"1/6" Planning for HEALthy Early Development Study

项目摘要 健康早期发育研究的规划将有助于设计和建议 未来大规模，多地点研究的协议，前瞻性地检查人类大脑，认知， 从出生前到9-10岁的儿童的行为、社会和情感发展， 确定产妇产前和产后使用药物对儿童的短期和长期发展的影响， 孩子规划研究将把6个研究中心的研究者联系起来， 在设计研究所必需的领域的经验和专门知识。规划活动将 通过10个工作组的协调工作来完成，这些工作组将协同工作， 为今后的大规模研究确定和建议战略， 在以合乎道德的方式征聘和留住弱势群体方面的挑战，并制定和测试一个共同的 神经成像、婴儿和儿童评估、暴露评估、生物标本采集和 新技术的整合。到规划阶段结束时，6个联合体场地将生产 并测试了未来多中心研究的推荐方案，并将确定 在6个链接的研究中心中的每个研究中心执行研究方案。

PROJECT SUMMARY 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.