4/6 Planning for the HEALthy Early Development Study

4/6 健康早期发育研究规划

• 批准号: 9900304
• 负责人: CHRISTINA CHAMBERS
• 金额: $ 26.58万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 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 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9900304
• 关键词: Address; Adolescence; Adolescent; Age; Alcohol or Other Drugs use; Alcohols; Area; Attention; Behavioral; Biological Markers; Brain; Cannabis; Child; Child Development; Childhood; Cognitive; Cohort Studies; Collaborations; Collection; Complex; Data; Development; Emotional; Environment; Environmental Exposure; Epidemic; Ethics; Exposure to; Funding; Future; Goals; Growth; Growth and Development function; Human; Human Development; Individual; Infant; Institution; Leadership; Legal; Life; Link; Longitudinal cohort study; Measurement; Measures; Mental disorders; Methods; National Institute of Drug Abuse; Opioid; Outcome; Performance; Phase; Pregnancy; Prospective cohort study; Protocols documentation; Recommendation; Research; Research Design; Research Personnel; Risk; Sample Size; Sampling; Site; Structure; Techniques; Testing; Time; Tobacco; United States National Institutes of Health; Vulnerable Populations; Woman; Work; cognitive development; critical period; design; early childhood; evidence base; experience; fetal opioid exposure; infancy; innovation; innovative technologies; meetings; middle childhood; neurobehavioral; neuroimaging; new technology; phase 2 study; postnatal; prenatal; prospective; recruit; research study; retention rate; social; synergism; tool; treatment strategy; uptake; working group

ABSTRACT The Planning for the HEALthy Early Development Study will contribute to the design and recommended protocol for a future large-scale, multi-site research study to prospectively examine human brain, cognitive, behavioral, social and emotional development of children beginning prenatally through ages 9-10, and to determine the impact of maternal pre- and postnatal substance use on short- and long-term development of children. The Planning Study will link investigators across 6 research sites who have complementary experience and expertise in the areas that are essential to designing the study. Planning activities will be accomplished using a coordinated set of 10 Working Groups who will work collaboratively to design a sampling and recruitment strategy for a future large-scale study, to identify and recommend strategies for addressing the challenges to ethical recruitment and retention of vulnerable populations, and to develop and test a common protocol for neuroimaging, infant and child assessments, exposure assessment, biospecimen collection, and integration of novel technologies. By the end of the Planning Phase, the 6 Consortium sites will have produced and tested a recommended protocol for the future multi-site study, and will have established feasibility of carrying out the study protocol at each of the 6 linked sites.

摘要 健康早期发展研究的规划将有助于设计和 未来大规模、多中心研究的推荐方案， 人类的大脑，认知，行为，社会和儿童的情感发展开始 并确定产妇产前和产后 药物使用对儿童短期和长期发展的影响。规划研究将联系 6个研究中心的研究者，他们在以下方面具有互补的经验和专业知识： 这些领域对于设计研究至关重要。规划活动将使用 由10个工作组组成的协调小组，他们将协同工作， 招募战略，为未来的大规模研究，以确定和建议的战略， 解决在以合乎道德的方式征聘和留住弱势群体方面的挑战， 制定和测试神经成像、婴儿和儿童评估、暴露 评估、生物标本收集和新技术的整合。结束时 规划阶段，6个联合体研究中心将制定并测试推荐方案 用于未来的多中心研究，并将确定实施研究方案的可行性 在6个链接站点中的每一个。