The landmark Healthy Brain and Child Development (HBCD) study will provide a representative reference data resource to the scientific community enabling unprecedented investigation of neurodevelopment and the impact of environmental, genetic, and biological factors on brain and behavioral health and developmental trajectories from infancy through childhood. Through this study, the HBCD Consortium will recruit and retain a sociodemographically diverse cohort of 7,500 pregnant women from 24 U01 sites (and three additional subcontract sites for 27 total data collection sites) across the U.S. and follow these families and their children through the first decade of life. Children will undergo rigorous data collection across modalities including neuroimaging, neurophysiology, behavioral and cognitive assessments, and collection of biospecimens via a study protocol developed by field-leading experts. The Healthy Brain and Child Development Data Coordinating Center (HDCC; U24 DA055330) will provide the leadership, management, and oversight of data collection, quality control, curation, processing, management, sharing, and analytics to facilitate and support the activities of the HBCD Consortium and ensure its success. This administrative supplement is necessary to accommodate costs unbudgeted in the original submission related to multiple factors including: 1) evolving study workflows and U01 site needs given the increasing complexity of study activities requires increased support for sites and central coordination with full-time Help Desk support; 2) time-sensitive data processing, management, standardization, harmonization, and quality control (QC) to ensure new opportunities around genetic data are properly managed and processed for integration into data releases; 3) new genetic and biosample opportunities require upgraded data security oversight and project management ensuring that all security protocols are maintained and data feeds from partners are robust; 4) changes in federal guidelines related to data sharing from FISMA-Low to FISMA-Moderate requires upgrades to general systems; 5) data usability and access facilitated through new data and software standards across all data elements; 6) accelerating processing of data downloads and access through dedicated computing; 7) audiovisual equipment to support anticipated transition from asleep to awake MRI scans at age 36 months; 8) expanding functionality requirements to support linkages between HBCD participant geocoding data and external databases, including integrated statistical analysis modules for these data in DEAP 2.0; and 9) opportunities to incorporate multimodal analyses encompassing EEG and MRI data. Critically, the requested support is for items identified by the Consortium and HDCC as critical for both improving support for data collection activities and ensuring organized, timely, compliant, and successful data releases. The result of this field leading investigation will be a state-of-the-art, longitudinal data set of unparalleled scale which provides deep understanding of the biological and environmental factors that affect a child’s health, brain, and behavioral development and shapes research, clinical care, and public policy for decades to come. 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.

PROJECT NARRATIVE The Healthy Brain and Child Development (HBCD) study will encompass data collection from a cohort of 7,500 parent-child dyads across 24 independent U01 sites and three additional subcontract sites over a range of modalities including harmonized neuroimaging, neurophysiology, behavioral and cognitive assessments, and the collection of biospecimens. This administrative supplement will enable the HBCD Data Coordinating Center to fully support successful and coordinated data collection and release activities across the Consortium through the accommodation of required and unplanned costs secondary to evolving study workflows and increasing site support needs, opportunities to incorporate new data types into HBCD, changes in federal guidelines related to data sharing, and modality-specific technical requirements for analysis.