Coping Skills Intervention for Mental Health in Sexual and Gender Minority Youth

(AFFIRM Trial)

Recruiting at 6 trial locations

Overseen By Andrew D Eaton, MSW

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Disqualifiers: High suicidality risk, others

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

Compensation: Varies

Number of Visits: 11

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests AFFIRM, a group program for LGBTQ+ youth. It uses CBT techniques to help them manage stress, change negative thoughts, and build supportive social networks.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on coping skills for mental health and does not mention medication requirements.

Is the Coping Skills Intervention for Mental Health in Sexual and Gender Minority Youth safe?

The AFFIRM intervention, which is a type of coping skills therapy, has been studied for its effectiveness in reducing distress and improving coping in sexual and gender minority youth. While specific safety data is not detailed in the available research, cognitive-behavioral therapies like AFFIRM are generally considered safe for use in humans. ^{1 2 3 4 5}

How is the AFFIRM treatment different from other treatments for mental health in sexual and gender minority youth?

AFFIRM is unique because it is a brief, affirmative cognitive-behavioral group therapy specifically designed to reduce distress and improve coping skills among sexual and gender minority adolescents and young adults, addressing their unique stressors and mental health needs. ^{2 6 7 8 9}

What data supports the effectiveness of the treatment AFFIRM for mental health in sexual and gender minority youth?

The study on AFFIRM shows it is effective in reducing distress and improving coping skills among sexual and gender minority youth, which suggests it can help improve mental health in this group. ^{1 2 6 7 10}

Who Is on the Research Team?

Shelley L Craig, PhD

Principal Investigator

Professor

Are You a Good Fit for This Trial?

This trial is for young individuals aged 14 to 29 who identify as part of the sexual and/or gender minority community, can communicate fluently in English, and are interested in an intervention called AFFIRM. It's not suitable for those needing more intensive therapy or currently in crisis with a high risk of suicidality.

Inclusion Criteria

Reads, writes, and speaks fluent English

I identify as part of the LGBTQ+ community.

I am willing to participate in an 8-session program.

Exclusion Criteria

My condition requires a stronger treatment approach.

You are currently experiencing a serious crisis and are at a high risk of feeling suicidal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY.

8 weeks

8 sessions (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

3 visits (in-person or virtual) at 6-month and 1-year follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• AFFIRM

Trial Overview AFFIRM, an 8-session group program designed to help reduce sexual risks and mental distress by affirming sexual and gender identities through education and role-play exercises. The study spans five years using a stepped wedge design where participants receive the intervention at different times.

How Is the Trial Designed?

Group I: AFFIRM Experimental Treatment 1 Intervention

AFFIRM is an 8-session psychoeducational weekly group intervention

Group II: Waitlisted control Active Control 1 Intervention

Waitlisted control

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Efficacy of affirmative cognitive behavioural group therapy for sexual and gender minority adolescents and young adults in community settings in Ontario, Canada. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Resilience to Discrimination and Rejection Among Young Sexual Minority Males and Transgender Females: A Qualitative Study on Coping With Minority Stress. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Examining stress and coping as a mediator for internalizing symptomatology: A comparison between sexual minority and majority first-year college students. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Gender and Sexual Identities Predicting Patterns of Co-occurring Health Risks Among Sexual Minority Youth: a Latent Class Analysis Approach. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Predicting the Transition From Suicidal Ideation to Suicide Attempt Among Sexual and Gender Minority Youths. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

High Burden of Mental Health Problems, Substance Use, Violence, and Related Psychosocial Factors in Transgender, Non-Binary, and Gender Diverse Youth and Young Adults. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Mental health disorders in young urban sexual minority men. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

How is everyone doing? Baseline psychological distress and adaptive functioning among transgender, nonbinary, and cis youth presenting for intensive outpatient psychiatric services. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

The Development of Proud & Empowered: An Intervention for Promoting LGBTQ Adolescent Mental Health. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Depression, Anxiety, and Interest in Mental Health Resources in School-Based Gender-Sexuality Alliances: Implications for Sexual and Gender Minority Youth Health Promotion. [2022]