AFFIRM for Mental Health Issue

Phase-Based Progress Estimates
Mental Health Issue+3 MoreAFFIRM - Behavioral
14 - 29
All Sexes
What conditions do you have?

Study Summary

This trial is testing a 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among sexual and gender minority youth. The intervention is delivered by two facilitators (primarily social workers and peers) in a manner that affirms participants' sexual and gender minority identities and experiences. All participants receive the intervention in clusters over the course of the five-year trial.

Eligible Conditions
  • Mental Health Issue
  • HIV (Human Immunodeficiency Virus)
  • Social Stigma
  • Coping Skills

Treatment Effectiveness

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

Week 56
Abstinence Self-Efficacy Scale
Change in Adult Hope Scale
Change in Beck Depression Inventory-II
Change in Brief COPE Scale
Change in Current Mood Scale
Change in DSM 5a Self-Rated Level 1 Cross-Cutting Symptom Measure - Child
Change in Everyday Discrimination Scale
Change in Internalized Homophobia Scale
Change in LGBTQ Microaggressions Scale
Change in Proactive Coping Inventory for Adolescents-A - Reflective Coping Subscale
Change in Sexual Health Capacity Scale
Change in Stress Appraisal Measure for Adolescents
Protection Self-Efficacy Scale
Week 1
Intervention fidelity - how closely facilitators adhere to intervention model
week 56
Acceptability - participant satisfaction with group sessions
Feasibility - participant attendance at group sessions

Trial Safety

Trial Design

2 Treatment Groups

Waitlisted control
1 of 2
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: AFFIRM · No Placebo Group · N/A

Experimental Group · 1 Intervention: AFFIRM · Intervention Types: Behavioral
Waitlisted controlNoIntervention Group · 1 Intervention: Waitlisted control · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

Who is running the clinical trial?

University of TorontoLead Sponsor
634 Previous Clinical Trials
721,544 Total Patients Enrolled
Shelley L Craig, PhDPrincipal InvestigatorProfessor

Eligibility Criteria

Age 14 - 29 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
The text is saying that the people who will be screened are those who are between the ages of 14 and 29.
Someone who identifies as a sexual and/or gender minority identifies as something other than heterosexual and/or cisgender
Can understand and communicate in Spanish I can speak, read, and write in both Spanish and English fluently
I would like to participate in the 8-session AFFIRM intervention.