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NOT YET RECRUITING

NCT07865858

Lakota Family Acceptance Project Pilot RCT

Sponsor: University of Michigan

View on ClinicalTrials.gov

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.

Official title: Development and Evaluation of an Indigenized Family Acceptance Project for Lakota 2SLGBTQ+ Teens (PHASE III: PILOT RANDOMIZED CONTROLLED TRIAL )

Key Details

Gender

All

Age Range

13 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10-10

Completion Date

2027-01-31

Last Updated

2026-10-08

Healthy Volunteers

Yes

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

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.

Inclusion Criteria: Youth Inclusion Criteria: 1. Identify as 2SLGBTQ+ (and their identity must be known to their participating caregiver) 2. Identify as Indigenous (multiracial youth who are also Indigenous are eligible) 3. Youth should be between the ages of 13 and 18 years old 4. Read and speak English 5. Report moderate to high levels of caregiver/family rejection (as evidenced by agreement on items that assess the presence and frequency of specific family rejecting behaviors \[includes ambivalent and moderately and highly rejecting caregivers\] AND/OR report the absence of supportive/advocacy behaviors (as evidenced by lack of agreement on one or more items assessing supportive/advocacy behaviors) \[if caregivers report this and youth do not, the dyad still meets criteria\]. 6. Report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their caregiver. 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. 1. Must be over the age of 18 2. Read and speak English 3. Be aware of the SGM identity of their Indigenous 2SLGBTQ+ youth 4. Report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their teen 5. Report moderate to high levels of caregiver rejection (as evidenced by agreement on one or more items that assess the presence and frequency of specific caregiver rejecting behaviors \[includes ambivalent and moderately and highly rejecting caregivers\] AND/OR report the absence of supportive/advocacy behaviors (as evidenced by lack of agreement on one or more items assessing supportive/advocacy behaviors) \[if youth report this and caregivers do not, the dyad still meets criteria\]. Exclusion Criteria: * We will exclude Indigenous 2SLGBTQ+ youth and caregivers at imminent risk for suicide and/or who are experiencing current psychosis symptoms as determined by results on the safety items screener.

Locations (2)

Wahwala Iyohlogya/Peaceful Means

Pine Ridge, South Dakota, United States

University of Michigan

Rapid City, South Dakota, United States