participant burden.