Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
1U24DA055325-01
The Healthy Brain and Child Development National Consortium Administrative Core Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF CALIFORNIA, SAN DIEGO CHAMBERS, CHRISTINA (contact); NELSON, CHARLES ALEXANDER La Jolla, CA 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Consortium Administrative Core (U24 - Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-022
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Administrative Core (HCAC) will coordinate efforts across all sites in the HBCD-NC consortium to ensure that the consortium meets its primary objective to establish a normative model of developmental trajectories over the first 10 years of life. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HCAC will oversee study design and monitor the progress of each site’s ability to carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. This administrative core is located at the University of California, San Diego.
5U24DA055325-02
The HEALthy Brain and Child Development National Consortium Administrative Core Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF CALIFORNIA, SAN DIEGO CHAMBERS, CHRISTINA (contact); NELSON, CHARLES ALEXANDER La Jolla, CA 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.
1R34DA050286-01
The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA FATHER FLANAGAN'S BOYS' HOME BLAIR, JAMES Boys Town, NE 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data.
1R34DA050255-01
Planning Phase for the Healthy Brain and Child Development Study (HEALthy BCD) in Los Angeles County Area Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CEDARS-SINAI MEDICAL CENTER GAO, WEI (contact); GREGORY, KIMBERLY D; JOHNSON, SCOTT P Los Angeles, CA 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Prevalence rates of opioids misuse in Los Angeles County (LA) are particularly high among individuals of childbearing age and in already-vulnerable populations including African American females. These data highlight a pressing need for a systematic study of the effects of prenatal drug exposures (PDE) in the unique sociodemographic LA County area. In this project, researchers aim to establish the feasibility for the large-scale Phase II HEALthy BCD study in the Los Angeles area with three specific aims: (1) build a broad interdisciplinary team of investigators capable of a multi-faceted study of brain and behavioral development in both typically developing and at-risk infants/children; (2) establish a set of highly executable recruitment and retention strategies for both drug-free and drug-exposed infants/children; and (3)establish comprehensive study protocols that will help address the three key research objectives of the Phase II study.
1R34DA050292-01
HEALthy ORCHARD: Developing plans for a Baltimore site of the HEALthy BCD study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA JOHNS HOPKINS UNIVERSITY FALLIN, M DANIELE Baltimore, MD 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Researchers will expand a recently initiated pregnancy cohort at Johns Hopkins University (JHU) called ORCHARD (ORigins of Child Health And Resilience in Development) to create a Baltimore HEALthy BCD site, named HEALthy ORCHARD. The research team will convene investigators at JHU and the Kennedy Krieger Institute (KKI), and community partners across nine work groups to: (1) develop protocols for recruitment and retention of pregnant mothers and children with enriched sampling of pregnant women who are using substances; (2) establish community, medical, and government partnerships necessary to implement recruitment, retention, data collection and community benefits; (3) characterize the critical ethical and legal challenges raised during study design, in pilot studies, and by prospective participants, and propose solutions where possible and additional research where necessary; (4) develop protocols for longitudinal data collection across pregnancy and childhood; and (5) contribute to multi-site protocol development and nationally relevant principles regarding ethical and legal issues.
1U01DA055322-01
HEALthy Brain and Child Development Study at UAB and UA Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF ALABAMA AT BIRMINGHAM PERALTA-CARCELEN, ADA MYRIAM (contact); NEWMAN, SHARLENE D; NEWSOM, CASSANDRA R; YERBY, LEA GEORGETTE Birmingham, AL 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-021
Summary:

Researchers at the University of Alabama at Birmingham and the University of Alabama will enroll pregnant women during their second trimester and follow their infants through a comprehensive longitudinal study. This program will follow 300 mother-infant pairs to understand how early life exposure to drugs and other environmental factors affects developmental trajectories. In addition, this program will determine how genetic and biological factors interact with environmental factors to influence neurodevelopment. This study will take place at the University of Alabama at Birmingham, recruiting participants from mainly rural populations with low access to obstetric/gynecological (OB/GYN) care and high rates of substance use.
3U24DA055330-03S1  
HEALthy Brain and Child Development National Consortium Data Coordinating Center Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA WASHINGTON UNIVERSITY SMYSER, CHRISTOPHER DANIEL (contact); FAIR, DAMIEN A Saint Louis, MO 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.
1U24DA055330-01
Healthy Brain and Child Development National Consortium Data Coordinating Center Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA WASHINGTON UNIVERSITY SMYSER, CHRISTOPHER DANIEL (contact); DALE, ANDERS M; FAIR, DAMIEN A St Louis, MO 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Data Coordinating Center (U24)
NOFO Number: RFA-DA-21-023
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) Data Coordinating Center (HDCC) will provide data management and oversight to all HBCD-NC sites to ensure the consortium’s primary objective of establishing a normative template of developmental trajectories over the first 10 years of life is met. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The HDCC will coordinate data collection, data quality, data harmonization, data sharing, and data analysis efforts that are central to the consortium’s ability to implement a common research protocol. The HDCC will assemble all data across the consortium sites and distribute a comprehensive and well curated research dataset to the scientific community at large. The HDCC is tightly integrated with the HEALthy Brain and Child Development Administrative Core (HCAC) and includes a multi-institution investigative team at the University of Minnesota, University of California, San Diego, and Washington University at St Louis.
3U01DA055354-03S1
HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF VERMONT & ST AGRIC COLLEGE POTTER, ALEXANDRA S (contact); GARAVAN, HUGH P Burlington, VT 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies. 
3U01DA055359-03S1
HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M Albuquerque, NM 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies
3U01DA055365-03S1
HBCD Study Biospecimens Administrative Supplement: Resource Generation for Delivery Specimens Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CHILDREN'S HOSP OF PHILADELPHIA HUANG, HAO (contact); DEMAURO, SARA BONAMO Philadelphia, PA 2023
NOFO Title: Notice of Special Interest (NOSI): HEAL Initiative: Biospecimen Collection in Pregnancy
NOFO Number: NOT-DA-23-005
Summary:

Opioid use during pregnancy is associated with adverse outcomes for pregnant individuals and offspring. The mechanisms through which these outcomes arise and the consequences of prenatal opioid exposure on child health and development remain largely unexplored. The HEALthy Brain and Child Development (HBCD) Study is a nationwide longitudinal prospective study of early child development that will assess a broad spectrum of biological, behavioral, social, and health factors among 7,500 pregnant women and their children from pregnancy to mid-childhood. This supplement will expand the biospecimen collection of the HBCD protocol at the University of North Carolina at Chapel Hill to include delivery specimens (placenta, cord tissue, and cord blood). This will provide an unprecedented resource-generating opportunity for the larger scientific community to comprehensively evaluate mechanisms that mediate the connection between substance use during pregnancy and adverse neonatal, infant, and/or maternal health outcomes and inform innovative preventive strategies.
1R34DA050299-01
Florida Development in Early Childhood: Adversity and Drug Exposure (FL-DECADE) Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF FLORIDA GURKA, MATTHEW JAMES Gainesville, FL 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

This study will determine the feasibility of a multifaceted approach to recruitment of normal and high-risk pregnant women and their children. Three inter-related tasks will support this comprehensive feasibility study. First, an interdisciplinary summit will occur early in the study focused on how best to mitigate risks and maximize benefits to children and families recruited in a future cohort. Second, the feasibility of a multi-faceted recruitment strategy will be assessed. Third, select pregnancy and birth assessments will be collected from recruited participants in this feasibility study while leveraging data across early childhood from existing resources, to inform Phase II study planning. This Phase I of the FL-DECADE study will provide valuable planning and feasibility data to be used for the national efforts to build a large, prospective cohort.
1R34DA050254-01
Biological and Environmental Contributions to Healthy Baby Development in Diverse Population Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CHILDREN'S HOSPITAL OF LOS ANGELES LEVITT, PAT Los Angeles, CA 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

This project will support consortium hypothesis generation in Phase II in order to disentangle how complex environmental factors impact brain development and function — from fetal period through the first decade — to shape cognitive, social, and emotional development. The project will develop the strategies to recruit and retain a racially and ethnically diverse sample of pregnant women (and their fetuses), who are oversampled for adverse environmental risk factors and exposure to substances of abuse; develop the strategies for managing potential legal and ethical challenges to ensure that the mother–child dyads have access to legal, social, and psychological support services as needed; and determine the optimal study protocol for the planned, phase II study — balancing the need for high quality, longitudinal data collection with the need to minimize burden on the mother–child dyads.
1R34DA050297-01
A feasibility study of novel technologies to minimize motion-induced biases in functional and structural MRI of young, opioid-affected cohorts Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF PENNSYLVANIA TISDALL, MATTHEW DYLAN (contact); MACKEY, ALLYSON PATRICIA Philadelphia, PA 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-036
Summary:

Structural and functional neuroimaging measures are prone to errors induced by subject motion. Many comorbid features of opioid exposure are likely to increase children’s in-scanner motion. In total, this raises substantial concern that existing neuroimaging methods are not sufficiently motion-robust to be used in studies of children ages 3–5. Researchers will address these concerns with a feasibility study, comparing the existing methods developed for the Adolescent Brain Cognitive Development (ABCD) study with novel methods we will develop and optimize for young children. They will evaluate research methods in a sample of 100 children and test whether novel technologies improve the quality of the raw imaging data and reduce motion biases in the derived measures. Researchers will determine predictors of successful imaging to inform sampling strategies in future studies. The primary outcomes will be novel, validated structural and functional neuroimaging imaging methods for young children and feasibility data to inform the design of future studies addressing developmental questions, particularly those related to opioid exposure.
1U01DA055355-01
9/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA NORTHWESTERN UNIVERSITY AT CHICAGO WAKSCHLAG, LAUREN S (contact); NORTON, ELIZABETH SPENCER Chicago, IL 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative template of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The Northwestern University study site is in Chicago where rates of prenatal substance use are rising and consistent with the national trend. This site will recruit a diverse urban sample of mother-infant pairs reflecting the population of Chicago.
1U01DA055338-01
8/24 The Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA NEW YORK UNIVERSITY SCHOOL OF MEDICINE THOMASON, MORIAH E (contact); BERRY, OBIANUJU ; SHUFFREY, LAUREN CHRISTINE New York, NY 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first decade of life. This study will take place at New York University School of Medicine, allowing researchers to recruit participants from two of the largest private and public health systems in the country and include racial and ethnic minorities of varying economic levels.
1U01DA055350-01
7/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA JOHNS HOPKINS UNIVERSITY VOLK, HEATHER E (contact); PEKAR, JAMES J; SATIN, ANDREW J Baltimore, MD 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. This study will be conducted at Johns Hopkins University in Baltimore, Maryland, and researchers will recruit diverse participants from a range of backgrounds.
1R34DA050237-01
6/6 Planning for the HEALthy Early Development Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M; STEPHEN, JULIA MARIE Albuquerque, NM 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

The Planning for the HEALthy Early Development Study will contribute to the design and recommended protocol for a future large-scale, multi-site research study to prospectively examine human brain, cognitive, behavioral, social, and emotional development of children beginning prenatally through ages 9–10 and to determine the impact of maternal pre- and postnatal substance use on short- and long-term development of children. The planning study will link investigators across 6 research sites who have complementary experience and expertise in the areas that are essential to designing the study. Planning activities will be accomplished using a coordinated set of 10 working groups. By the end of the planning phase, the 6 consortium sites will have produced and tested a recommended protocol for the future multi-site study and will have established feasibility of carrying out the study protocol at each of the 6 linked sites.
1U01DA055347-01
6/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Vanderbilt Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA VANDERBILT UNIVERSITY CUTTING, LAURIE E (contact); OSMUNDSON, SARAH SCHEIDERICH Vanderbilt, TN 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The objective of the HBCD PRELUDE (Prenatal Experiences and Longitudinal Development) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The Vanderbilt University site will enroll a diverse sample of mother-infant dyads reflective of the racial, ethnic, and economic composition of the demographics of Tennessee, including rural areas dramatically affected by the opioid crisis.
1U01DA055344-01
5/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIV OF NORTH CAROLINA CHAPEL HILL LIN, WEILI (contact); GREWEN, KAREN M Chapel Hill, NC 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The objective of the HBCD PRELUDE (Prenatal Experiences and Longitudinal Development) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The study site at the University of North Carolina, Chapel Hill will work with Wake Forest University to help recruit pregnant women with substance use disorders and enroll mother-infant dyads. This collaboration serves to expand participant diversity and extend recruitment to cover a larger region of North Carolina, a state hit hard by the opioid crisis.
1R34DA050256-01
5/5 Establishing Innovative Approaches for the HEALthy Brain and Child Development Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF ILLINOIS AT URBANA-CHAMPAIGN MCELWAIN, NANCY L CHAMPAIGN, IL 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

