Information Collection Request

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

ICR 201007-0925-001 · OMB 0925-0593 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form 8 Two-Tier (High): Birth Visit Interview Form and Instruction New Repair queued
Form 7 Two Tier (High): Pregnancy Visit 2 Interview Form and Instruction New Repair queued
Form 6 Two Tier (High): Pregnancy Visit 1 Interview Form and Instruction New Available
Form 3.1 Two Tier (High): Women's Informed Consent Form Form and Instruction New Available
Form 5.1 Two Tier (High): Pregnancy Probability Group Follow Up Script Form and Instruction New Repair queued
Form 4 Two Tier (High): Pre-Pregnancy Interview Form and Instruction New Repair queued
Form 2 Two Tier (High): Pregnancy Screening Form and Instruction New Repair queued
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities) Form and Instruction New Repair queued
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities) Form and Instruction New Repair queued
Form 5.2 Two Tier (Low): Pregnancy Probability Group Follow Up Script Form and Instruction New Repair queued
Form 9 Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women) Form and Instruction New Repair queued
Form 3.2 Two Tier (Low): Low-Intensity Consent Script Form and Instruction New Repair queued
Form 2.2 Two Tier (Low): Low-Intensity CATI Pregnancy Screener Form and Instruction New Available
Form 8 Enhanced Household: Birth Visit Interview Form and Instruction New Available
Form 7 Enhanced Household: Pregnancy Visit 2 Interview Form and Instruction New Repair queued
Form 6 Enhanced Household: Pregnancy Visit 1 Interview Form and Instruction New Repair queued
Form 3.1 Enhanced Household: Women's Informed Consent Form Form and Instruction New Available
Form 5.1 Enhanced Household: Pregnancy Probability Group Follow Up Script Form and Instruction New Repair queued
Form 4 Enhanced Household: Pre-pregnancy Interview Form and Instruction New Available
Form 10 Enhanced Household: Neighbor Report Form New Repair queued
Form 8 Provider-Based: Birth Visit Interview Form and Instruction New Repair queued
Form 7 Provider-Based: Pregnancy Visit 2 Interview Form and Instruction New Repair queued
Form 6 Provider-Based: Pregnancy Visit 1 Interview Form and Instruction New Repair queued
Form 3.1 Provider-Based: Women's Informed Consent Form Form and Instruction New Available
Form 5.2 Provider-Based: Pregnancy Probability Group Follow Up Script Form and Instruction New Available
Form 4 Provider-Based: Pre-Pregnancy Visit Form and Instruction New Repair queued
Form 2.3 Provider-Based: Pregnancy Screening Form and Instruction New Repair queued
Form C.10.5 Child Care Providers Form and Instruction Removed Available
Form C.9.4 Community Leaders Form and Instruction Removed Repair queued
Form C.9.3 Health Care Providers Form and Instruction Removed Repair queued
Form A.2.3.f Fathers Form and Instruction Removed Repair queued
Form 1 Postnatal Activities - Mother and Children Form and Instruction Removed Repair queued
Form A.2.3.L5 Birth Activities-Mother and Children Form and Instruction Removed Repair queued
Form 1 Pregnancy Activities Form and Instruction Removed Available
Form A.1.2.b Low Probability Women Form and Instruction Removed Repair queued
Form A.1.2.b Moderate Probability Women Form and Instruction Removed Available
Form A.1.2.b High Probability Women w/o Pre-pregnancy Visit Form and Instruction Removed Repair queued
Form 1 High Probability Women w/Pre-pregnancy Visit Form and Instruction Removed Repair queued
Form 2 Enhanced Household: Pregnancy Screening Form and Instruction Modified Repair queued
Form 1 Enhanced Household: Household Enumeration Script Form and Instruction Modified Repair queued
Supporting Statement Part B 20100714.docx Supporting Statement B Uploaded 2010-07-15 Available
List of NCS Instruments, by Recruitment Strategy (July Launch).docx Supplementary Document Uploaded 2010-06-15 Repair queued
Itemized Burden Estimate.docx Supplementary Document Uploaded 2010-06-14 Available
Birth Visit July Launch VIS 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document Uploaded 2010-06-07 Repair queued
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document Uploaded 2010-06-15 Repair queued
