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.

项目摘要 确定产前阿片类药物暴露如何影响大脑发育，以及短期和长期的 术语认知，行为，社会和情感功能，由于混淆而具有挑战性 无数因素，包括其他不利的童年经历。我们提议的“佛罗里达 - 幼儿期的发展：逆境和药物暴露（FL-DECADE）”研究，取样 从人口最多的州，社会经济地位，种族/民族的潜水 粗糙度/城市性，将确定多方面招募正常方法的可行性 以及这个大型，多元化的州，高风险的孕妇及其子女。如果成功， 随后使用此策略的佛罗里达人群将提供适当说明的能力 混淆并确定与弹性相关的因素。三个相互关联的任务将支持 这项全面的可行性研究。首先，研究早期将发生跨学科峰会， 专注于如何最好地降低风险并最大程度地利用招募儿童和家庭的利益 未来的队列。这次以目标为导向的领导者会议在多个领域将提供一个彻底的 理解有效招聘和的法律，道德和务实考虑因素 将家庭留在纵向研究中，其孩子处于高风险。第二，可行性 将评估多面三管齐下的招聘策略：1）代表性 通过大型全州临床研究联盟招募，2）怀孕的过采样 通过社区参与计划使用阿片类药物的妇女，以及3）响应驱动 采样以针对使用未接受治疗的阿片类药物的孕妇的招募。 第三，将从招聘参与者中收集精选的怀孕和出生评估 可行性研究，同时从现有资源中利用幼儿期的数据，以告知 第二阶段研究计划。十年研究的第一阶段将提供有价值的计划和 可行性数据用于建立大型，潜在的队列的国家努力。这个fl- 十年的研究将为最佳采样和保留策略提供重要信息 一个潜水家庭的家庭。怀孕的物质使用模式的表征 大型州的妇女将有助于制定全州招聘策略。 评估在出生时获得成像和其他措施的能力，包括物质 - 暴露的婴儿将增加总体可行性评估。最后，创新的实用性， 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 将确定Burnen）。通过建立大量强大的资源，FLEDECADE研究将 能够确定可行性并为规划一个大型，潜在的队列提供洞察力。