A more than 5-fold increase in the incidence of neonatal abstinence syndrome has been reported since 2000. Preliminary studies show that prenatal opioid exposure is associated with increased risk of impaired neurodevelopment. Five institutions (Duke University, Arkansas Children’s Research Institute, Cincinnati Children’s Hospital, University of Illinois at Urbana–Champaign, and University of North Carolina at Chapel Hill) have formed a consortium to develop strategies for the Phase II HEALthy Brain and Child Development Study. Research teams will develop instruments and strategies (recruitment/retention protocols, assessment batteries, and novel tools); conduct pilot studies (fetal and postnatal imaging, advanced imaging harmonization and quality control, assessment administration, biosampling) to evaluate instruments; and analyze available data, including imaging, behavioral, cognitive, and maternal data from studies on early brain development, to guide the Phase II study design. Upon completion, the consortium aims to conduct the Phase II study.
1U01DA055353-01
5/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA BOSTON CHILDREN'S HOSPITAL GRANT, PATRICIA ELLEN (contact); BOSQUET ENLOW, MICHELLE A Boston, MA 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The HEALthy Brain and Child Development National Consortium (HBCD-NC) will establish a normative model of developmental trajectories over the first 10 years of life. All sites in the HBCD-NC will carry out a common research protocol and will assemble and distribute a comprehensive research dataset to the scientific community. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. Most  participants will be recruited in the second trimester of pregnancy, with a smaller subset recruited at birth, and followed for the first 10 years of life. The Boston Children’s Hospital study site is in Massachusetts, which has the fifth highest rate of opioid use in the U.S., and twice the U.S. average incidence of opioid use disorder in delivering mothers.
1R34DA050341-01
4/6 Planning for the HEALthy Early Development Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF CALIFORNIA, SAN DIEGO CHAMBERS, CHRISTINA La Jolla, CA 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

The Planning for the HEALthy Early Development Study will contribute to the design and recommended protocol for a future large-scale, multi-site research study to prospectively examine human brain, cognitive, behavioral, social, and emotional development of children beginning prenatally through ages 9–10 and to determine the impact of maternal pre- and postnatal substance use on short- and long-term development of children. The planning study will link investigators across 6 research sites who have complementary experience and expertise in the areas that are essential to designing the study. Planning activities will be accomplished using a coordinated set of 10 working groups. By the end of the planning phase, the 6 consortium sites will have produced and tested a recommended protocol for the future multi-site study and will have established feasibility of carrying out the study protocol at each of the 6 linked sites.
1U01DA055342-01
4/6 HBCD Prenatal Experiences and Longitudinal Development (PRELUDE) Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CINCINNATI CHILDRENS HOSP MED CTR MERHAR, STEPHANIE L (contact); VANNEST, JENNIFER J Cincinnati, OH 2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed)
NOFO Number: RFA-DA-21-020
Summary:

The objective of the HEALthy Brain and Child Development (HBCD) Prenatal Experiences and Longitudinal Development (PRELUDE) multi-site consortium is to characterize typical brain development from birth through childhood. All sites in this consortium will measure the influence of key biological and environmental factors on child social, cognitive, and emotional development. Researchers will assess how prenatal exposure to opioids and other substances, as well as other adverse environmental factors, affect brain development and other child health outcomes. The Cincinnati Children’s Hospital study site is in a region hit hard by the opioid crisis and has a large catchment area that includes many rural counties in Ohio, Kentucky, Indiana, and West Virginia.
1R34DA050289-01
4/5 The Cumulative Risk of Substance Exposure and Early Life Adversity on Child Health Development and Outcomes Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA BOSTON CHILDREN'S HOSPITAL NELSON, CHARLES ALEXANDER Boston, MA 2019
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (HEALthy BCD) (Collaborative R34 Clinical Trial Not Allowed)
NOFO Number: RFA-DA-19-029
Summary:

Despite increased efforts to understand the neurodevelopmental sequelae of in utero opioid and other substance exposure on long-term behavioral, cognitive, and societal outcomes, important questions remain, specifically, 1) How is brain growth disrupted by fetal substance and related pre- and post-natal exposures? and 2) How are these disrupted growth patterns causally related to later cognitive and behavioral outcomes? This project seeks to formulate an approach to addressing these key questions and decipher the individual and cumulative effect of these intertwined pre- and post-natal exposures on child neurodevelopment. First, researchers will address the legal, ethical, and mother-child care and support concerns implicit in this study. Next, they will integrate across our areas of neuroimaging expertise to develop, implement, and harmonize a multi-modal MRI and EEG protocol to assess maturing brain structure, function, and connectivity. Finally, researchers will develop and test advanced statistical approaches to model and analyze this multidimensional and longitudinal data.