HEAL Initiative: HEALthy Brain and Child Development (HBCD) Study Cooperative Agreement Award Series (U01 and U24 – Clinical Trial Not Allowed)

Program Description

NIMHD supports this series of Funding Opportunity Announcements (FOAs) that seek applications for the HEALthy Brain and Child Development (HBCD) Study using the cooperative agreement award mechanism. The projects linked with the HBCD Study will be part of the NIH’s Helping to End Addiction Long-term (HEAL) Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis.

The brain undergoes rapid development prenatally, through early childhood and into adolescence, supporting cognitive and emotional maturation. The relative paucity of research on normative brain development from birth through adolescence from a large, diverse cohort has limited our ability to fully understand how disruptions and experiences during early periods of growth impact individual developmental trajectories. To provide an index of normative child development and to address critical questions surrounding the long-term impact of high-risk environments, including substance exposure, the HBCD Study seeks to enroll a large, diverse cohort of pregnant women, who, along with their children, will be followed longitudinally.

A large prospective study is needed to understand how disruptions and experiences during early periods of growth, alone and in combination, interact with genetics and other biological influences (e.g., viral exposures) to affect a child’s developmental, and mental and physical health trajectories. Moreover, this study must include diverse populations to determine normal variability in development and factors that may disrupt it or build resilience. A deep, nuanced understanding of factors that affect a child’s health, brain and behavioral development is expected to emerge from this study, which is an essential first step toward designing policies and interventions that promote well-being and resilience in all children.

NIMHD is seeking applications to create and contribute to a consortium of research sites in service of the nationwide, multi-site, multi-modal, longitudinal cohort HBCD Study to prospectively examine brain and behavioral development from birth through childhood, including an emphasis on understanding the impact of in utero substance exposure on outcomes. Research sites will enroll pregnant women and collect data from them and their children using methodologies that include neuroimaging, neurophysiology, behavioral and cognitive assessments and collection of biospecimens.

There are four FOAs that run in parallel for this cooperative agreement:

HBCD Research Project Sites: Two FOAs seek applications for a set of research projects from a group of investigators (both within and across institutions) whose scientific and technical expertise will allow them to address the objectives and research questions described in the FOAs. A research project site can be a single institution if all functions (e.g., neuroimaging, biospecimen collection, non-imaging assessments) can be accomplished at that site; or a central hub institution with other institutions as spokes for the hub, such that all the required data collection can be accomplished by the contributing institutions. Applications that stand alone and are not linked should be submitted under the companion U01 FOA RFA-DA-21-021. Linked sets of collaborative U01 applications should be submitted under the companion U01 FOA RFA-DA-21-020, when two or more collaborating sites are essential to complete the proposed research.

HBCD Consortium Administrative Core: FOA RFA-DA-21-022 seeks applications for a single HBCD Consortium Administrative Core (HCAC) and is responsible for leadership and management of the HBCD consortium; including, budget, performance metrics, policies, communication, outreach and dissemination plans across the consortium.

HBCD Data Coordinating Center: FOA RFA-DA-21-023 seeks applications for a single HBCD Data Coordinating Center (HDCC) that will coordinate, standardize, and integrate all core data collection, processing, storage, and analytic activities of the consortium; facilitate data sharing and serve as a resource to the scientific community to enable broad use of the HBCD data. The HDCC will also provide real-time monitoring of consortium progress and performance.

The study objectives highlighted in each application should address the following overarching research questions that are central to the HBCD study:

What are typical neurodevelopmental trajectories and what is the normal range of variability in brain development from birth through childhood? How do biological and other environmental exposures affect these developmental trajectories?
How do genetic influences interact with environmental factors to influence neurodevelopment and cognitive, emotional, and social behavior?
How does early life exposure to opioids, other substances, and/or other adverse environmental circumstances affect developmental trajectories?
Are there key developmental windows during which the impact of adverse environmental exposures (e.g., stress, Coronavirus Disease 19) influence later neurodevelopmental outcomes?
Are there key developmental windows during which ameliorating influences (e.g., substance use disorder treatment; social/economic support) are protective against the potential neurodevelopmental insults of early adverse exposures?

NIH Guide Nos.: RFA-DA-21-020, RFA-DA-21-021, RFA-DA-21-022, RFA-DA-21-023

Page updated June 24, 2021