Attach. 2 Instruments by Event and Stage of OMB Review

Attach. 2 Instruments by Event and Stage of OMB Review As of May152014.docx

Continuation of National Children's Study Vanguard (Pilot) Study Data Collection: Study Visits through 60-Months

Attach. 2 Instruments by Event and Stage of OMB Review

OMB: 0925-0593

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Attachment 2: NCS Vanguard Study Instruments by Event & Stage of OMB Review & Approval

(As of May 15, 2014)


Note: Instruments in italics are not yet approved by OMB for fielding.

Pre

Pregnancy

Pregnancy Visit 1

Pregnancy

Visit 2

Birth

3 Mo

6 Mo

9 Mo

12 Mo

18 Mo

24 Mo

30 Mo

36 Mo

42 Mo

48 Mo

54 Mo

60 Mo

Assessment Type

Pregnancy Screener


















Pregnancy Screener - Sibling Birth Cohort







3

3

3

3

3

3

3

3

3

3

Questionnaire

Retrospective Pregnancy Screener




3

3

3











Questionnaire

Biospecimen Collection














Child-Focused














Infant Blood Spot




3*













Sample

Microbiome Swab






2




2




2



Sample

Urine






2*


2*




1*




2*

Sample

Blood








2*




1*




2*

Sample

Saliva








2*




1*




2*

Sample

Baby Teeth
















2

Sample

Adult-Focused














Blood

3*

3*

3*

3*


2*


2*




1*




2*

Sample

Urine

3*

3*

3*

3*


2*


2*




1*




2*

Sample

Microbiome Swab




3^


2




2




2



Sample

Saliva












1*




2*

Sample

Cord Blood




3*













Sample

Placenta




3*













Sample

Breast Milk




3*

2*












Sample

Environmental Measures














Vacuum Bag Dust


3*






2*




1*


2*


2*

Sample

Indoor Dwelling Unit Visual Observations








2^




1


2^


2^

Interviewer Observation

Outdoor Structural Visual Observations








2^




1


2^


2^

Interviewer Observation

Dust Wipes












1*


2*


2*

Sample

Noise (Subsample Study)












3




3

Sample

Physical Measures














Child Anthropometry






2*


2*


2*


1*


2*


2*

Direct Measurement

Child Blood Pressure








2*


2*


1*


2*


2*

Direct Measurement

NIH Toolbox Visual Acuity Test












1




2^

Direct Measurement

Lung Function
















2

Direct Measurement

NIH Toolbox Early Childhood Motor Battery
















2

Direct Measurement

BIA (Subsample Study)














3


3

Direct Measurement

Physical Activity (Subsample Study)












3


3


3

Direct Measurement

Neuro-Psychosocial Measures














NIH Toolbox Emotion Battery


3^







2^




1




Scored Assessment

Ages & Stages-3 (ASQ-3TM) SAQ





2*

2*


2*


2*


1*


2*


2*

Scored Assessment

Edinburgh Postnatal Depression Scale SAQ





2












Scored Assessment

Infant Behavior Questionnaire -Revised (IBQ-R) SAQ





2












Scored Assessment

Brief Infant Toddler Social Emotional Assessment (BITSEA™) SAQ








2*



1*






Scored Assessment

Personal Assessment of Intimacy in Relationships (PAIR) SAQ









2








Scored Assessment

Modified Checklist for Autism in Toddlers (M-CHAT) SAQ









2*

2*







Scored Assessment

Brief Symptom Inventory (BSI®) SAQ











1*






Scored Assessment

Infant/Toddler Sensory Profile™ SAQ











1*






Scored Assessment

NIH Toolbox Early Childhood Cognition Battery












1




2^

Scored Assessment

SWAN Rating Scale for ADHD SAQ












1




2^

Scored Assessment

Home Social Direct Observation (Data Collector Only)












