| NCT ID | NCT07326748 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | LGBTQ |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2026-01-20 with a primary completion date of 2027-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Katie Edwards, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07326748 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, studying LGBTQ. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07326748 currently recruiting?
Yes, NCT07326748 is actively recruiting participants. Contact the research team at edkatie@umich.edu for enrollment information.
Where is the NCT07326748 trial being conducted?
This trial is being conducted at Pine Ridge, United States, Rapid City, United States.
Who is sponsoring the NCT07326748 clinical trial?
NCT07326748 is sponsored by University of Michigan. The principal investigator is Katie Edwards, PhD at University of Michigan. The trial plans to enroll 28 participants.