Healthy Brain and Child Development National Consortium Data Coordinating Center

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PROJECT SUMMARY 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 25 U01 sites (and five additional subcontract sites for 30 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 significant costs unbudgeted in the original HDCC submission and required for the successful establishment of these procedures. As detailed, these costs are directly related to multiple factors outside the purview of the original proposal, including: 1) a larger number of U01 and subcontract sites than originally budgeted based upon the final configuration of the HBCD Consortium; 2) greater costs for required computer hardware due to inflation- and supply chain-related cost increases since the original submission in March 2021; 3) greater data storage infrastructure requirements to accommodate collection of increased amounts of PII data based upon the final Consortium-defined study protocol; 4) varying levels of experience and expertise with key study elements (e.g., performing MRI scans in infants and toddlers without the use of sedating medications) across HBCD Consortium sites; and 5) varying extant resources for items determined by the Consortium to be critical for successful MRI data collection (e.g., noise attenuating headphones) across HBCD Consortium sites. Critically, the requested support is only for items required in Year 1 of the Consortium’s activities in order to satisfy study timelines and facilitate the successful, coordinated launch of the multimodal protocol across all U01 and subcontract sites, while concomitantly ensuring the fidelity of data collection and management procedures supported by the HDCC. 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.