Establishing how prenatal opioid exposure impacts brain development, as well as short- and long- term cognitive, behavioral, social, and emotional function, is challenging due to confounding by myriad factors, including other adverse childhood experiences. Our proposed ?Florida - Development in Early Childhood: Adversity and Drug Exposure (FL-DECADE)? study, sampled from the 3rd most populous state, diverse in socioeconomic status, race/ethnicity, and rurality/urbanicity, will determine the feasibility of a multifaceted approach to recruitment of normal and high-risk pregnant women and their children across this large, diverse state. If successful, a subsequent Florida cohort using this strategy will provide the ability to appropriately account for confounding and identify factors associated with resiliency. Three inter-related tasks will support this comprehensive feasibility study. First, an interdisciplinary summit will occur early in the study, focused on how best to mitigate risks and maximize benefits to children and families recruited in a future cohort. This goal-oriented conference of leaders in multiple fields will provide a thorough understanding of the legal, ethical, and pragmatic considerations for effectively recruiting and retaining families in longitudinal research whose children are at high risk. Second, the feasibility of a multi-faceted three-pronged recruitment strategy will be assessed: 1) representative recruitment through a large state-wide clinical research consortium, 2) oversampling of pregnant women who use opioids through community engagement programs, and 3) respondent-driven sampling to target recruitment of pregnant women who use opioids who are not in treatment. Third, select pregnancy and birth assessments will be collected from recruited participants in this feasibility study, while leveraging data across early childhood from existing resources, to inform Phase II study planning. This Phase I of the FL-DECADE study will provide valuable planning and feasibility data to be used for the national efforts to build a large, prospective cohort. This FL- DECADE study will contribute important information on optimal sampling and retention strategies of a diverse group of families. The characterization of substance-use patterns among pregnant women across a large state will assist in the development of statewide recruitment strategies. Evaluating the ability to obtain imaging and other measures at birth, including among substance- exposed infants, will add to the overall feasibility assessment. Finally, the utility of innovative, state-wide linked data sources to supplement cohort data collection (and reduce participant burden) will be determined. By building on a host of strong resources, the FL-DECADE study will be able to determine feasibility and provide insight for the planning of a large, prospective cohort.
Establishing developmental trajectories of children beginning in utero, while determining the impact of prenatal drug exposures and adverse childhood experiences, requires a team ready to address the legal/ethical issues surrounding recruitment and retention, and who can develop innovative recruitment, sampling, and assessment strategies. The proposed ?Florida Development in Early Childhood: Adversity and Drug Exposure (FL-DECADE)? study will create a pathway to a long-term cohort built on ethical foundations, a comprehensive recruitment strategy, and leveraging existing big data resources. With a strong, existing infrastructure in the third most populous state, and researchers and community partners dedicated to understanding adversity and the developing brain, the FL-DECADE study is poised to determine feasibility of a long-term prospective study that helps address this topic of vital importance.
