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

(AFFIRM Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a group program called AFFIRM, designed to help sexual and gender minority youth improve mental health and reduce risky behaviors. The program includes eight sessions where participants learn coping skills and practice real-life scenarios in a supportive environment. Participants must identify as a sexual or gender minority, be between 14 and 29 years old, and be interested in joining the 8-session program.

As an unphased trial, this study provides a unique opportunity to contribute to research supporting mental health in sexual and gender minority youth.

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.

What prior data suggests that this intervention is safe for sexual and gender minority youth?

Research has shown that the AFFIRM program is generally safe and well-received by participants. Studies have found that AFFIRM can reduce depression and improve mental well-being in young people who identify as sexual and gender minorities. These individuals often face challenges that can impact their mental health, and the program is designed to support them positively and affirmatively. No major reports of negative effects have emerged from participating in AFFIRM, suggesting it is a safe choice for those seeking to improve their coping skills and mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

AFFIRM is unique because it specifically targets mental health in sexual and gender minority youth through an 8-session psychoeducational group intervention. Unlike standard treatments that often focus on medication or individual therapy, AFFIRM promotes resilience and coping skills in a supportive group setting, which can be particularly empowering for young individuals facing discrimination or identity-related stress. Researchers are excited about this approach because it not only addresses mental health symptoms but also fosters community and peer support, which can lead to more sustainable, long-term benefits for participants.

What evidence suggests that the AFFIRM intervention is effective for mental health in sexual and gender minority youth?

Research has shown that the AFFIRM program, which participants in this trial may receive, effectively reduces mental health issues among LGBTQ+ youth. Studies have found that AFFIRM lowers depression and emotional distress, common challenges for these groups. Participants reported feeling less threatened or stressed in difficult situations. The program employs supportive techniques to build coping skills and affirm participants' identities. Overall, AFFIRM successfully engages young people and improves their mental health. ^{1 4 5 6 7}

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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8183324/

Efficacy of affirmative cognitive behavioural group therapy ...

As a voluntary program, AFFIRM successfully engaged both sexual and gender minority youth and young adults across a wide range of mental ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31172957/

An Affirmative Coping Skills Intervention to Improve the ...

Objective: The aim of this study is to scale-up implementation and delivery of AFFIRM, an 8-session manualized group coping skills intervention ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0190740916300561

The AFFIRM open pilot feasibility study: A brief ...

We pilot test an affirmative cognitive behavioral intervention for sexual and gender minority youth. · AFFIRM contributes to reduced depression, threat appraisal ...

4.

researchgate.net

researchgate.net/publication/352192875_Efficacy_of_affirmative_cognitive_behavioural_group_therapy_for_sexual_and_gender_minority_adolescents_and_young_adults_in_community_settings_in_Ontario_Canada

Efficacy of affirmative cognitive behavioural group therapy ...

This study tested the efficacy of AFFIRM, a brief affirmative cognitive-behavioural group intervention tailored to reduce psychosocial distress and improve ...

5.

jmir.org

jmir.org/2022/8/e39094/

An Identity-Affirming Web Application to Help Sexual and ...

This study aims to describe the results of a pilot randomized controlled trial of imi, a web application designed to improve mental health.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6592518/

An Affirmative Coping Skills Intervention to Improve the ...

Sexual and gender minority youth (SGMY, aged 14-29 years) face increased risks to their well-being, including rejection by family, exclusion from society, ...

7.

bmcpsychology.biomedcentral.com

bmcpsychology.biomedcentral.com/articles/10.1186/s40359-021-00595-6

Efficacy of affirmative cognitive behavioural group therapy for ...

As a voluntary program, AFFIRM successfully engaged both sexual and gender minority youth and young adults across a wide range of mental ...