1





Questionnaire

Major Life Events SAQ












1




2^

Scored Assessment

NIH Toolbox Cognition Battery














2



Scored Assessment

NIH Toolbox Parent Proxy Emotion Battery














2



Scored Assessment

Questionnaires/Assessments














Age-Specific Questionnaires














Child




3*

2*

2*

2*

2*

2*

2*

1*

1

1

2

2

2

Questionnaire

Adult

3*

3*

3*

3*

2*

2*


2*

2*

2*

1*

1


2

2

2

Questionnaire

Household

3*

3*

3*

3*

2*

2*


2*


2*


1


2


2

Questionnaire

Biological Mother





2*












Questionnaire

Child Care Facility












1


2


2

Questionnaire

Core Questionnaires














Child






2*


2*

2*

2*

1*

1*

1*

2*

2*

2*

Questionnaire

Adult






2*


2*


2*


1*


2*


2*

Questionnaire

Household






2*


2*

2*

2*

1*

1*

1*

2*

2*

2*

Questionnaire

Participant Verification & Tracing (PVT) Instrument


3*

3*

3*

2*

2*

2*

2*

2*

2*

1*

1*

1*

2*

2*

2*

Questionnaire

Parent-Caregiver Death Questionnaire





2^

2^

2^

2^

2^

2^

1

1

1

2^

2^

2^

Questionnaire

Child Death Questionnaire





2^

2^

2^

2^

2^

2^

1

1

1

2^

2^

2^

Questionnaire

Pregnancy Loss, Stillbirth, & Neonatal Death Questionnaire


3*

3*

3*













Questionnaire

Validation Questionnaire

3*

3*

3*

3*

2*

2*

2*

2*

2*

2*

1*

1*

1*

2*

2*

2*

Questionnaire

Non-Interview Respondent SAQ

3*

3*

3*

3*

2*

2*

2*

2*

2*

2*

1*

1*

1*

2*

2*

2*

Questionnaire

Infant & Child Health Care Log




3*

2*

2*

2*

2*

2*

2*

1*

1*

1*

2*

2*

2*

Recall Tool

Pregnancy Health Care Log


3*

3*














Recall Tool

Participant Satisfaction SAQ






2^







1




Questionnaire

Secondary Residence





2^

2^

2^

2^

2^

2^

1

1

1

2^

2^

2^

Questionnaire

Woman Abuse Screening Tool (WAST) SAQ












1





Questionnaire

Alcohol, Tobacco, Substance Abuse SAQ












1





Questionnaire

Dietary Food Frequency SAQ













1


2^


Questionnaire

Chronic Medical History SAQ













1




Questionnaire

Family Medical History SAQ













1




Questionnaire

Participant Engagement & Motivation SAQ














2



Questionnaire

Interview Observation Questionnaire – Child, Adult, & Household (Data Collector Only)

3^

3^

3^

3^

2^

2^

2^

2^

2^

2^

1

1

1

2^

2^

2^

Questionnaire

Pregnancy Probability Group Follow-Up Questionnaire

3*
















Questionnaire

Father Pre-Natal Questionnaire - Adult & Household


3*

3*














Questionnaire

Infant Feeding SAQ






3*











Questionnaire

Father Post Natal Questionnaire – Child, Adult, & Household







2


2








Questionnaire

Other














Participant Information Update - Incentive Substudy










3

3

3

3

3

3

3

Questionnaire

Informed Consent Documents














Pregnant Woman


2*

2*














Consent

Adult





2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

Consent

Father and Parental Partner


2*

2*














Consent

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


2

2

2













Consent

Parental Permission for Child’s Participation - 6 Months to Age of Majority






2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

Consent

Multi-Mode Visit Information Sheet

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

2*

Consent

Sample Collection Visit Information Sheet

2*

2*

2*

2*


2*


2*


2*


2*


2*


2*

Consent

Reconsideration Instrument – Child & Adult

2*

2*

2*



2*


2*


2*


2*


2*


2*

Consent

HIPAA Authorization for Use and Disclosure of Health Information

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

Consent

HIPAA Authorization to Obtain Bodily Fluids & Tissues


2*

2*

2*













Consent

Authorization Form for Release of Child Death Certificate




2

2

2

2

2

2

2

2

2

2

2

2

2

Consent

Authorization Form for Release of Parent/Guardian Death Certificate

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

2

Consent

Authorization for Release of Health-Related Birth Certificate




2













Consent



* Indicates that specific data collection was approved by OMB as part of a previous Information Collection request.

^ Indicates that approval for specific data collection is requested as part of an earlier Stage for a different Study visit. 98

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