An interventional study of Adapted Lakota Family Acceptance Program in LGBTQ, Racial Disparities and Family Relationships, sponsored by University of Michigan. Not yet recruiting at 2 sites in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
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.
Indigenous LGBTQ2S+ youth experience disproportionately high rates of mental health problems including depression, anxiety, and suicidality as well as related issues such as alcohol and drug initiation/use and dating and sexual violence. Our preliminary research also shows that Lakota LGBTQ2S+ youth and their adult caretakers perceived the Family Acceptance Project (FAP)-a family support approach that seeks to reduce family rejecting behaviors and increase family accepting behaviors in the context of the family's cultural world-as highly acceptable and likely to be impactful in reducing mental health and related problems of Indigenous LGBTQ2S+ youth. To date, despite its promise for reducing mental health and related problems among LGBTQ2S+ youth, FAP has not been rigorously evaluated. The purpose of the proposed study is to pilot evaluate FAP for Lakota youth (ages 13 to 18) and their families. We have assembled an interdisciplinary team of experts and Elders/Traditional Knowledge Keepers (TKKs), and the team will be comprised of \~10 Lakota LGBTQ2S+ youth on a Youth Advisory Board (YAB) and \~10 caregivers to Lakota LGBTQ2S+ youth on a Caregiver Advisory Board (CAB). 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. The proposed project aligns Goal 3 of the NIMH to identify targets for intervention via a rigorous pilot RCT with a highly marginalized and underserved population and the Healthy People 2030 Goals to eliminate health disparities, which includes reductions in violence and injury among LGBTQ2S+ youth and youth of color.
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Inclusion Criteria:
Youth Inclusion Criteria:
Inclusion Criteria:
Participating Caregiver Inclusion Criteria:
Caregivers are broadly defined and may include a biological parent, stepparent, grandparent, aunt/uncle, or other adult who provides care to the Indigenous 2SLGBTQ+ youth. It may also include older siblings who are 28 years old or older if they care for and make decisions for the minor.
Exclusion Criteria:
The intervention group that will participate in the 8-session LFAP intervention
Behavioral: Adapted Lakota Family Acceptance Program
Waitlisted Control group- Provide check-ins, provide resources, and offer participants in this arm the same intervention program as the intervention group after 6-month follow-ups and measurements have been completed.
Tiwahe Tewichaglapi ("The Family Loves Them") Program Overview Tiwahe Tewichaglapi is a culturally grounded, family-centered intervention adapted from the Family Acceptance Project® (FAP) to promote caregiver acceptance, respect, support, and family bonding for 2SLGBTQ+ Lakota youth. The program was developed in partnership with the Lakota Oyate to address family rejection rooted in colonization and historical trauma and to honor traditional Two Spirit roles that have long held important and respected places within Lakota communities. The program aims to strengthen families, increase youth pride and hope for the future, and reduce mental health risks such as depression, anxiety, substance use, dating violence, and suicide among 2SLGBTQ+ Lakota youth. The program includes eight family group sessions 2.5 hrs. each delivered by Lakota facilitators that include Lakota cultural and spiritual practices - including smudging, a Lakota prayer, and a shared meal.
Suicidality (Youth and Caregivers)
Participant responses to items from the Suicidal Ideation Attributes Scale to measure suicide and life-threatening behavior in the past month. The 5-item scale includes likert response options ranging from 0 = Never to 10 = Always with higher scores indicating an elevated risk for suicide planning or behavior.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline), and 6-month follow-up (8 months from baseline).