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Birth Visit July Launch VIS 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document Uploaded 2010-06-15 Available
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Repair queued
Birth Visit July Launch VIS 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 2 July Launch Visit Information Sheet 20100607.pdf Supplementary Document Uploaded 2010-06-07 Available
Pregnancy Visit 1 July Launch Visit Information Sheet 20100607.docx Supplementary Document Uploaded 2010-06-07 Available
Pre--pregnancy interview July Launch VIS 20100615.pdf Supplementary Document Uploaded 2010-06-15 Available
Supporting Statement Part A 20100604.docx Supporting Statement A Uploaded 2010-06-14 Available
IC Document Collections
IC IDCollectionTypeStatusForm
193580 Two-Tier (High): Birth Visit Interview Form and Instruction New
193579 Two Tier (High): Pregnancy Visit 2 Interview Form and Instruction New
193578 Two Tier (High): Pregnancy Visit 1 Interview Form and Instruction New
193577 Two Tier (High): Women's Informed Consent Form Form and Instruction New
193576 Two Tier (High): Pregnancy Probability Group Follow Up Script Form and Instruction New
193575 Two Tier (High): Pre-Pregnancy Interview Form and Instruction New
193574 Two Tier (High): Pregnancy Screening Form and Instruction New
193573 Two Tier (Low): Low-Intensity CATI Questionnaire (Birth-Related Activities) Form and Instruction New
193572 Two Tier (Low): Low-Intensity CATI Questionnaire (Pregnancy Activities) Form and Instruction New
193571 Two Tier (Low): Pregnancy Probability Group Follow Up Script Form and Instruction New
193570 Two Tier (Low): Low-Intensity CATI Questionnaire (Age-Eligible Women) Form and Instruction New
193569 Two Tier (Low): Low-Intensity Consent Script Form and Instruction New
193568 Two Tier (Low): Low-Intensity CATI Pregnancy Screener Form and Instruction New
193567 Enhanced Household: Birth Visit Interview Form and Instruction New
193566 Enhanced Household: Pregnancy Visit 2 Interview Form and Instruction New
193565 Enhanced Household: Pregnancy Visit 1 Interview Form and Instruction New
193564 Enhanced Household: Women's Informed Consent Form Form and Instruction New
193563 Enhanced Household: Pregnancy Probability Group Follow Up Script Form and Instruction New
193562 Enhanced Household: Pre-pregnancy Interview Form and Instruction New
193561 Enhanced Household: Neighbor Report Form New
193560 Provider-Based: Birth Visit Interview Form and Instruction New
193559 Provider-Based: Pregnancy Visit 2 Interview Form and Instruction New
193558 Provider-Based: Pregnancy Visit 1 Interview Form and Instruction New
193557 Provider-Based: Women's Informed Consent Form Form and Instruction New
193556 Provider-Based: Pregnancy Probability Group Follow Up Script Form and Instruction New
193555 Provider-Based: Pre-Pregnancy Visit Form and Instruction New
193554 Provider-Based: Pregnancy Screening Form and Instruction New
193553 Provider-Based: Address Look-Up Instruction New
184283 Child Care Providers Form and Instruction Removed
184282 Community Leaders Form and Instruction Removed
184281 Health Care Providers Form and Instruction Removed
184280 Fathers Form and Instruction Removed
184279 Postnatal Activities - Mother and Children Form and Instruction Removed
184278 Birth Activities-Mother and Children Form and Instruction Removed
184277 Pregnancy Activities Form and Instruction Removed
184276 Low Probability Women Form and Instruction Removed
184275 Moderate Probability Women Form and Instruction Removed
184274 High Probability Women w/o Pre-pregnancy Visit Form and Instruction Removed
184273 High Probability Women w/Pre-pregnancy Visit Form and Instruction Removed
184272 Enhanced Household: Pregnancy Screening Form and Instruction Modified
184271 Enhanced Household: Household Enumeration Script Form and Instruction Modified
ICR Details
0925-0593 201007-0925-001
Historical Active 200803-0925-005
HHS/NIH
Recruitment Strategy Substudy for the National Children's Study (NICHD)
Revision of a currently approved collection   No
Regular
Approved with change 07/23/2010
Retrieve Notice of Action (NOA) 07/02/2010
Previous terms of clearance remain in effect.
  Inventory as of this Action Requested Previously Approved
07/31/2013 36 Months From Approved 09/30/2011
390,068 0 64,598
128,042 0 13,797
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

