Funded Projects

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Project # Sort descending	Project Title	Research Focus Area	Research Program	Administering IC	Institution(s)	Investigator(s)	Location(s)	Year Awarded
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.
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.
1R34DA050270-01	1/3 Promoting Resilience in Children: Protocol Development for a Birth Cohort Study To Assess Factors Impacting Neurodevelopment	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	UNIVERSITY OF WISCONSIN-MADISON	GOLDSTEIN, ELLEN (contact); ZGIERSKA, ALEKSANDRA EWA	Madison, WI	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 first ten years of life are accompanied by rapid changes to the developing brain and cognitive abilities. Complex interacting factors including genetics, early-life exposure to substances, family and social interactions, and home and community environments can affect brain and cognitive development. Three linked projects aim to develop effective research protocols to lay a foundation for a future HEALthy Brain and Cognitive Development (HBCD) birth cohort study. Project 1 will develop protocols for recruitment and retention of a diverse sample of pregnant and postpartum women with oversampling of mothers with prenatal opioid use. Project 2 will identify ethical, legal, and regulatory challenges for investigations in this vulnerable population and define effective solutions to enable recruitment and study of these participants. Project 3 will develop and evaluate protocols for acquiring high-quality, quantitative neuroimaging measures with magnetic resonance imaging and functional near infrared spectroscopy and assess effective strategies for measuring cognitive performance in young children, including those exposed to opioids.
1R34DA050272-01	1/2 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	WASHINGTON UNIVERSITY	ROGERS, CYNTHIA ELISE (contact); SMYSER, CHRISTOPHER DANIEL	St. Louis, MO	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.
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.
1R34DA050284-01	1/5 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	WOMEN AND INFANTS HOSPITAL-RHODE ISLAND	DEONI, SEAN CL (contact); AMSO, DIMA ; D'SA, VIREN ANDREW; MUELLER, HANS-GEORG	Providence, RI	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.
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.
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.
1R34DA050287-01	4/4 Investigation of opioid exposure and neurodevelopment (iOPEN)	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	NEW YORK UNIVERSITY SCHOOL OF MEDICINE	THOMASON, MORIAH E (contact); BERGINK, VEERLE	New York, NY	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.
1R34DA050288-01	2/5 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	AVERA MCKENNAN	ELLIOTT, AMY J	Sioux Falls, SD	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.
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.
1R34DA050290-01	2/4 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 PITTSBURGH AT PITTSBURGH	PANIGRAHY, ASHOK (contact); KRANS, ELIZABETH E; LUNA, BEATRIZ	Pittsburgh,PA	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.
1R34DA050291-01	1/4 Investigation of opioid exposure and neurodevelopment (iOPEN)	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	OREGON HEALTH & SCIENCE UNIVERSITY	GRAHAM, ALICE M (contact); FAIR, DAMIEN A	Portland, OR	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.
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.
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.
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.
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.
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.
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.
1R34DA050343-01	3/6 Planning for the HEALthy Early Development Study	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	OSU CENTER FOR HEALTH SCIENCES	CROFF, JULIE MAY (contact); MORRIS, AMANDA S	Tulsa, OK	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.
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.
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.
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.
1U01DA055343-01	1/2 Assessing the Cumulative Impact of Early Life Substance and Environment Exposure on Child Neurodevelopment and Health	Enhanced Outcomes for Infants and Children Exposed to Opioids	HEALthy Brain and Child Development Study (HBCD)	NIDA	RHODE ISLAND HOSPITAL	DEONI, SEAN CL (contact); D'SA, VIREN ANDREW	Providence, RI	2021
NOFO Title: HEAL Initiative: HEALthy Brain and Child Development Study (Collaborative U01- Clinical Trial Not Allowed) NOFO Number: RFA-DA-21-020 Summary: This study aims to determine how exposure to opioids and other substances affects the developing fetal brain and shapes later child cognitive outcomes. Researchers will collect neuroimaging and behavioral data, as well as measures of environmental exposures related to social equity, COVID-19, and socioeconomic factors. The project will reduce traditional barriers to participation by using innovative data collection methods and mobile labs to bring the research to underrepresented and marginalized communities. This approach aims to clarify the impact of substance exposure on child development through an equitable approach to research, with generalizable findings. The study will take place at Rhode Island Hospital, where participants will be drawn from a largely rural population.