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Coping Skills Intervention for Mental Health in Sexual and Gender Minority Youth (AFFIRM Trial)

N/A
Waitlist Available
Led By Shelley L Craig, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 14 to 29 years at time of screening
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
As AFFIRM is a coping skills educational intervention rather than a medical treatment, it does not have physical side effects like drugs do. However, discussing sensitive topics might cause emotional discomfort.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 14 and 29 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability - participant satisfaction with group sessions
Feasibility - participant attendance at group sessions
Secondary study objectives
Intervention fidelity - how closely facilitators adhere to intervention model
Other study objectives
Abstinence Self-Efficacy Scale
Change in Adult Hope Scale
Change in Beck Depression Inventory-II
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: AFFIRMExperimental Treatment1 Intervention
AFFIRM is an 8-session psychoeducational weekly group intervention
Group II: Waitlisted controlActive Control1 Intervention
Waitlisted control

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Coping skills interventions, such as the AFFIRM program, work by teaching patients practical skills to manage their emotions and behaviors through education and rehearsal. These treatments involve cognitive restructuring to change negative thought patterns and behavioral rehearsal to practice new skills in a supportive environment. This approach is crucial for mental health patients as it equips them with effective tools to handle stressors, thereby reducing psychosocial distress and enhancing overall well-being.
A Brief Mindfulness-Based Cognitive Therapy (MBCT) Intervention as a Population-Level Strategy for Anxiety and Depression.Solution Focused Brief Therapy Telemental Health Suicide Intervention.Psychotherapy for Borderline Personality Disorder: Progress and Remaining Challenges.

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor
713 Previous Clinical Trials
1,022,022 Total Patients Enrolled
1 Trials studying Mental Health Issue
93 Patients Enrolled for Mental Health Issue
Shelley L Craig, PhDPrincipal InvestigatorProfessor

Media Library

AFFIRM Clinical Trial Eligibility Overview. Trial Name: NCT04318769 — N/A
Mental Health Issue Research Study Groups: AFFIRM, Waitlisted control
Mental Health Issue Clinical Trial 2023: AFFIRM Highlights & Side Effects. Trial Name: NCT04318769 — N/A
AFFIRM 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318769 — N/A
~35 spots leftby Nov 2025