The Healthy Brain and Child Development National Consortium Administrative Core

“这项研究是NIH帮助结束长期成瘾（HEAL）计划的一部分，旨在加快国家阿片类药物公共卫生危机的科学解决方案。NIH HEAL倡议支持整个NIH的研究，以改善阿片类药物滥用和成瘾的治疗。 在六溴环十二烷管理核心（HCAC）的领导和管理下，健康大脑和儿童发育研究（HBCD）将部署一套协调、优化和创新的神经成像措施，辅之以一系列广泛的行为、生理和心理工具以及生物标本，以了解在美国各地研究中心登记的7，500名母亲和婴儿的神经发育轨迹。为了实现这些广泛的目标，HCAC将监督研究设计、共同方案的制定、招募和保留的监测、研究中心性能的监测、培训的提供、伦理 政策、研究沟通管理和研究修改过程监督。这些活动将支持六溴环十二烷每年发布高质量研究数据集的目标。在启动六溴环十二烷研究筹备工作的第一年，六溴环十二烷指导委员会建议并通过了对共同核心议定书的若干修改和澄清。这导致需要确保制定共同和严格的培训、管理和验证协议 并针对三项关键研究措施实施：贝利婴儿发育量表-4（BSID-4）、埃里卡亲子互动措施和学龄前儿童精神病评估，所有这些都将在六溴环十二烷研究的第一个五年周期内实施。根据本补充文件，HCAC将负责集中培训和监测BSID-4现场管理的准确性，将监督现场管理的集中培训和埃里卡评估的集中编码，并将监督PAPA措施的集中培训和管理。这些额外的HCAC努力将有助于限制 这些关键评估中的偏差，并与HCAC在方案培训和性能监测中的作用一致。

“This study is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative bolsters research across NIH to improve treatment for opioid misuse and addiction.” The HEALthy Brain and Child Development study (HBCD) under the leadership and management of the HBCD Administrative Core (HCAC) will deploy a harmonized, optimized, and innovative set of neuroimaging measures complemented by an extensive battery of behavioral, physiological, and psychological tools, and biospecimens to understand neurodevelopmental trajectories in a sample of 7,500 mothers and infants enrolled at sites across the US. To address these broad objectives, the HCAC will oversee study design, development of the common protocol, monitoring for recruitment and retention, monitoring for site performance, provision for training, ethical policies, management of study communications, and oversight of processes for considering study modifications. These activities will support the objective of HBCD to release a high-quality research dataset on an annual basis. In the first year of study preparations for the launch of HBCD, several modifications and clarifications to the common core protocol have been recommended and adopted by the HBCD Steering Committee. This has led to the need to ensure that common and rigorous training, administration, and validation protocols be developed and implemented for three key study measures: the Bayley Scales of Infant Development-4 (BSID-4), the ERICA parent-child interaction measure, and the Preschool Age Psychiatric Assessment (PAPA), all of which will be administered during the first five-year cycle for the HBCD study. With this Supplement, the HCAC will be responsible for centralized training and monitoring for fidelity of site administration of the BSID-4, will oversee centralized training for site administration and centralized coding of the ERICA assessments, and will oversee centralized training and administration of the PAPA measure. These additional HCAC efforts will help to limit bias in these key assessments and are consistent with the role of the HCAC in protocol training and monitoring for performance.