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

> **NIH NIH PL1** · RESEARCH TRIANGLE INSTITUTE · 2021 · $296,088

## Abstract

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.

## Key facts

- **NIH application ID:** 10400379
- **Project number:** 3PL1HD101059-01S2
- **Recipient organization:** RESEARCH TRIANGLE INSTITUTE
- **Principal Investigator:** CARLA M BANN
- **Activity code:** PL1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $296,088
- **Award type:** 3
- **Project period:** 2019-09-20 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10400379

## Citation

> US National Institutes of Health, RePORTER application 10400379, Administrative Supplement to Increase Participant Diversity, Inclusion and Engagement in the ACT NOW OBOE Study (3PL1HD101059-01S2). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10400379. Licensed CC0.

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