Lakota Family Acceptance Project (NCT07326748) | Clinical Trial Compass
RecruitingNot Applicable
Lakota Family Acceptance Project
United States28 participantsStarted 2026-01-20
Plain-language 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.
Who can participate
Age range
13 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Youth Inclusion Criteria:
* 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
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
* 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
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Suicidality (Youth and Caregivers)
Timeframe: Past month at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
2
Depression (Youth and Caregivers)
Timeframe: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).
3
Anxiety (Youth and Caregivers)
Timeframe: Past 2 weeks at pre-test (enrollment) and post-test (within 1 week of intervention conclusion).