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An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth

An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth (AFFIRM): A Stepped Wedge Waitlist Crossover Trial

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04318769
Acronym
AFFIRM
Enrollment
300
Registered
2020-03-24
Start date
2017-04-01
Completion date
2025-12-31
Last updated
2025-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coping Skills, Hiv, Mental Health Issue, Stigma, Social

Keywords

Sexual and gender minority youth, Cognitive behavioral therapy

Brief summary

AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY. AFFIRM is delivered by two facilitators (primarily social workers and peers) through a combination of education and rehearsal (i.e., simulation of real-life experiences) in a manner that affirms participants' sexual and gender minority identities and experiences. AFFIRM is being tested in a five-year trial using a stepped wedge waitlist crossover design, where all participants receive the intervention in clusters.

Detailed description

Session 1 focus Introduction to cognitive behavioral therapy (CBT), exploring lesbian, gay, bisexual, transgender, and queer (LGBTQ)+ identities, and understanding minority stress. Session 1 activities Introductions Discussing the theory and purpose of CBT approaches Exploring stress and minority stress Understanding the causes of stress in our lives Session 2 focus Understanding the impact of anti-LGBTQ attitudes and behaviors on stress. Session 2 activities Check in and review Examining homophobia, heterosexism, and transphobia at the individual, institutional, and cultural level Identifying how these experiences impact thoughts, feelings, and behaviors Fostering strategies for both coping with and combating anti-LGBTQ discrimination at all levels Session 3 focus Understanding how thoughts impact feelings. Session 3 activities Check in and review Distinguishing between thoughts and feelings Exploring how thoughts influence feelings and behaviors Identifying counterproductive thinking patterns Recognizing negative self-talk and feelings of hopelessness Learning thought stopping Session 4 focus Using thoughts to change feelings. Session 4 activities Check in and review Increasing positive thinking and feelings of hope Changing negative thoughts to positive thoughts Challenging negative thinking and internalized homophobia/negative feelings through the ABCD (activating event, belief, consequence, and debate) method Session 5 focus Exploring how activities impact feelings. Session 5 activities Check in and review Examining the impact of various activities on feelings Identifying supportive and identity-affirming activities The impact of LGBTQ-affirming activities on feelings Session 6 focus Planning to overcome counterproductive thoughts and negative feelings. Session 6 activities Check in and review Distinguishing between clear and unclear goals Identifying short, mid-, and long-term goals Creating a sexual health plan Fostering hope for the future Session 7 focus Understanding the impact of minority stress and anti-LGBTQ attitudes or behaviors on social relationships. Session 7 activities Check in and review Anti-LGBTQ discrimination can lead to feelings of discomfort around others Responding to discrimination or harassment in social situations Learning to be assertive Session 8 focus Putting it all together: developing safe, supportive, and identity-affirming social networks. Session 8 activities Check in and review Maintaining a healthy social network: attending to thoughts, expectations, feelings, and behaviors within relationships Identifying a plan for building a supportive network

Interventions

BEHAVIORALAFFIRM

AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY. AFFIRM is delivered by two facilitators (primarily social workers and peers) through a combination of education and rehearsal (i.e., simulation of real-life experiences) in a manner that affirms participants' sexual and gender minority identities and experiences.

Sponsors

University of Toronto
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)

Masking description

Participants are not blinded as they know which arm they are allocated too. Care providers and outcome assessors are blinded as the investigator runs the allocation sequence and outcomes are administered via survey weblink

Intervention model description

Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.

Eligibility

Sex/Gender
ALL
Age
14 Years to 29 Years
Healthy volunteers
No

Inclusion criteria

* Aged 14 to 29 years at time of screening * Identifies as a sexual and/or gender minority * Reads, writes, and speaks fluent English * Is interested in participating in the 8-session AFFIRM intervention

Exclusion criteria

* Assessed to be in crisis (i.e., high risk of suicidality) * Warrenting a more intensive intervention

Design outcomes

Primary

MeasureTime frameDescription
Feasibility - participant attendance at group sessionsweek 56Proportions of participants that enroll, commence, and complete the intervention.
Acceptability - participant satisfaction with group sessionsweek 56Participants will complete a satisfaction questionnaire.

Secondary

MeasureTime frameDescription
Intervention fidelity - how closely facilitators adhere to intervention modelStudy period sessions 1-8 (weeks 1-8)Independent coders will complete a checklist questionnaire of AFFIRM intervention items, based on the manual, to determine how closely intervention facilitators adhered to the model

Other

MeasureTime frameDescription
Change in DSM 5a Self-Rated Level 1 Cross-Cutting Symptom Measure - ChildBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)Twenty items. Scores range from 0 to 80. Lower scores mean better outcomes.
Change in Current Mood ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)Six items. Scores range from 0 to 60. Lower scores mean better outcomes.
Change in Beck Depression Inventory-IIBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)Twenty items. Scores range from 0 to 80. Lower scores mean better outcomes.
Change in Brief COPE ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)28 items. Scores range from 28 to 112. Higher scores mean better outcomes.
Change in Proactive Coping Inventory for Adolescents-A - Reflective Coping SubscaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)11 items. Scores range from 0 to 33. Higher scores mean better outcomes.
Change in Sexual Health Capacity ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)Four items. Scores range from 4 to 16. Higher scores mean better outcomes.
Change in Adult Hope ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)12 items. Scores range from 12 to 96. Higher scores mean better outcomes.
Change in Internalized Homophobia ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)10 items. Score range from 10 to 100. Lower scores mean better outcomes.
Change in Everyday Discrimination ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)7 items. Scores range from 7 to 42. Higher scores mean better outcomes.
Change in LGBTQ Microaggressions ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)15 items. Scores from 0 to 75. Lower scores mean better outcomes.
Change in Stress Appraisal Measure for AdolescentsBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)13 items. Scores range from 13 to 65. Higher scores mean better outcomes.
Abstinence Self-Efficacy ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)Five items. Scores range from 5 to 20. Higher scores mean better outcomes.
Protection Self-Efficacy ScaleBaseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)Eight items. Scores range from 8 to 32. Higher scores mean better outcomes

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026