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?

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. We 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 they will participate 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 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+