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

佛罗里达州幼儿期发展：逆境和药物暴露（FL-DECADE）研究

• 批准号: 10019836
• 负责人: Matthew James Gurka
• 金额: $ 25.73万
• 依托单位: UNIVERSITY OF FLORIDA
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2021-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10019836
• 关键词: 10 year old; Achievement; Address; Advocate; Alcohol or Other Drugs use; Behavioral; Big Data; Birth; Brain; Caregivers; Child; Child Health; Clinical Research; Cognitive; Communities; Data; Data Collection; Data Sources; Development; Drug Exposure; Early Intervention; Education; Emotional; Enrollment; Ethical Issues; Ethicists; Ethics; Ethnic Origin; Family; Feasibility Studies; Florida; Focus Groups; Foundations; Future; Goals; Health; Health Personnel; Healthcare; Image; Infant; Infrastructure; Intervention; Laboratories; Learning; Legal; Link; Longitudinal cohort; Longitudinal prospective study; Measures; Mothers; Neonatal; Neurologic; Newborn Infant; Opioid; Participant; Pathway interactions; Patient Recruitments; Pattern; Pharmaceutical Preparations; Phase; Pilot Projects; Population; Pregnancy; Pregnant Women; Procedures; Prospective cohort; Race; Research; Research Personnel; Resources; Respondent; Risk; Sampling; Site; Socioeconomic Status; Structure; Testing; Universities; Woman; Work; adverse childhood events; base; cohort; data resource; early childhood; early life adversity; fetal drug exposure; fetal opioid exposure; high risk; in utero; innovation; insight; neonatal outcome; neonatal period; opioid epidemic; opioid treatment program; opioid use; participant retention; phase 2 study; programs; recruit; resilience; retention rate; rurality; social; symposium

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.

项目概要 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而具有挑战性 多种因素，包括其他不利的童年经历。 幼儿期的发展：逆境和药物暴露（FL-DECADE）”研究，抽样 来自人口第三多的州，社会经济地位、种族/族裔不同，并且 农村/城市，将决定采用多方面方法招聘正常人的可行性 如果成功的话，这个庞大而多样化的州的高危孕妇及其孩子将得到保护。 使用该策略的后续佛罗里达队列将提供适当解释的能力 混淆和识别与弹性相关的因素将支持三个相互关联的任务。 首先，在研究初期将举行一次跨学科峰会， 重点关注如何最好地减轻风险并最大限度地为招募的儿童和家庭带来利益 这次由多个领域的领导者组成的以目标为导向的会议将提供一个全面的会议。 了解有效招聘和招聘的法律、道德和务实考虑因素 让孩子处于高风险的家庭参与纵向研究第二，可行性。 将评估多方面、三管齐下的招聘策略：1）代表 通过大型全州临床研究联盟进行招募，2）对孕妇进行过度采样 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 抽样目标是招募使用阿片类药物但未接受治疗的孕妇。 第三，将从本次招募的参与者中收集选定的怀孕和分娩评估 可行性研究，同时利用现有资源中的幼儿数据，为 第二阶段研究计划。FL-DECADE 第一阶段研究将提供有价值的计划和指导。 可行性数据将用于国家建立大型前瞻性队列的工作。 十年研究将提供有关采样和保留策略的最佳重要信息 不同家庭群体的孕妇物质使用模式的特征。 整个大州的妇女将协助制定领土招募战略。 评估出生时获得影像和其他测量的能力，包括物质- 暴露婴儿，将添加到整体可行性评估最后，创新的效用。 全州范围内链接的数据源，以补充队列数据收集（并减少参与者 通过建立大量强大的资源，FL-DECADE 研究将被确定。 能够确定可行性并为大型前瞻性队列的规划提供见解。