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Project Title:

Design of the National Children’s Study and Implications for the Generalizability of Results
PIN: DBASSE-CNSTAT-13-07        

Major Unit:

Division of Behavioral and Social Sciences and Education
Institute of Medicine

Sub Unit: Board on Children, Youth, and Families
Committee on National Statistics

RSO: Kirkendall, Nancy

Subject/Focus Area: Behavioral and Social Sciences; Health and Medicine

Project Scope
An ad hoc panel will conduct a congressionally mandated review of the design of the National Children's Study (NCS) Main Study. The NCS is intended to follow a cohort of 100,000 children identified at or before birth through age 21 years. The study consists of a pilot or Vanguard Study, currently under way, and a Main Study, which is not to begin until after the expert panel has delivered its report. Based on Vanguard Study experience and other input, as of the meeting of the NCS Federal Advisory Committee on February 26, 2013, the National Institute of Child Health and Human Development (NICHD) proposed a multi-stage probability design for 90 percent of the expected sample size of children for the Main Study. The first stage would select a national probability sample of hospitals and birthing centers from a national listing. A second stage would list prenatal care providers that “feed” patients for delivery at the selected hospital or birthing center, and a third stage would attempt to recruit pregnant women seeing these providers during their prenatal period. In addition, some women may need to be enrolled at the hospital at delivery. The remaining 10 percent of the Main Study sample is set aside for targeted populations for addressing additional questions of scientific interest, including subsequent births to women selected into the probability sample. The children enrolled in the Main Study will have a wide range of data collected about them, their parents, and their environment at specified intervals over the life of the study.

The charge to the expert panel is to review this proposed design with regard to the sampling frame, the sample design, the recruitment and retention process, and broad aspects of the interview schedule and data collection procedures to determine their scientific merit and, in particular, to determine the expected generalizability of results to a national population and population groups. The panel's review will cover such aspects of the Main Study design as the national probability sample's overall sample size and design; the use of hospitals and birthing centers as the primary sampling unit; relative size of the prenatal and birth strata in the probability sample; the size of the supplemental convenience sample; optimal use of sibling births; use of health care providers to refer prospective participants; proposed study visit schedule, with emphasis on more frequent data collection in pregnancy and early childhood; proposed approach to assess health and developmental phenotypes; and proposed approach to define and characterize health disparities. The panel will deliver a report with conclusions and recommendations at the end of the study that take cognizance of logistical and resource constraints as provided by NICHD.

The project is sponsored by the U.S. Department of Health and Human Services.

The approximate start date for the project is June 3, 2013.

A report will be issued at the end of the project in approximately 15 months.

Project Duration: 15 months    

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Committee Membership
Committee Membership

 Meeting 1 - 08/15/2013
 Meeting 2 - 10/31/2013
 Meeting 3 - 01/23/2014


Reports having no URL can be seen
at the Public Access Records Office
The National Children's Study 2014: An Assessment