4/6 Planning for the HEALthy Early Development Study

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。规划研究将把 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。

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.