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

项目摘要 建立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、社会和情感功能由于以下因素的混淆而具有挑战性： 许多因素，包括其他不良的童年经历。我们提议的“佛罗里达- 儿童早期发展：逆境和药物暴露”研究，抽样 来自人口第三多的州，社会经济地位、种族/民族多样化， 农村性/城市性，将决定采用多方面办法征聘正常工作人员的可行性 以及高危孕妇和她们的孩子。如果成功， 随后使用该策略的佛罗里达队列将提供适当解释 混淆和识别与弹性相关的因素。三个相互关联的任务将支持 这是一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， 重点是如何以最佳方式减轻风险，最大限度地造福于被招募的儿童和家庭， 一个未来的群体这一面向目标的多领域领导人会议将提供一个全面的 了解有效招聘的法律的、道德和务实考虑因素， 在纵向研究中保留其子女处于高风险的家庭。二、可行性 一个多方面的三管齐下的招聘战略将评估：1）代表性 通过一个大型的全州范围的临床研究联盟招募，2）孕妇的过度抽样 通过社区参与计划使用阿片类药物的妇女，以及3）响应者驱动 抽样以招募未接受治疗的使用类阿片的孕妇为目标。 第三，将从招募的参与者中收集选择的妊娠和出生评估， 可行性研究，同时利用现有资源中的幼儿期数据， II期研究计划。FL-DECADE研究的第一阶段将提供有价值的规划， 可行性数据将用于国家努力建立一个大型的前瞻性队列。这个FL- DECADE研究将为最佳采样和保留策略提供重要信息 一个多元化的家庭。孕妇药物使用模式的特点 一个大州的妇女将协助制定全州的征聘战略。 评估出生时获得成像和其他测量的能力，包括物质- 暴露的婴儿，将添加到整体可行性评估。最后，创新的效用， 全州范围链接数据源，以补充队列数据收集（并减少参与者 负担）将被确定。通过利用大量强大的资源，FL-DECADE研究将 能够确定可行性并为大型前瞻性队列的规划提供见解。

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.