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Lakota Family Acceptance Project Pilot RCT

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
13 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Following the baseline survey, families will be randomly assigned to the treatment or wait-list control."
  • "Additionally, the researchers will assess the acceptability and feasibility of the FAP via program observations, post-session surveys, and exit interviews."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether the Family Acceptance Project can help families be more accepting and improve teens’ mental health and safety. It is for Indigenous LGBTQ2S+ teens and their caregivers in Rapid City, South Dakota, and the nearby Pine Ridge Indian Reservation. Families will be assigned by chance to start the program or join a waiting list.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Youth must be 13 to 18 years old.
  • Youth must identify as Indigenous. Youth who are Indigenous and another race may join.
  • Youth must identify as 2SLGBTQ+ (Two-Spirit, lesbian, gay, bisexual, transgender, or queer, or another related identity). Their caregiver must know about this identity.
  • Caregivers must be over 18 and provide care for the youth. They may be parents, grandparents, other relatives, or other caring adults.
  • Older siblings may be caregivers if they are at least 28 and care for and make decisions for the youth.
  • Both the youth and caregiver must read and speak English.
  • The youth or caregiver must report family rejection, mixed acceptance, or a lack of support for the youth’s identity. They do not both have to report this.
  • Both must be able and willing to attend eight sessions together: two hours each week for eight weeks.

Who can't join

  • Youth or caregivers cannot join if a safety check finds an immediate risk of suicide.
  • Youth or caregivers cannot join if a safety check finds current signs of psychosis, which can make it hard to tell what is real.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

SD