RecruitingNot Applicable

The Trans-Led Care Study

United States124 participantsStarted 2025-02-10

Plain-language summary

This study is testing a new mutual-help group called "the TLC program" for transgender adults who use substances or are recently in recovery. The TLC Program is based on Acceptance and Commitment Therapy or "ACT" which is a type of mental health counseling that focuses on using mindfulness skills to connect a person to their values and improve their mental health. The TLC Program was developed by transgender and gender diverse community members, mental health providers, and researchers.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. be 18 years of age or older;
. speak primarily English;
. live in the U.S.;
. have a gender identity different from their assumed gender, or sex assigned, at birth;
. identify as a person of transgender experience;
. endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Gender Minority Stress and Resilience Scale Internalized Transphobia

Timeframe: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Health Care Empowerment Inventory

Timeframe: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Patient-Reported Outcomes Measurement Information System (PROMIS)

Timeframe: Reported weekly, as well as at baseline assessment, post assessment (12 weeks), and follow-up assessment (24 weeks)

Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)

Timeframe: Reported at baseline assessment

The Acceptability of Intervention Measure (AIM)

Timeframe: Reported at post-assessment (12 weeks)

Intervention Appropriateness Measure

Timeframe: Reported at post-assessment (12 weeks)

Trial details

NCT IDNCT06880705

SponsorIllinois Institute of Technology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-31

Contact for this trial

Arryn Guy, PhD

312-567-6467 aguy1@iit.edu

View on ClinicalTrials.gov More Substance Abuse trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. be 18 years of age or older;
. speak primarily English;
. live in the U.S.;
. have a gender identity different from their assumed gender, or sex assigned, at birth;
. identify as a person of transgender experience;
. endorse having experienced two or more problem(s) related to alcohol or other drug use within the past 12 months.

What they're measuring

Gender Minority Stress and Resilience Scale Internalized Transphobia

Timeframe: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Health Care Empowerment Inventory

Timeframe: Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Patient-Reported Outcomes Measurement Information System (PROMIS)

Timeframe: Reported weekly, as well as at baseline assessment, post assessment (12 weeks), and follow-up assessment (24 weeks)

Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)

Timeframe: Reported at baseline assessment

The Acceptability of Intervention Measure (AIM)

Timeframe: Reported at post-assessment (12 weeks)

Intervention Appropriateness Measure

Timeframe: Reported at post-assessment (12 weeks)