4/6 Planning for the HEALthy Early Development Study

Abstract: The Planning for the HEALthy Early Development Study will contribute to the design andrecommended protocol for a future large-scale, multi-site research study to prospectively examinehuman brain, cognitive, behavioral, social and emotional development of children beginningprenatally through ages 9-10, and to determine the impact of maternal pre- and postnatalsubstance use on short- and long-term development of children. The Planning Study will linkinvestigators across 6 research sites who have complementary experience and expertise in theareas that are essential to designing the study. Planning activities will be accomplished using acoordinated set of 10 Working Groups who will work collaboratively to design a sampling andrecruitment strategy for a future large-scale study, to identify and recommend strategies foraddressing the challenges to ethical recruitment and retention of vulnerable populations, and todevelop and test a common protocol for neuroimaging, infant and child assessments, exposureassessment, biospecimen collection, and integration of novel technologies. By the end of thePlanning Phase, the 6 Consortium sites will have produced and tested a recommended protocolfor the future multi-site study, and will have established feasibility of carrying out the study protocolat each of the 6 linked sites.