4/6 Planning for the HEALthy Early Development Study

摘要 健康早期发展规划研究将有助于设计和 推荐的未来大规模多地点研究研究的推荐方案，以进行前瞻性检查 儿童大脑、认知、行为、社交和情绪发育开始 从产前到9-10岁，并确定母亲产前和产后的影响 物质使用对儿童短期和长期发展的影响。规划研究将链接 6个研究站点的调查人员，他们在以下领域具有互补的经验和专业知识 对设计这项研究至关重要的领域。计划活动将使用 由10个工作组组成的协调小组，他们将协同工作，设计一份抽样和 招聘战略，为未来的大规模研究，以确定和建议战略 应对在道德上招募和留住弱势人口方面的挑战，并 制定和测试神经成像、婴幼儿评估、暴露的通用方案 评估、生物样品收集和新技术的整合。到年底的时候 规划阶段，6个联合体站点将产生并测试推荐的协议 为今后的多点研究，并将建立实施研究议定书的可行性 在6个链接站点中的每一个。

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.