Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study

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PROJECT SUMMARY/ABSTRACT The epidemic of opioid dependency in the United States and the subsequent increase in the number of infants born with neonatal opioid withdrawal syndrome has the potential to substantially affect not only current generations but future ones as well. The ACT NOW Outcomes of Babies with Opioid Exposure (OBOE) Study is a longitudinal cohort study to prospectively examine longitudinal outcomes from birth to 2 years of age among infants who were exposed to opioids in utero as compared to matched controls. The objectives of the ACT NOW OBOE Study are to (1) Determine the impact of antenatal opioid exposure on brain structure and connectivity over the first 2 years of life; (2) Define medical, developmental, and behavioral outcomes over the first 2 years of life in infants exposed to opioids; and (3) Explore whether and how the home environment, maternal mental health, and parenting modify trajectories of brain connectivity and neurodevelopment over the first 2 years of life. The OBOE Study Consortium includes four Clinical Sites (Case Western University, Children’s Hospital of Pennsylvania, Cincinnati Children’s Hospital Medical Center, and the University of Alabama at Birmingham), an independent Data Coordinating Center at RTI International, and a Neuroimaging Core at the Children’s National Medical Center. This administrative supplement will enhance the impact of the OBOE study by using an innovative approach to engage a more diverse study population and thereby improve the generalizability of the study findings. To address challenges in recruiting study participants from underrepresented populations, the study team will tailor and utilize an innovative study comprehension and consent assistance tool developed based on cutting-edge research in communication science. The specific aims of this administrative supplement to the ACT NOW OBOE study are to (1) Design, tailor, and implement an electronic informed consent tool to improve racial/ethnic diversity and inclusion in the ACT NOW OBOE Study; (2) Assess usability and impact of the electronic informed consent tool on study enrollment and retention by race/ethnicity; and (3) Conduct outreach to facilitate participant enrollment.