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

Study Overview
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Brief Summary
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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
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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

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

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

Intervention / Treatment
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* Behavioral: AFFIRM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AFFIRM<br>AFFIRM is an 8-session psychoeducational weekly group intervention | Behavioral: AFFIRM<br>* 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.<br>|
| No Intervention: Waitlisted control<br>Waitlisted control | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility - participant attendance at group sessions | Proportions of participants that enroll, commence, and complete the intervention. | week 56 | 
| Acceptability - participant satisfaction with group sessions | Participants will complete a satisfaction questionnaire. | week 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention fidelity - how closely facilitators adhere to intervention model | 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 | Study period sessions 1-8 (weeks 1-8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual and gender minority youth, Cognitive behavioral therapy