Depression (Youth and Caregivers)
Participant responses to depressive symptoms in the past two weeks using items from the Patient Health Questionnaire (PHQ-9). The 9-item scale includes likert options ranging from 0 = Not at all to 3 = Nearly every day. Higher scores indicate more depressive symptoms
Time frame: Enrollment (baseline), immediate post-test (2 months after baseline), and 6-month follow-up (8 months after baseline)
Adolescent Dating Violence (Youth)
Participant responses to victimization and perpetration experiences in the past 30 days using items from the Adolescent Relationship Harassment and Abuse Scale on the Youth Risk Behavior Survey. The victimization scale is 3 items and the perpetration scale is 3 items. Likert response options range from 0 = 0 times to 4-6 or more times. Higher scores indicate greater dating violence
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
Alcohol Use (Youth)
Participant responses to alcohol use items on the Youth Risk Behavior Survey. The 3-item scale assesses alcohol use in the past 30 days. Likert response options for items 1 and 2 range from 0 = 0 days to 6 = all 30 days. Item 3 is an 8 point scale ranging from 0 = I did not drink alcohol in the past 30 days to 8 = 10 or more drinks. Higher scores indicate greater alcohol use.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Drug Use (Youth)
Participant responses to items on drug use in the past 30 days from the Youth Risk Behavior Survey. The 8-item scale incudes likert response options ranging from 0 = 0 times to 5 = 40 or more times. Higher scores indicate greater drug use.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Anxiety (Youth and Caregivers)
Participant responses to items from the Generalized Anxiety Disorder Screener (GAD-7) to measure anxiety symptoms in the past two weeks. The 7-item scale includes likert response options ranging from 0 = not at all to 3 = Nearly every day. Higher scores indicate greater anxiety severity.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
School Engagement (Youth)
Participant response to school engagement items from the Hulsey et al., 2018 measure. The 5-item scale includes likert response options ranging from 1= Not at all true of me to 4 = Extremely true of me. Higher scores indicate increased school engagement.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
Sexual Risk Taking (Youth)
Risky Sexual Behavioral Items from the Youth Risk Behavior Survey with participants using a slider to indicate response options ranging from 0 to 100. Higher scores indicate greater sexual risk behavior in the past 30 days.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline).
(Intermediary Outcome) Caregiver Accepting and Rejecting Behaviors (Youth and Caregivers)
FAP-Reactions, Advocacy, Feelings/Experiences is a 34 item measure with a 4 point scale for items 1-30 0=Never to 3=Many times. Higher scores indicate more accepting behavior in the past 30 days. A 5 point scale for items 31-32 1=Very Upset to 5=Very Happy with higher scores indicating accepting behavior for item 31 and rejecting behavior for item 32; items 33-34 1=Extremely to 5=Not At All with higher scores indicating accepting behavior for item 33 and rejecting behavior for item 34 in the past 30 days. LGBTQ microaggressions and anti-LGBTQ attitudes (reactions and feelings from microaggressions) subscale is 8 items with a 5 point scale 0=Never to 4=All the time. Higher scores suggest experiencing more interpersonal microaggressions in the past 30 days.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
(Intermediary Outcome) Harsh Parenting (Youth and Caregivers)
Items from the Brief Family Relationship Scale to assess family conflict. The 6-item scale includes response options using a continuous slider scale ranging from 1 to 20. Higher scores indicate greater conflict.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
(Intermediary Outcome) Connection to Lakota Culture (Youth and Caregivers)
Participant responses to items on the Lakota Cultural Identity Scale. The 9-item scale includes likert response options ranging from 1 = Not at all to 4 = A lot. Higher scores indicate greater connection to Lakota culture.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
(Intermediary Outcome) Connection to Community (Youth and Caregivers)
Participant responses to the Sense of Community Index. The 25-item scale includes likert response options ranging from 1 = Not at all to 4 = Very Important. Higher scores indicate greater sense of community.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
(Intermediary Outcome) Ethnic Identity (Youth)
Participant responses to the Multi-group Ethnic Identity Scale. The 12-item scale includes likert response options ranging from 1 = Strongly disagree to 4 = strongly agree. Higher scores indicate greater sense of ethnic identity.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
(Intermediary Outcome) Internalized LGBTQ+ phobia (Youth)
Participant responses to the 2017 LGBTQ+ Teen Survey. The 4-item scale includes response options ranging from 1= Strongly Disagree to 4= Strongly agree. Higher scores indicate increased feelings of internalized LGBTQ+ phobia.
Time frame: Enrollment (baseline), immediate post-test (2 months from baseline, and 6-month follow-up (8 months from baseline)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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