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Not yet recruiting Not applicable Interventional Accepts healthy volunteers

Lakota Family Acceptance Project Pilot RCT

ClinicalTrials.gov ID: NCT07865858

Public ClinicalTrials.gov record NCT07865858. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 9, 2026, 2:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT07865858
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
University of Michigan
Other
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
13 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 10, 2026 (Estimated)
Primary completion
Jan 31, 2027 (Estimated)
Completion
Jan 31, 2027 (Estimated)
Last update posted
Oct 8, 2026

2026 – 2027

United States locations

U.S. sites
2
U.S. states
1
U.S. cities
2
Facility City State ZIP Site status
Wahwala Iyohlogya/Peaceful Means Pine Ridge South Dakota 57770 —
University of Michigan Rapid City South Dakota 57701 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07865858, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 8, 2026 · Synced Oct 9, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07865858 live on ClinicalTrials.gov.

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