HEALthy Brain and Child Development Study (HBCD)

Overview

The Research Need

The first few years of life are a period of exponential growth and brain development. The long-term effects of perinatal exposure to opioids on infant and child development are unknown.

To address this knowledge gap, NIH is supporting research to better understand brain development, beginning in the perinatal period, and extending through early childhood, including variability in development and how it contributes to cognitive, behavioral, social, and emotional function. Knowledge of normative brain trajectories is critical to understanding how they may be affected by exposure to opioids and other substances (e.g., alcohol, tobacco, cannabis), stressors, trauma, and other significant environmental influences, including those that promote resilience.

About the Program

The HEALthy Brain and Child Development (HBCD) Study will recruit a large cohort of pregnant women from regions of the country significantly affected by the opioid crisis and follow them and their children through early childhood. The study will collect information beginning at birth and continuing through early childhood, including structural and functional brain imaging; anthropometrics; medical history; family history; biospecimens; and social, emotional, and cognitive development.

Knowledge gained from this research will be used to better understand and ultimately prevent or attenuate the harms of prenatal and postnatal exposure to drugs or other adverse environmental conditions, including risk for early substance use, mental disorders, and other behavioral and developmental problems. It will also identify resilience factors that may mitigate some of these adverse outcomes.

Program Details

Through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL InitiativeSM  in collaboration with the National Institute on Drug Abuse and several NIH Institutes and Centers, NIH has funded 29 awards totaling $15.8 million in Phase I of the HEALthy Brain and Child Development (HBCD) Study, and 27 awards totaling $37.1 million for Phase II of the HBCD Study.

Phase I of the HBCD Study concluded an 18-month planning period during which awardees considered the experimental design and feasibility of approaches. Awardees conducted multisite pilot and feasibility studies addressing five key areas that are crucial for the Phase II study:

  • Recruitment and retention strategies
  • Ethical and legal challenges
  • Imaging technologies
  • Other assessment methodologies
  • Biospecimen collection and analysis

This planning phase was critical for ensuring a robust study design for the Phase II HBCD Study, which will launch in October 2021. In Phase II, a fully integrated, collaborative infrastructure will support the collection of data that will enable researchers to analyze brain and behavioral development in substance-exposed and non-drug-exposed infants and children across a variety of regions and from diverse demographic backgrounds.

Research Examples

Examples of HBCD Study activities include:

  • Multi-modal assessments of brain, cognitive and emotional development from birth through childhood to assess typical neurodevelopmental trajectories and determine how substance exposure and other environmental factors affect these developmental trajectories.
  • Creation of a large, diverse well-characterized cohort of caregivers, infants, and children whose anonymized data will be made available for analysis to the greater research community for years to come.
  • Evaluation of key developmental windows during which the impact of adverse environmental exposures (e.g., drugs, stress, COVID-19) or ameliorating factors (e.g., substance use disorder treatment; social/economic support) influence neurodevelopmental outcomes.
  • Identification of actionable items as results emerge pertinent to prevention, public policies, and innovative products.
  • Development, optimization, and validation of technologies for neuroimaging and neurophysiological assessments of infants, with standardized analysis pipelines.
  • Collaborative model with creation of community liaison boards comprising medical providers, patient advocates, ethicists, and representatives from state agencies to inform the study design and provide ongoing feedback throughout its lifetime.
  • Determination of the feasibility of mobile or wearable technology to track parent-child interactions and child physiology.

Phase II

  • Arkansas Children’s Hospital Research Institute – Arkansas
  • Boston Children’s Hospital – Massachusetts
  • Cedars-Sinai Medical Center – California
  • Children’s Hospital of Los Angeles – California
  • Children’s Hospital of Philadelphia – Pennsylvania
  • Cincinnati Children’s Hospital Medical Center – Ohio
  • Emory University – Georgia
  • Johns Hopkins University – Maryland
  • New York University School of Medicine – New York
  • Northwestern University – Illinois
  • Oklahoma State University Center for Health Sciences – Oklahoma
  • Oregon Health and Science University – Oregon
  • Pennsylvania State University – Pennsylvania
  • Rhode Island Hospital – Rhode Island
  • University of Alabama at Birmingham –  Alabama
  • University of California, San Diego –  California
  • University of Florida –  Florida
  • University of Maryland –  Maryland
  • University of Minnesota –  Minnesota
  • University of New Mexico Health Sciences Center –  New Mexico
  • University of North Carolina Chapel Hill –  North Carolina
  • University of Vermont –  Vermont
  • University of Wisconsin-Madison –  Wisconsin
  • Vanderbilt University –  Tennessee
  • Washington University –  Missouri

Phase I

  • Arkansas Children’s Hospital Research Institute – Arkansas
  • Avera McKennan Hospital & University Health Center – South Dakota
  • Boston Children’s Hospital – Massachusetts
  • Case Western Reserve University – Ohio
  • Cedars-Sinai Medical Center – California
  • Children’s Hospital of Los Angeles – California
  • Children’s Hospital of Philadelphia – Pennsylvania
  • Children’s Research Institute – Washington D.C.
  • Cincinnati Children’s Hospital Medical Center – Ohio
  • Duke University – North Carolina
  • Emory University – Georgia
  • Father Flanagan’s Boys’ Home – Nebraska
  • Johns Hopkins University – Maryland
  • Mt. Sinai School of Medicine – New York
  • New York University School of Medicine – New York
  • Northwestern University – Illinois
  • Oklahoma State University Center for Health Sciences – Oklahoma
  • Oregon Health & Science University – Oregon
  • Pennsylvania State University – Pennsylvania
  • Rhode Island Hospital – Rhode Island
  • University of Alabama at Birmingham – Alabama
  • University of California, San Diego – California
  • University of Florida – Florida
  • University of Illinois at Urbana-Champaign – Illinois
  • University of Maryland – Maryland
  • University of Minnesota – Minnesota
  • University of New Mexico Health Sciences Center – New Mexico
  • University of North Carolina, Chapel Hill – North Carolina
  • University of Pennsylvania – Pennsylvania
  • University of Pittsburgh – Pennsylvania
  • University of Vermont – Vermont
  • University of Wisconsin-Madison – Wisconsin
  • Vanderbilt University – Tennessee
  • Washington University – Missouri
  • Women & Infants Hospital in Rhode Island – Rhode Island

Funded Projects

2021
1/24 Healthy Brain and Child Development National Consortium
Sep 20, 2021
2021
20/24 The Healthy Brain and Child Development National Consortium
Sep 20, 2021
2021
HEALthy Brain and Child Development Study at UAB and UA
Sep 20, 2021
2021
9/24 Healthy Brain and Child Development National Consortium
Sep 20, 2021
2020
1/2 Optimizing access, engagement and assessment to elucidate prenatal influences on neurodevelopment: The Brains Begin Before Birth (B4) Midwest Consortium
Mar 19, 2020

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