The Trans-Led Care Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIllinois Institute of Technology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • The TLC Program

    Behavioral

    Participants randomized to the TLC Program will receive TAU plus the telehealth, peer-delivered group intervention. The TLC Program was adapted from Acceptance and Commitment Therapy (ACT) - an acceptance and mindfulness-based third wave cognitive behavioral therapy. The intervention will be delivered in a group format with peer facilitators via telehealth using videoconferencing. The protocol covers all six ACT core concepts (i.e., contact with the present, acceptance, defusion, self-as-context, values, and committed action) with tailored examples and exercises focused on gender affirmation, internalized stigma, and substance use. Additional sessions are included defining stigma, how stigma affects physical and sexual health and engagement with healthcare, and values-driven self-care goals of substance use reduction and healthcare engagement. Sessions are approximately 1.5 hours each and are delivered over 12 weeks.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Treatment as Usual (TAU)No intervention 0 interventions
Group B: The TLC ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Gender Minority Stress and Resilience Scale Internalized Transphobia

Minimum value = 0, Maximum value = 1, Higher score = worse outcome

Time frame
Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
2

Health Care Empowerment Inventory

Minimum value = 1, Maximum value = 5, Higher score = better outcome

Time frame
Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
3

Patient-Reported Outcomes Measurement Information System (PROMIS)

Measuring psychological distress (depression and anxiety), Minimum value = 1 (per subscale), Maximum value = 5 (per subscale), Higher score = worse outcome

Time frame
Reported weekly, as well as at baseline assessment, post assessment (12 weeks), and follow-up assessment (24 weeks)
4

Psychological Flexibility, Multidimensional Psychological Flexibility Inventory (MPFI)

Minimum value = 1 (per subscale), Maximum value = 6 (per subscale), Higher score = worse outcome

Time frame
Reported at baseline assessment

Secondary outcomes

1

Substance Use Timeline Followback Interview

Time frame
Over the past 30 days
2

HIV Risk Questionnaire

Participants will be reporting number of sexual partners, types of sexual activities, and various HIV risk factors including condom use, PrEP use, and treatment as prevention

Time frame
Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Other outcomes

1

PTSD Life Events Checklist for DSM-5

Participants will indicate whether certain difficult or stressful life events they have experienced

Time frame
Reported at baseline assessment
2

Intersectional Discrimination Index (InDI)

Minimum value = 0, Maximum value = 13, Higher score = worse outcome

Time frame
Reported at baseline assessment
3

Access to Gender Affirmation in Healthcare Questionnaire

Minimum value = 1, Maximum value = 5 Higher score = Better outcome

Time frame
Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)
4

Need for Gender Affirmation Questionnaire

Minimum value = 1, Maximum value = 5

Time frame
Reported at baseline assessment, post-assessment (12 weeks), and follow-up assessment (24 weeks)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Illinois Institute of Technology

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator