Lakota Family Acceptance Project

NCT07326748 | Recruiting DMC

• 2 other identifiers: HUM002640297R34MH134937-02
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their caregivers. The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. The investigators will also examine pre- to post- changes on outcomes for the sole purposes of making sure scores on measures are changing in the hypothesized direction (e.g., depression scores are going from moderate to minimal as opposed to no change or depression scores increasing). Once enrolled in the study, participants complete a baseline survey. Then participants will engage in LFAP which is an 8-session group intervention; sessions will be scheduled once a week for eight weeks (at 2 hours per session). Participants will complete survey instruments before and immediately after the program sessions, in addition to post-program surveys and an exit interview.

Conditions

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

Keywords

family acceptance; LGBTQ; 2SLGBTQ+; youth; family support; parents of LGBTQ youth; Racial/Ethnic Minority; health equity; Native American/Indigenous; Two Spirit

Outcome Measures

Primary Outcomes (3)

• 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 severity of suicidal ideation.

  Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• 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.

  Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• 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.

  Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

Secondary Outcomes (5)

• Adolescent Dating Violence (Youth)

  Past 30 days at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• Alcohol Use (Youth)

  Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• Drug Use (Youth)

  Past 30 days at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• School Engagement (Youth)

  Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• Sexual Risk Taking (Youth)

  Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

Other Outcomes (7)

• (Intermediary Outcome) Caregiver Accepting and Rejecting Behaviors (Youth and Caregivers)

  Past 30 days pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• (Intermediary Outcome) Harsh Parenting (Youth and Caregivers)

  Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

• (Intermediary Outcome) Connection to Lakota Culture (Youth and Caregivers)

  Collected during the pre-test (enrollment) and post-test (within 1 week of intervention conclusion).

Study Arms (1)

Intervention

OTHER

There is only one arm in this OPT and that is the intervention group that will participate in the 8-session LFAP intervention

Behavioral: Adapted Lakota Family Acceptance Program

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. Tiwahe Tewichaglapi includes eight family-centered group sessions delivered by Lakota facilitators. Each session begins with Lakota cultural and spiritual practices - including smudging, a Lakota prayer, and a shared meal - to ground the

Intervention

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Identify as 2SLGBTQ+ (and their identity must be known to their participating caregiver)
• Identify as Indigenous (multiracial youth who are also Indigenous are eligible)
• Youth should be between the ages of 13 and 18 years
• Read and speak English
• 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 \[includes ambivalent and moderately and highly rejecting caregivers\]
• Report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their caregiver
• 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
• Must be over the age of 18
• Read and speak English
• Be aware of the SGM identity of their Indigenous 2SLGBTQ+ youth
• report an ability and commitment to attending eight sessions at two hours a week over eight weeks with their teen

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Wahwala Iyohlogya/Peaceful Means

Pine Ridge, South Dakota, 57770, United States

RECRUITING

University of Michigan/Rapid City

Rapid City, South Dakota, 57701, United States

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Katie Edwards, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Edwards (Principal Investigator), PhD

CONTACT

734-647-8812; edkatie@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Social Work

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 8, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

US (2)