Florida Development in Early Childhood: Adversity and Drug Exposure (FL-DECADE) Study

项目总结 确定产前阿片类药物暴露如何影响大脑发育，以及短期和长期- 术语认知、行为、社交和情感功能，由于混淆了 无数因素，包括其他不利的童年经历。我们提议的“佛罗里达-- 儿童早期发展：逆境与药物暴露(FL-十年)“研究，抽样 来自人口第三多的州，在社会经济地位、种族/民族和 乡土性/都市性，将决定采用多方面方法招聘正常人的可行性 以及这个庞大、多样化的州的高危孕妇和她们的孩子。如果成功，则会出现一个 随后的佛罗里达队列使用这一策略将提供适当解释的能力 混淆并确定与弹性相关的因素。将支持三个相互关联的任务 这项全面的可行性研究。首先，在研究的早期将举行跨学科峰会， 重点关注如何最好地降低风险并最大限度地使儿童和家庭受益于 一个未来的队列。这次以目标为导向的多领域领导人会议将为 了解有效招聘和管理人员的法律、道德和实际考虑因素 在纵向研究中保留其子女处于高危状态的家庭。二、可行性 将评估多面三管齐下的招聘战略：1)代表 通过大型全州临床研究联盟招募，2)对孕妇进行过度抽样 通过社区参与计划使用阿片类药物的女性，以及3)受访者驱动的 抽样以招募未接受治疗的使用阿片类药物的孕妇为目标。 第三，将从招募的参与者中收集精选的怀孕和出生评估 可行性研究，同时利用现有资源中关于幼儿的数据，以 第二阶段研究计划。FL-十年研究的第一阶段将提供有价值的规划和 可行性数据将用于国家努力建立一个庞大的、预期的队列。这个FL- 十年研究将为最佳抽样和保留策略提供重要信息 一个不同的家庭群体。孕妇物质使用方式的特征 一个大州的妇女将帮助制定全州范围的招聘战略。 评估在出生时获得成像和其他措施的能力，包括在物质中- 暴露在空气中的婴儿，将增加总体可行性评估。最后，创新的效用， 全州范围的链接数据源，以补充队列数据收集(并减少参与者 负担)将被确定。通过建立在大量强大资源的基础上，FL-十年研究将 能够确定可行性，并为大型预期队列的规划提供洞察力。

PROJECT SUMMARY 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.