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

项目摘要/摘要 阿片依赖在美国的流行以及随之而来的阿片依赖数量的增加 出生时患有新生儿阿片类药物戒断综合征的婴儿不仅可能严重影响 现在的几代人和未来的一代也是如此。ACT现在对接触阿片类药物的婴儿的结果 (双簧管)研究是一项纵向队列研究，旨在前瞻性地检查从出生到2岁的纵向结局 与匹配的对照组相比，在宫内接触阿片类药物的婴儿的年龄。这个 ACT NOW双簧管研究的目标是(1)确定产前阿片类药物暴露对 生命头两年的大脑结构和连接性；(2)定义医学、发育和 暴露于阿片类药物的婴儿在出生后头两年的行为结果；以及(3)探索 以及家庭环境、母亲心理健康和育儿方式如何改变大脑的轨迹 在生命的头两年，连接性和神经发育。双簧管研究联盟包括 四个临床站点(凯斯西大学、宾夕法尼亚儿童医院、辛辛那提儿童医院 医院医疗中心和阿拉巴马大学伯明翰分校)，一个独立的数据协调 RTI国际中心和国家儿童医学中心的神经成像核心。这 行政副刊将通过采用创新的方法来加强双簧管研究的影响 吸引更多样化的研究人群，从而提高研究结果的概括性。至 解决从代表性不足的人群中招募研究参与者的挑战，研究小组将 定制并利用基于以下内容开发的创新研究理解和同意辅助工具 传播学的前沿研究。这项行政副刊的具体目的是 现在行动双簧管研究是(1)设计、定制和实施电子知情同意工具，以 改善ACT NOW双簧管研究中的种族/民族多样性和包容性；(2)评估可用性和影响 关于按种族/族裔分列的研究登记和保留的电子知情同意工具；和(3)进行 促进参与者登记的外展。

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.