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. Additionally, retention and selected study visit
assessments will be evaluated to inform study logistics and
measures to be used in the Main Study.
This request for revision
proposes the addition of a Recruitment Substudy to the Initial
Vanguard Study to better inform the design and implementation of
the Main Study. Additionally, we request that eligibility of women
in the Initial Vanguard Study be extended to include women who
resided in the geographically-eligible locations at recruitment,
but who subsequently moved residence outside of a
geographically-eligible location prior to the sample child's birth.
We estimate that this extension of the eligibility criteria
pertains to very few women, but it would be advantageous to the
study by maintaining good will with participants and supporting
analysis on instrument functionality. Since the Initial Vanguard
Study is not designed to yield national rates, expanding inclusion
criteria in this small way would not impair the ability of the
study to meet its objectives.
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.
Form 84.2 Two-Tier (Low): Low-Intensity Questionnaire (Child-focus)
Supporting Statement Part B 20110211.docx
List of Instruments for Phase 1 and 2, NCS Vanguard (Pilot) Study.xlsx
Two-Tier (Low): Low-Intensity Questionnaire (Child-focus)