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About this paper symposium
| Panel information |
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| Panel 2. Biological Processes: Neuroscience and Genetics |
| Paper #1 | |
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| Overview, goals and structure of the Healthy Brain and Child Development Study | |
| Author information | Role |
| Charles A. Nelson, III, Ph.D., Harvard Medical School, United States | Presenting author |
| Abstract | |
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Human brain development is an intricate, protracted process that begins in the weeks following conception and extends until the third decade of life. In most cases, neurodevelopment proceeds along a typical trajectory; however, maladaptive experiences early in life can alter developmental trajectories, leading to harmful and enduring developmental sequelae. Prenatal hazards might include maternal substance exposure, such as opioids, cannabis and alcohol; postnatal hazards might include exposure to parental psychopathology, maltreatment, or excessive stress. These experiences can act singly and synergistically (with each other and with genetics) to shape neurodevelopment. Moreover, there are a multitude of factors that determine the extent to which these factors impact development, including their timing, duration, and severity, and the extent to which there are protective factors in a child’s life (such as a primary caregiver, an older sibling or a teacher). To elucidate how various environmental and experiential hazards impact development, the NIH-supported HBCD study has deployed a harmonized and innovative battery of neuroimaging (MRI, EEG) measures complemented by an armamentarium of behavioral, physiological, and psychological tools (while also collecting a range of biospecimens, including DNA, from both mothers and infants) to understand neurodevelopmental trajectories in a sample of 7,500 mothers and infants recruited in pregnancy and followed for the first decade of life. A quarter of the sample will be comprised of infants exposed prenatally to various substances; another quarter will be demographically matched to these families but with no substance exposure; and the remaining 50% will be drawn from a representative sample across the US. As of August 2024, more than 2000 families have already been recruited, with testing at all sites well underway. In addition, the first public data release will take place in January, 2025, with annual releases thereafter. This presentation will provide an overview to this project, with subsequent presentations discussing individual domains being investigated and preliminary findings. |
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| Paper #2 | |
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| HBCD Study Strategies to Recruit and Retain Participants Exposed to Adversity | |
| Author information | Role |
| Oziomachuckwu Chinaka, Virginia Polytechnic Institute and State University, United States | Presenting author |
| Brenda Jones Harden, Columbia University School of Social Work, United States | Non-presenting author |
| Lorraine McKelvey, University of Arkansas, United States | Non-presenting author |
| Abstract | |
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A primary goal of the HBCD study is to examine the influence of early adversity on young children’s brain and behavioral development. This goal presents challenges regarding the recruitment and retention (R&R) of appropriate participants. This presentation will address our strategies for recruiting and retaining affected families from both the HBCD consortium-level and site-specific personnel perspectives. Obviously, a study of this breadth and complexity, with a large sample of participants who have experienced adversity, requires carefully planned recruitment and retention strategies. The HBCD consortium has instilled various strategies to recruit and retain these populations. HBCD created the HBCD Recruitment/Retention workgroup that meets biweekly to address these issues, and has developed a range of materials to facilitate sites’ effective recruitment and retention of participants experiencing adversities. We also have received special funds from NIH to hire “study navigators”, individuals with “lived experience” (e.g., substance use histories) who can help us recruit and retain participants from high-risk backgrounds. Further, each site has a Community Advisory Board, which consists of parents, community members, and professionals with expertise in working with families experiencing adversity, which assists them with recruiting and retention planning. Though these strategies were established to aid sites in the consortium with the recruitment and retention of these individuals, more research needed to be conducted to understand how sites were actually recruiting and retaining their individuals. To that end, a descriptive evaluation was conducted using interviews to understand what recruitment and retention strategies were conducted at each site from the perspective of HBCD personnel. The data presented is a subset of the whole dataset and is preliminary. Interviews were completed with 30 HBCD personnel within their first-year recruitment period. Data from 15% (n=5) of the sample size was transcribed first by a machine through a captioning system and then transcribed verbatim and cleaned for accuracy by a human. A thematic analysis was conducted to identify themes and subthemes using inductive coding. The analysis provided themes of direct and indirect strategies utilized by multiple HBCD sites, such as word of mouth, flyers, relationship building, recovery centers, and others. Further analysis will be conducted with the total sample size to fully and comprehensively identify all strategies being utilized for the recruitment and retainment of these diverse individuals and to provide additional context to how consortium R&R resources (e.g., study navigators, Community Advisory Boards, etc.) are utilized across sites. |
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| Paper #3 | |
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| Assessing Child Behavior and Caregiver-Child Interactions in HBCD Using a Rigorous and Equitable Approach | |
| Author information | Role |
| Amanda Sheffield Morris, Department of Psychology, Oklahoma State University, United States | Presenting author |
| Renee C. Edwards, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Institute for Innovations in Developmental Science, Northwestern University, United States | Non-presenting author |
| Elizabeth Planalp, Waisman Center, University of Wisconsin-Madison, United States | Non-presenting author |
| Michelle Bosquet Enlow, Boston Children's Hospital and Harvard Medical School, United States | Non-presenting author |
| Marianne Brennan, Institute for Innovations in Developmental Science, Northwestern University, United States | Non-presenting author |
| Lauren S. Wakschlag, Department of Medical Social Sciences, Northwestern University and Institute for Innovations in Developmental Science, Northwestern University, United States | Non-presenting author |
| Abstract | |
