Recruitment Strategy Substudy for the National Children's Study (NICHD)

ICR 201101-0925-004

OMB: 0925-0593

Federal Form Document

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Supplementary Document
2010-12-30
Supplementary Document
2010-12-30
Supplementary Document
2010-12-30
Justification for No Material/Nonsubstantive Change
2010-12-30
Supplementary Document
2010-06-07
Supplementary Document
2010-06-07
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2010-06-07
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2010-06-15
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2010-06-07
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2010-06-07
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2010-06-15
IC Document Collections
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193580 Modified
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ICR Details
0925-0593 201101-0925-004
Historical Active 201012-0925-006
HHS/NIH
Recruitment Strategy Substudy for the National Children's Study (NICHD)
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 01/19/2011
Retrieve Notice of Action (NOA) 01/18/2011
Prior terms continue.
  Inventory as of this Action Requested Previously Approved
07/31/2013 07/31/2013 07/31/2013
390,068 0 390,068
128,042 0 128,042
0 0 0

The Initial Vanguard Study protocol was designed to enroll approximately 1,750 pregnant women through seven study locations after 12 months of data collection. Two of the locations began recruitment in January 2009 and the remaining 5 in April 2009. As of May 2010, however, approximately 900 pregnant women have been enrolled, leading to questions about the assumptions underlying the Initial Vanguard Study recruitment model. The seven Initial Vanguard sites use a household enumeration and screening strategy to identify eligible women for recruitment into the study. Although household enumeration is often considered a gold standard for maximizing coverage, in that all dwelling units are identified and enumerated, for the NCS Initial Vanguard Study this method has not yielded the target number of births in the time frame projected from initial models. Consequently, additional methodological research is needed to evaluate the feasibility, acceptability, and cost of alternate recruitment strategies for enrollment of pregnant women into the NCS. This research will be conducted through the NCS Recruitment Substudy. The Recruitment Substudy will assess three alternate recruitment strategies - (1) a provider-based recruitment strategy; (2) an enhanced version of a household enumeration strategy; and (3) a two-tier recruitment strategy involving high-intensity and low-intensity data collection efforts.

PL: Pub.L. 106 - 310 1004 Name of Law: Childrens Health Act of 2000
  
None

Not associated with rulemaking

Yes

30
IC Title Form No. Form Name
Enhanced Household: Pre-pregnancy Interview 4 Survey
Enhanced Household: Pregnancy Probability Group Follow Up Script 5.1, 5.2 Survey ,   Survey
Provider-Based: Pregnancy Visit 2 Interview 7 Survey
Provider-Based: Birth Visit Interview 8 Survey
Provider-Based: Women's Informed Consent Form 3.1 Consent
Provider-Based: Pregnancy Visit 1 Interview 6 Survey
Enhanced Household: Neighbor Report 10 Form
Enhanced Household: Women's Informed Consent Form 3.1 Consent
Enhanced Household: Pregnancy Visit 1 Interview 6 Survey
Two Tier (Low): Low-Intensity CATI Pregnancy Screener 2.2 Survey
Two Tier (Low): Low-Intensity Consent Script 3.2, 3.3 Consent ,   Consent
Enhanced Household: Pregnancy Visit 2 Interview 7 Survey
Enhanced Household: Birth Visit Interview 8 Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women) 9 Survey
Two Tier (Low): Pregnancy Probability Group Follow Up Script 5.2, 5.1 Survey ,   Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities) 9 Survey
Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities) 9 Survey
Two Tier (High): Pregnancy Screening 2 Survey
Two Tier (High): Pre-Pregnancy Interview 4 Survey
Two Tier (High): Women's Informed Consent Form 3.1 Consent
Two Tier (High): Pregnancy Visit 1 Interview 6 Survey
Two Tier (High): Pregnancy Probability Group Follow Up Script 5.1, 5.2 Survey ,   Survey
Two Tier (High): Pregnancy Visit 2 Interview 7 Survey
Two-Tier (High): Birth Visit Interview 8 Survey
Enhanced Household: Household Enumeration Script 1 Survey
Enhanced Household: Pregnancy Screening 2 Survey
Provider-Based: Address Look-Up
Provider-Based: Pregnancy Screening 2.3 Survey
Provider-Based: Pre-Pregnancy Visit 4 Survey
Provider-Based: Pregnancy Probability Group Follow Up Script 5.1, 5.2 Survey ,   Survey

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 390,068 390,068 0 0 0 0
Annual Time Burden (Hours) 128,042 128,042 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$110,000,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Mikia Currie 3014350941

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
01/18/2011


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