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 Methods Development and Pilot Studies

Pilot studies will be conducted throughout the life of the National Children’s Study as new issues and challenges arise, and will encompass questions that must be addressed to enable a functional and cost-effective Study. As results from the pilot studies become available, they will be incorporated into the research design for the Main Study.

The National Children’s Study had expanded the scope of activity of the Vanguard Study in order to accelerate development and deployment of the Main Study. The goals are to evaluate alternative strategies for recruitment, Study visit assessments, and Study logistics and operations.

Three additional recruitment pilot strategies were developed for implementation during this expanded Vanguard Study. The new strategies included:

  • Provider-based Recruitment
  • Enhanced Household-based Recruitment
  • High Intensity/Low Intensity Dynamic Model

Provider-based Recruitment

Provider-based recruitment utilized health care providers, as broadly defined, to include state licensed practitioners that are in contact with women who are or may become pregnant. Providers included obstetricians, gynecologists, family practitioners, internists, pediatricians, other medical specialists and subspecialists, midwives, public health nurses, or other professionals in a public health clinic setting. The strategy used individuals or locations where health care services are provided as a primary point of contact and to provide information about the National Children’s Study.

Enhanced Household-based Recruitment

Enhanced household-based recruitment utilized field workers who enter the predefined geographic segments and contact individuals and families at their residence. The strategy was similar to that used by the initial seven Vanguard Centers, but was enhanced through application of best practices from their experience; targeted marketing campaigns; enhancement of additional sources of referral into the Study, such as health care providers, social clubs and organizations, and public events; and streamlined enrollment procedures.

High Intensity/Low Intensity Dynamic Model

The High Intensity/Low Intensity Dynamic Model used marketing, direct mail, and other referral techniques to enroll a broad-based population in additional larger geographic areas, such as complete zip codes beyond the predefined geographic segments, into a Low Intensity National Children’s Study. The Low Intensity National Children’s Study will provide participants with Web-based, mail-in, or telephone-based brief questionnaires on a periodic basis. From the pool of participants in the Low Intensity National Children’s Study, those living in the predefined geographic segments were invited to participate in the High Intensity National Children’s Study, which will follow the protocol-based planned Study visit schedule that includes home and clinic visits. If participants left the High Intensity National Children’s Study or declined further participation, new participants from the Low Intensity pool were added dynamically.

Types of Additional Research

With the re-direction of the Vanguard Study, there are now formalized types of methods development studies to occur during the Vanguard phase for the purpose of informing the Main Study regarding methodological issues. The list below and the Types of Additional Research chart (PDF 73KB) delineate Formative Research, Substudies, and Supplemental Methodological Studies, which apply to the Vanguard phase, and includes as well Adjunct Studies, which apply to the Main Study.

  • Formative Research: Focused studies supporting the Vanguard phase, initiated by the Program Office and funded by the National Children’s Study. If they involve National Children’s Study participants and/or laboratory materials, they are referred to as Substudies.

  • Substudies: Focused studies supporting the Vanguard phase, which are initiated by the Program Office and funded by the National Children’s Study. They utilize National Children’s Study participants and/or laboratory materials and will generally be implemented at Study locations.

  • Supplemental Methodological Studies: Focused studies supporting the Vanguard phase, which are initiated, developed, and funded outside of the Study protocol planning efforts. They, too, utilize National Children’s Study participants and/or laboratory materials, and will generally be implemented at Study locations.

  • Adjunct Studies: Focused studies supporting the Main Study, which are initiated, developed, and funded outside of the Study protocol planning efforts. They utilize National Children’s Study participants and/or laboratory materials, and will generally be implemented at Study locations.

  • Repository Research: Focused studies supporting the development of a National Children’s Study repository for stored environmental and biological samples. A summary report and recommendations of an independent expert panel may be found here. The panel was composed of past or present officers of the International Society of Biological and Environmental Repositories (ISBER). The ISBER panel addressed the National Children’s Study approach to development of a repository function for the National Children’s Study.
  11/2/2012
  11/2/2012