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The HEALthy Brain and Child Development (HBCD) study provides a unique opportunity for interdisciplinary collaboration to elucidate factors that influence developmental trajectories of growth and socioemotional functioning. In this landmark study of neurodevelopment, it is crucial to have valid, developmentally sensitive assessments of child behavior and the caregiving environment. Indeed, brain development occurs in context, and the caregiver-child and family context are malleable factors that can be targeted for intervention. The HBCD Child Behavior and Caregiver-Child Interaction Workgroup designs and leads the assessment of these domains for this longitudinal study that aims to recruit 7,500 families across 27 sites in the US, targeting pregnant people prenatally with the intent to follow families for at least 10 years. This presentation will discuss the processes and measures chosen and implemented for the HBCD Study, with a particular focus on our equity elaboration processes and training. A major focus of our workgroup has been the adaptation and testing of the Early Regulation in Context Assessment (ERICA), a behavioral observation paradigm that uses “presses” to efficiently elicit variability in child and caregiver behavior (Wakschlag, et al., 2008). Adapted from the well-validated DB-DOS, the ERICA utilizes a series of simple, everyday activities that “press” for frustration or enjoyment/pleasure and (e.g., tummy time, messy and free play, busy parent/caregiver). In addition to the ERICA, we also adopt a Friendly Unfamiliar Adult episode (adapted from the Lab-TAB) to elicit inhibitory behaviors, and a Structured Play task which will use the ERICA scoring system. A critical pragmatic feature our team has developed is a one pass, centralized coding system with simplified codes for all behavioral tasks. This time efficient approach to coding will facilitate the availability of observational data in real time when the dataset is publicly released. For the ERICA and Play, codes include three child (positive affect, irritability, social engagement) and three caregiver (responsive behavior, irritable behavior, directive behavior) codes and a dyadic code of connectedness. For the FUA, codes include child behavioral inhibition across several domains. Another innovation includes incorporation of recommendations from experts in culturally sensitive caregiver-child assessment, which led to our reducing the evaluative and potentially ethnocentric bias inherent in traditional coding systems. We also include the Family Culture Matters activity, a Q-sort measure of parents’ socialization goals, which asks caregivers to rank the importance of different child qualities, e.g., obedience, kindness. These data will be utilized in combination with the ERICA to consider how socialization goals may affect parenting. Our symposium presentation will discuss the development and piloting of the ERICA-FCM as well as other measures included in the HBCD standardized behavioral assessment battery (see Table 1), which currently includes data from over 2,000 pregnant women/people (limited data will be released in January, 2025). Reliability and validity of the one-pass coding system will also be featured as part of the symposium. We will discuss challenges and opportunities for behavioral assessments in studies such as HBCD and the principles that have guided the decisions made by our working group. |
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| Paper #4 | |
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| Ethics and the Idea of Participant Vulnerability in the HBCD Study | |
| Author information | Role |
| Pilar Nicole Ossorio, University of Wisconsin-Madison, United States | Presenting author |
| Abstract | |
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Introduction: The Healthy Brain and Child Development (HBCD) study recruits many participants who are treated as “vulnerable” under the U.S. research ethics regulations (Common Rule). The concept of vulnerability has long been integrated into research ethics regulations. However, bioethicists have criticized this regulatory concept as too narrowly focused on conditions that compromise participants’ decisional autonomy, lacking theoretical underpinning, lacking coherence, and inappropriately focused on traits or categories of participants rather than the researcher-participant relationship. Under the regulations, IRBs can require that a research protocol include unspecified “additional safeguards… to protect the rights and welfare” of vulnerable participants (45 CFR 46.111(b). In this paper we develop theory regarding vulnerability in research as an intersectional and relational concept. This theoretical underpinning helps us determine what additional safeguards are appropriate. We discuss some safeguards HBCD is implementing. Hypothesis: This work is embedded ethics in an observational study. We do not experimentally test a hypothesis. However, we argue that researchers and IRBS need a theory of vulnerability to understand what additional protections are appropriate for participants in any given study. Study population: The HBCD study is recruiting over 7000 pregnant persons and their later-born children (over 14,000 parent-child dyads) with the aim of assessing the children’s brain, behavioral, emotional, and cognitive development over their first ten years. The study is oversampling persons who use substances during pregnancy. The study sample is designed to closely reflect the U.S. population on several dimensions, including income, education, race/ethnicity (using OMB-specified categories for external validity), urbanicity/rurality, and neighborhood quality (neighborhood deprivation index). HBCD participants can fall into several regulatory categories of vulnerability, such as a person who is pregnant, using opioids, and has low literacy and low income. Such persons can be viewed as having multiple and overlapping identities or social positions related to vulnerability in research. Results: We follow many ethicists in viewing vulnerability as a justice concern that goes beyond the Common Rule’s focus on participants’ susceptibility to coerced research participation. We draw on bioethics scholarship on vulnerability by Samia Hurst, Gail Henderson, and Kenneth Kipness; on work of political philosophers and theorists of diversity in democracy, such as Iris Marion Young, her followers, and her critics; and on socio-legal theories of intersectionality. We explain how the larger social context in which some groups of people are marginalized, exploited, disempowered, and disproportionately targeted for violence can help explain why and how some people are particularly vulnerable in a researcher-participant relationship. Focusing on the relationship emphasizes vulnerability not as a trait or condition of participants but as a situation in which researchers are susceptible to disproportionately burdening, harming, or disrespecting some groups of participants. This theory helps understand what types of interventions might create a more just set of research relations. We discuss HBCD’s educational interventions for investigators, SoPs, and monitoring procedures designed to counteract vulnerability and improve justice in research. |
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Healthy Brain and Child Development (HBCD) Study: Charting Development Across the First Years of Life
Submission Type
Paper Symposium
Description
| Session Title | Healthy Brain and Child Development (HBCD) Study: Charting Development Across the First Years of Life |