The Healthy Brain and Child Development National Consortium Administrative Core

健康大脑和儿童发展国家联盟行政核心

• 批准号: 10770941
• 负责人: CHRISTINA CHAMBERS
• 金额: $ 162.08万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN DIEGO
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-30 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10770941
• 关键词: 10 year old; Address; Adopted; Behavioral; Birth; Brain; Child; Child Development; Code; Common Core; Communication; Complement; Data; Data Set; Development; Enrollment; Environment; Ethics; Infant; Infant Development; Leadership; Location; Measures; Modification; Monitor; Mothers; Nursery Schools; Parent-Child Relations; Performance; Physiological; Policies; Preparation; Process; Protocols documentation; Recommendation; Research; Research Design; Role; Sampling; School-Age Population; Site; Training; Validation; data quality; data reduction; improved; innovation; neuroimaging; operation; performance site; psychologic; recruit; tool

“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.

“这项研究是NIH的一部分，有助于结束长期（治愈）倡议，以加快美国阿片类药物公共卫生危机的科学解决方案。NIHHeal Heal Initiative Bolsters跨NIH的研究，以改善对阿片类药物滥用和成瘾的治疗。” 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 completed 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.为了解决这些广泛的对象，HCAC将监督研究设计，开发共同协议，监视招聘和保留，监视现场绩效，培训的提供，道德 政策，研究沟通管理以及考虑研究修改的过程的监督。这些活动将支持HBCD每年发布高质量研究数据集的目标。在启动HBCD的第一年研究准备工作中，HBCD指导委员会建议并通过了几项修改和澄清。这导致需要确保制定常见和严格的培训，管理和验证协议 并针对三项关键研究措施实施：婴儿发育4（BSID-4）的Bayley量表，Erica亲子互动测量和学龄前年龄精神病学评估（PAPA），所有这些评估将在HBCD研究的第一个五年循环中管理。通过这种补充，HCAC将负责集中培训和监测BSID-4现场给药的保真度，将监督对现场管理和Erica评估的集中编码的集中培训，并将监督PAPA测量的集中培训和管理。这些额外的HCAC努力将有助于限制 这些关键评估中的偏见与HCAC在协议培训和监视性能监测中的作用一致。