  75 FR 14165 03/24/2010
75 FR 35042 06/21/2010
Yes

30
IC Title Form No. Form Name
High Probability Women w/o Pre-pregnancy Visit A.1.2.b Survey
Two-Tier (High): Birth Visit Interview 8 Survey
High Probability Women w/Pre-pregnancy Visit 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1 Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Pregnancy Activities 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1 Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Moderate Probability Women A.1.2.b Survey
Low Probability Women A.1.2.b Survey
Provider-Based: Women's Informed Consent Form 3.1 Consent
Provider-Based: Pregnancy Visit 1 Interview 6 Survey
Provider-Based: Pregnancy Visit 2 Interview 7 Survey
Provider-Based: Birth Visit Interview 8 Survey
Provider-Based: Pregnancy Probability Group Follow Up Script 5.1, 5.2 Survey ,   Survey
Enhanced Household: Neighbor Report 10 Form
Enhanced Household: Pre-pregnancy Interview 4 Survey
Birth Activities-Mother and Children A.3.2, A.2.1.h, A.2.3.L5, A.1.1.a, A.1.1.c Survey ,   Survey ,   Survey ,   Survey ,   Survey
Two Tier (High): Pregnancy Visit 2 Interview 7 Survey
Enhanced Household: Pregnancy Probability Group Follow Up Script 5.1, 5.2 Survey ,   Survey
Enhanced Household: Women's Informed Consent Form 3.1 Consent
Postnatal Activities - Mother and Children 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1, 1 Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survery ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Fathers A.2.3.f, A.1.3.b, A.2.2.a, A.2.2.b, A.2.2.c, A.2.2.d, A.2.2.e, A.2.3.b3, A.2.3.f, A.2.3.i, A.2.3.i, A.3.1, A.3.3, A.2.3.j1, A.2.3.j2, A.2.3.j3, A.2.3.L3, A.2.3.m1 Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey ,   Survey
Health Care Providers A.2.1, A.2.3, C.9.3 Instruments ,   Instruments ,   Instruments
Community Leaders C.9.4 Instruments
Child Care Providers C.10.5 Instruments
Enhanced Household: Pregnancy Visit 2 Interview 7 Survey
Enhanced Household: Birth Visit Interview 8 Survey
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
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): Pregnancy Probability Group Follow Up Script 5.1, 5.2 Survey ,   Survey
Two Tier (High): Women's Informed Consent Form 3.1 Consent
Two Tier (High): Pregnancy Visit 1 Interview 6 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

  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 64,598 0 325,470 0 0
Annual Time Burden (Hours) 128,042 13,797 0 114,245 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
Yes
Miscellaneous Actions
The NCS Initial Vanguard Study, which consists of 7 Study locations, utilized the Household Enumeration and Screening Strategy, but did not yield the target number of births in the time frame projected from initial models. As a result, 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. Each recruitment approach would occur in 10 study locations, for a total of 30 study locations implementing alternate recruitment strategies. Recruitment strategies will be assessed and compared on the basis of feasibility (including success in recruiting and retaining sufficient numbers of participants), acceptability (including the extent of selection bias in recruitment, effect on respondent burden, and impact on study infrastructure), and cost. Ultimately, these comparisons will inform the recruitment approach or approaches to be taken for the NCS Main Study. Each recruitment strategy will be provided with approximately equally resources, and will be associated with a specific communications theme appropriate for its mode of participant enrollment.

$110,000,000
Yes Part B of Supporting Statement
No
No
Uncollected
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.
07/02/2010