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New program aims to support lakota two spirit youth and their families

NCT ID NCT07326748

Knowledge-focused Sponsor: University of Michigan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This pilot study is testing a program called Tiwahe Tewichaglapi, which adapts the Family Acceptance Project for Lakota 2SLGBTQ+ youth and their caregivers. The goal is to see if the program is acceptable, safe, and feasible, and to check if it helps reduce depression, anxiety, and suicide risk. About 28 youth and their caregivers will take part in 8 weekly group sessions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tiwahe Tewichaglapi (The Family Loves Them) - a culturally grounded, family-centered behavioral intervention
What this could lead to
If successful, this could point toward a culturally tailored way to improve family support and mental health for Indigenous 2SLGBTQ+ youth.
What could go wrong
This is a very small early pilot study with only 28 participants, so results may not apply broadly. The focus is on feasibility, not proof of effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

21 people

The number who actually took part.

Started

Jan 2026

Finished

Aug 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder substance abuse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Depression Drug use Family relationships LGBTQ Minority stress Racial disparities Sexual risk reduction Teen dating violence

Contacts and locations

Locations

  • He Sapa New Life Wesleyan Church

    Rapid City, South Dakota, 57701, United States

  • Wahwala Iyohlogya/Peaceful Means

    Pine Ridge, South Dakota, 57770, United States

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