Funded Projects

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Project # Project Title Research Focus Area Research Program Administering IC Institution(s) Investigator(s) Location(s) Year Awarded
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
1U01DA055359-01
18/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR BAKHIREVA, LUDMILA NICOLE (contact); LEEMAN, LAWRENCE M Albuquerque, NM 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 and well curated research dataset to the scientific community at large. 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 University of New Mexico Health Science Center study site is in a largely rural/mixed state with one of the highest rates of overdose in the nation. This site will enroll diverse mother-infant pairs and partners or caregivers, including Hispanic/Latinx and American Indian individuals.
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.
1U01DA055360-01
4/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA EMORY UNIVERSITY KABLE, JULIE A (contact); COLES, CLAIRE D Atlanta, GA 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 Emory University School of Medicine in Atlanta, Georgia, allowing access to a diverse population with a high representation of Black/African American women.
1R34DA050340-01
2/6 Planning for the HEALthy Early Development Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA EMORY UNIVERSITY COLES, CLAIRE D (contact); KABLE, JULIE A Atlanta, GA 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.
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.
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.
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.
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.
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.
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.
1U01DA055354-01
20/24 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 UNIVERSITY OF VERMONT & ST AGRIC COLLEGE POTTER, ALEXANDRA S (contact); GARAVAN, HUGH P Burlington, VT 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 and well curated research dataset to the scientific community at large. The HBCD-NC will collect neural, behavioral, physiological, and psychological measures, as well as biospecimens, to characterize neurodevelopmental trajectories. The majority of 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. The University of Vermont study site will recruit mother-infant dyads from a rural area in Vermont, a state in which nearly one-third of neonatal hospitalizations are for neonatal abstinence syndrome (NAS).
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. 
1R34DA050283-01
3/4 Investigation of opioid exposure and neurodevelopment (iOPEN) 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; HEIL, SARAH H Burlington, VT 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:

Rates of neonatal abstinence syndrome have reached a staggering 6.5 per 1,000 births nationwide, creating an urgent need to identify how in-utero exposure to opioids and associated risk factors influence the developing brain. A multidisciplinary team will address these challenges in Oregon, a state particularly hard hit by the opioid epidemic. Through linking sites, the impact of the Phase I project is enhanced and will provide critical information to support a national-level effort for Phase II of the HEALthy Brain and Child Development Study. Aim 1 will develop, implement, and evaluate innovative recruitment and retention strategies for high-risk populations. Aim 2 will address anticipated challenges of the planned Phase II study by implementing and evaluating a multi-site, standardized research protocol including multimodal MRI of placenta, fetus, neonate, and 24-month-old brain; biospecimen collection; and assessment of substance use and other key domains. Aim 3 will evaluate data acquisition, processing, and statistical considerations to maximize data quality, usability, and integration across sites.
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.
1R34DA050262-01
1/5 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 UNIV OF NORTH CAROLINA CHAPEL HILL LIN, WEILI (contact); GILMORE, JOHN HORACE; GREWEN, KAREN M; JONES, HENDREE E Chapel Hill, NC 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.
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.
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.
1R34DA050268-01
4/5 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 CINCINNATI CHILDRENS HOSP MED CTR MERHAR, STEPHANIE L (contact); VANNEST, JENNIFER J Cincinnati, OH 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.
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.
1R34DA050342-01
1/6 Planning for the HEALthy Early Development Study Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA CASE WESTERN RESERVE UNIVERSITY SINGER, LYNN T Cleveland, OH 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.
1U01DA055316-01
16/24 Healthy Brain and Child Development National Consortium Enhanced Outcomes for Infants and Children Exposed to Opioids HEALthy Brain and Child Development Study (HBCD) NIDA UNIV OF MARYLAND, COLLEGE PARK FOX, NATHAN A (contact); HARDEN, BRENDA J; RIGGINS, TRACY L College Park, 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. The University of Maryland College Park study site is midway between Washington, DC, and Baltimore, Maryland, and will recruit a diverse sample of mother-infant pairs from across the region.
1R34DA050285-01
3/5 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 UNIV OF MARYLAND, COLLEGE PARK FOX, NATHAN A College Park, MD 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.
1R34DA050267-01
2/5 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 DUKE UNIVERSITY SMITH, PHILLIP BRIAN Durham, NC 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.
1R34DA050266-01
2/2 Optimizing access, engagement and assessment to elucidate prenatal influences on neurodevelopment: The Brains Begin Before Birth (B4) Midwest 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 Evanston, 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:

Though prenatal exposure to opioids and other substances have adverse effects on neurodevelopment, advances in neuroimaging and developmentally sensitive phenotypic measurement now enable characterization of typical and atypical brain-behavior pathways on an unprecedented scale. The Brains Begin Before Birth (B4) Midwest Consortium, a partnership of neuroscience, substance use, perinatal mental health, and child welfare scientists at Washington University School of Medicine (WUSM) and neuroscience, bioethics, pediatric population health, maternal-fetal, and addiction scientists at Northwestern University (NU). This regional consortium will leverage the contrasting approaches of Illinois (punitive) and Missouri (non-punitive) to prenatal opioid use, providing a platform for examining the impact of jurisdictional variations on science and practice. The consortium provide a framework for addressing three major areas of challenge: (1) legal/ethical, (2) recruitment/retention, and (3) imaging/assessment methods.