Funded Projects
Explore our currently funded projects. You may search with all three fields, then focus your results by applying any of the dropdown filters. After customizing your search, you may download results and even save your specific search for later.
Project # | Project Title | Research Focus Area | Research Program | Administering IC Sort descending | Institution(s) | Investigator(s) | Location(s) | Year Awarded |
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3U01DA055363-03S1
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12/24 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 | OREGON HEALTH & SCIENCE UNIVERSITY | SULLIVAN, ELINOR L (contact); GRAHAM, ALICE M; NAGEL, BONNIE J | Portland, OR | 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. |
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1U01DA055352-01
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1/6 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 | ARKANSAS CHILDREN'S HOSPITAL RES INST | OU, XIAWEI (contact); ACHESON, ASHLEY ; MCKELVEY, LORRAINE M | Little Rock, AR | 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 Arkansas Children’s Research Institute site is in a predominantly rural state with the second highest rate of opioid prescriptions in the U.S. |
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1U01DA055343-01
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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. |
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1R34DA050291-01
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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. |
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1R34DA050342-01
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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. |
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3U01DA055365-03S1
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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. |
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1U01DA055353-01
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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. |
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1U01DA055370-01
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21/24 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 WISCONSIN-MADISON | DEAN III, DOUGLAS CARL (contact); POEHLMANN-TYNAN, JULIE A | Madison, WI | 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 take place at the University of Wisconsin, Madison, where researchers will have access to a diverse group of people, including women with criminal justice involvement. |
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1R34DA050292-01
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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. |
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3U01DA055367-03S1
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23/24 HEALthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | WASHINGTON UNIVERSITY | ROGERS, CYNTHIA ELISE (contact); BOGDAN, RYAN H | 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. |
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1U01DA055355-01
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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. |
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1U01DA055349-01
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10/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | OSU CENTER FOR HEALTH SCIENCES | CROFF, JULIE MAY (contact); HAYS-GRUDO, JENNIFER ; MORRIS, AMANDA S | Tulsa, OK | 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 take place at Oklahoma State University Center for Health Sciences and recruit diverse people from an urban area, including American Indian populations. |
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1R34DA050285-01
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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. |
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1U01DA055357-01
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22/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | NIDA | VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY | HOWELL, BRITTANY ROLLINS (contact); BELL, MARTHA ANN ; HOSIG, KATHRYN W | Virginia | 2022 | |
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. |
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1R34DA050267-01
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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. |
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5U24DA055325-02
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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. |
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1U01DA055344-01
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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. |
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1U01DA055363-01
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12/24 Healthy Brain and Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | OREGON HEALTH & SCIENCE UNIVERSITY | SULLIVAN, ELINOR L (contact); GRAHAM, ALICE M; NAGEL, BONNIE J | Portland, OR | 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 take place at Oregon Health and Science University, giving researchers access to people in a region with very high rates of opioid misuse. |
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1R34DA050255-01
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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. |
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1R34DA050287-01
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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. |
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3U24DA055330-03S1
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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. |
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1U01DA055369-01
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14/24 The Healthy Brain & Child Development National Consortium | Enhanced Outcomes for Infants and Children Exposed to Opioids | HEALthy Brain and Child Development Study (HBCD) | NIDA | UNIVERSITY OF CALIFORNIA, SAN DIEGO | BANDOLI, GRETCHEN E (contact); GAHAGAN, SHEILA | San Diego, CA | 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 San Diego study site will recruit a diverse cohort of mother-infant pairs, including Hispanic and American Indian individuals. |
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1U01DA055371-01
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17/24 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 MINNESOTA | WILSON, SYLIA (contact); GEORGIEFF, MICHAEL K; ZILVERSTAND, ANNA | Minneapolis, MN | 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 take place at the University of Minnesota and will provide access to a largely rural population. |
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1R34DA050299-01
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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. |
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1R34DA050297-01
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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. |