Lakota Family Acceptance Program for Depression and Anxiety

(L-FAP Trial)

Recruiting at 1 trial location

Overseen By Katie Edwards (Principal Investigator), PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Suicide risk, Psychosis symptoms

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

28 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on developing a supportive program for Indigenous 2SLGBTQ+ youth and their caregivers, aiming to reduce depression and anxiety by promoting family acceptance. Participants will engage in an 8-week program to determine if family support can improve mental health. The trial seeks Indigenous 2SLGBTQ+ youth, aged 13 to 18, who experience family rejection and can attend sessions with a supportive caregiver. As an unphased trial, this study offers a unique opportunity to contribute to meaningful research that could enhance mental health support for Indigenous 2SLGBTQ+ communities.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program is safe for participants?

Research has shown that the Adapted Lakota Family Acceptance Program is safe, suitable, and practical for Indigenous 2SLGBTQ+ youth and their families. This program helps families support their youth, increasing pride and hope while aiming to reduce mental health issues like depression and anxiety.

No specific problems or safety concerns have been reported in the information provided. This trial examines how well participants receive the program sessions and whether they cause any issues. As an initial trial, it primarily assesses the safety and effectiveness of the sessions for participants.

Although detailed safety data from past trials is lacking, the program's focus on suitability and practicality suggests it prioritizes participant well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Lakota Family Acceptance Program (LFAP) is unique because it brings cultural relevance into the treatment of depression and anxiety, particularly for individuals from the Lakota community. Unlike standard therapies, which often rely on medication or generalized cognitive-behavioral approaches, LFAP integrates traditional Lakota values and family involvement to promote mental wellness. Researchers are excited about this program because it has the potential to not only address mental health symptoms but also strengthen family bonds and cultural identity, offering a holistic approach that resonates deeply with participants’ cultural backgrounds.

What evidence suggests that the Adapted Lakota Family Acceptance Program is effective for depression and anxiety?

Research has shown that the Adapted Lakota Family Acceptance Program (LFAP) aims to improve mental health by fostering family support and acceptance, particularly for Indigenous 2SLGBTQ+ youth. Studies have found that programs focusing on family acceptance can help reduce depression and anxiety. The program seeks to boost youth pride and hope for the future, which are crucial for lowering mental health risks. Although direct evidence on this specific program's effectiveness is limited, the concept of strengthening family bonds has been linked to better mental health. Early findings suggest that culturally grounded programs like this one may effectively address mental health challenges by creating supportive family environments. ^{1 3 4 5 6}

Who Is on the Research Team?

Katie Edwards, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for Indigenous 2SLGBTQ+ youth aged 13-18 experiencing issues like depression, anxiety, or family stress due to rejection. They must be able to attend eight weekly sessions with a caregiver who's aware of their identity and can also participate. Caregivers include parents or other adults responsible for the youth.

Inclusion Criteria

I identify as 2SLGBTQ+ and my caregiver is aware of my identity.

I identify as Indigenous, including if I am multiracial.

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey

Participants complete a baseline survey before starting the intervention

1 week

1 visit (in-person or virtual)

Intervention

Participants engage in the Lakota-adapted Family Acceptance Project, consisting of 8 weekly sessions

8 weeks

8 visits (in-person)

Immediate Follow-up

Participants complete a follow-up survey immediately after the intervention

1 week

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in outcomes such as depression, anxiety, and family acceptance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Adapted Lakota Family Acceptance Program

Trial Overview

The Lakota Family Acceptance Project aims to adapt support programs for Indigenous 2SLGBTQ+ youth and their caregivers. It tests if these adapted sessions are acceptable, feasible, safe, and effective in reducing negative feelings like depression by tracking changes before and after the program.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

There is only one arm in this OPT and that is the intervention group that will participate in the 8-session LFAP intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07326748

NCT07326748 | Lakota Family Acceptance Project

The program aims to strengthen families, increase youth pride and hope for the future, and reduce mental health risks such as depression, ...

2.

reporter.nih.gov

reporter.nih.gov/search/8pfR3_iHGEytobw-sNqcRA/project-details/10786913

Project Details

The proposed project aims to adapt and evaluate the first ever culturally grounded, family-based program to prevent mental health and related problems among ...

3.

withpower.com

withpower.com/trial/phase-depression-2026-a5717

Lakota Family Acceptance Program for Depression and ...

... Adapted Lakota Family Acceptance Program will have tolerable side effects & efficacy for patients with Depression, Anxiety Disorders, Relationship or Family ...

4.

ivrl.ssw.umich.edu

ivrl.ssw.umich.edu/tiwahe-tewichaglapi

Lakota Family Acceptance Project

Reduce problems such as depression, anxiety, substance abuse, dating violence, and suicide. Promote bright, happy, and thriving futures for 2SLGBTQ+ Lakota ...

5.

adaa.trialstoday.org

adaa.trialstoday.org/trial/NCT07326748

Anxiety & Depression Association of America

The goal of this open pilot trial (OPT) is to develop a Lakota-adapted Family Acceptance Project (LFAP) for Indigenous 2SLGBTQ+ youth and their ...

6.

ctv.veeva.com

ctv.veeva.com/study/lakota-family-acceptance-project

Lakota Family Acceptance Project - ClinicalTrials.Veeva

The OPT is specifically focused on acceptability, feasibility, and safety of programming and research protocols. We will also examine pre- to ...