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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hiv; Coping Skills; Mental Health Issue; Stigma, Social
• Intervention / Treatment: Behavioral: AFFIRM

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

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew D Eaton, MSW; Phone Number: 4169788895; Email: andrew.eaton@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L4N5
      • COMPASS Health
    • Hamilton, Ontario, Canada, L8R2K8
      • Hamilton Family Health Team
    • Oakville, Ontario, Canada, L6H3K4
      • Reach Out Centre for Kids - Positive Space Network
    • Toronto, Ontario, Canada, M6J1H4
      • Centre for Addiction and Mental Health (CAMH)
    • Toronto, Ontario, Canada, M4Y2C9
      • The 519 Church Street Community Centre
    • Toronto, Ontario, Canada, M5A2S5
      • Sherbourne Health Centre
    • Toronto, Ontario, Canada, M5T2E3
      • Asian Community AIDS Services (ACAS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 27 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AFFIRM; AFFIRM is an 8-session psychoeducational weekly group intervention	Behavioral: AFFIRM; 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.
No Intervention: Waitlisted control

What is the study measuring?

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)

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Toronto
• Investigators: Principal Investigator: Shelley L Craig, PhD, Professor

Publications and helpful links

General Publications

• Craig SL, McInroy LB, Eaton AD, Iacono G, Leung VW, Austin A, Dobinson C. An Affirmative Coping Skills Intervention to Improve the Mental and Sexual Health of Sexual and Gender Minority Youth (Project Youth AFFIRM): Protocol for an Implementation Study. JMIR Res Protoc. 2019 Jun 6;8(6):e13462. doi: 10.2196/13462.

Helpful Links

• