Institutional review boards (IRBs) function to regulate research for the protection of human participants. We share lessons learned from the development of an intertribal IRB in the Rocky Mountain/Great Plains Tribal region of the United States. We describe the process through which a consortium of Tribes collaboratively developed an intertribal board to promote community-level protection and participation in the research process. In addition, we examine the challenges of research regulation from a Tribal perspective and explore the future of Tribally regulated research that honors indigenous knowledge and promotes community accountability and transparency. We offer recommendations for researchers, funding agencies, and Tribal communities to consider in the review and regulation of research.

Background Culturally relevant interventions are needed to help American Indian and Alaska Native (AI/AN) teenagers and young adults navigate common risky situations involving family and friends, including drug and alcohol misuse, dating violence, and suicidality. Leveraging We R Native, a multimedia health resource for Native teenagers and young adults, staff of the Northwest Portland Area Indian Health Board designed the BRAVE intervention for Native youth. The program is delivered via SMS text messaging and includes role model videos, mental wellness strategies, links to culturally relevant resources, and social support from family and friends. Objective We aim to conduct a randomized controlled trial of the BRAVE intervention among AI/AN teenagers and young adults (aged 15-24 years) to assess its impact on their physical, mental, and spiritual health; their resilience and self-esteem; and their coping and help-seeking skills. Methods From October to December 2019, we recruited 2334 AI/AN teenagers and young adults nationwide via social media channels and SMS text messages and enrolled 1044 participants. AI/AN teenagers and young adults enrolled in the study received either BRAVE SMS text messages, designed to improve mental health, help-seeking skills, and cultural resilience, or 8 weeks of science, technology, engineering, and math (STEM) SMS text messages, designed to elevate and reaffirm Native voices in STEM and medicine and then received the BRAVE SMS text messages. The impacts of the BRAVE intervention were tested using linear mixed-effect models and linear regressions. Results A total of 833 AI/AN teenagers and young adults were included in the analysis. Individuals in the BRAVE and STEM arms showed significant positive trends over the course of the study for all outcomes, except cultural identity and help-seeking behavior. Mean scores were significantly different for health (P<.001), resilience (P<.001), negative coping (P=.03), positive coping (P<.001), self-efficacy (P=.02), and self-esteem (P<.001). Changes in help-seeking self-efficacy were significant in those exhibiting risky behaviors at baseline to exit (P=.01). Those who reported positive coping scores at baseline also reported better health on average; however, no difference was found in risky drug and alcohol use (P<.001). The number of participants who used SMS text messages to help themselves increased from 69.1% (427/618) at 3 months to 76% (381/501; P<.001) at 8 months. Similarly, the number of participants who used SMS text messages to help friends or family members increased from 22.4% (138/616) at 3 months to 54.6% (272/498) at 8 months. Conclusions This is the first national randomized controlled trial of a mobile health intervention among AI/AN teenagers and young adults to test the efficacy of a mental wellness intervention in relation to STEM career messages. This study provides new insights for supporting the next generation of AI/AN changemakers. Trial Registration ClinicalTrials.gov NCT04979481; https://clinicaltrials.gov/ct2/show/NCT04979481

This paper shares lessons learned recruiting and engaging participants in the BRAVE study, a randomized controlled trial carried out by the Northwest Portland Area Indian Health Board and the mHealth Impact Lab. The team recruited 2330 American Indian/Alaska Native (AI/AN) teens and young adults nationwide (15–24 years old) via social media channels and text message and enrolled 1030 to participate in the 9 month study. Teens and young adults who enrolled in this study received either: 8 weeks of BRAVE text messages designed to improve mental health, help-seeking skills, and promote cultural pride and resilience; or 8 weeks of Science Technology Engineering and Math (STEM) text messages, designed to elevate and re-affirm Native voices in science, technology, engineering, math and medicine; and then received the other set of messages. Results indicate that social media channels like Facebook and Instagram can be used to recruit AI/AN teens and young adults. Retention in this study was high, with 87% of participants completing both the BRAVE and STEM intervention arms. Lessons learned from this process may help teen and young adult-serving organizations, prevention programs, policy makers, researchers, and educators as they support the next generation of AI/AN change makers.

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