Lakota Family Acceptance Project Pilot RCT

Part of paid clinical trials in Pine Ridge, South Dakota.

Sponsor
University of Michigan
Study ID
NCT07865858
Status
Not Yet Recruiting

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Conditions

  • Anxiety
  • Depression
  • Drug Use
  • Family Relationships
  • LGBTQ
  • Minority Stress
  • Racial Disparities
  • Sexual Risk Reduction
  • Teen Dating Violence

Eligibility Criteria

Sex
ALL
Age
13 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Adapted Lakota Family Acceptance Program — BEHAVIORAL
    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.

Study Details

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. The researchers 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, the researchers will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews.

Key Dates

First listed
Oct 8, 2026
Start date
Oct 10, 2026
Status verified
Oct 2026
Primary completion
Jan 31, 2027
Completion
Jan 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intervention Group
    The intervention group that will participate in the 8-session LFAP intervention
  • No Intervention: Waitlist Control
    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.

Primary Outcome Measure

Suicidality (Youth and Caregivers) [ Time Frame: Enrollment (baseline), immediate post-test (2 months from baseline), and 6-month follow-up (8 months from baseline). ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Wahwala Iyohlogya/Peaceful MeansPine RidgeSouth Dakota57770-
University of MichiganRapid CitySouth Dakota57701-

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By research site
Wahwala Iyohlogya/Peaceful Means· Pine Ridge, SDUniversity of Michigan· Rapid City, SD

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