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Life sciences · Interventional Study
ClinicalTrials.gov · October 8, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07865858). This is a study registration, not published results. Lead sponsor: University of Michigan. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: LGBTQ, Racial Disparities, Family Relationships, Minority Stress, Depression, Anxiety, Drug Use, Teen Dating Violence, Sexual Risk Reduction. Interventions: BEHAVIORAL: Adapted Lakota Family Acceptance Program. Primary outcome measures: Suicidality (Youth and Caregivers) , Enrollment (baseline), immediate post-test (2 months from baseline), and 6-month follow-up (8 months from baseline).; Depression (Youth and Caregivers) , Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline). Brief summary: Although research documents the concerning rates of mental and behavioral health problems (e.g., substance use/initiation) among Indigenous LGBTQ2S+ youth, there is very little known about how to prevent these deleterious issues that devastate Indigenous communities. The study will include \~40 families (Lakota LGBTQ2S+ youth and caregivers) in Rapid City, SD (20 families (10 FAP; 10 wait-list control) and on the nearby Pine Ridge Indian Reservation (10 FAP; 10 wait-list control). Following the baseline survey, families will be randomly assigned to the treatment or wait-list control. Participants will complete an immediate post-test and 6-month follow-up survey to test the hypotheses that FAP will lead to changes in targets, specifically increases in caregiver accepting behaviors, youth and caregiver connection to Lakota culture, family bonding, and youth future orientation and decreases in caregiver rejecting behaviors, caregiver harsh parenting, and youth internalized homo/bi/transphobia compared to the control condition. We will also examine the hypotheses that there will be reductions in deleterious primary outcomes (depressive symptoms, anxiety symptoms, suicidality) and secondary outcomes (alcohol and drug use/initiation and dating and sexual violence victimization and perpetration) among youth in the treatment conditions compared to the control condition. Additionally, we will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews.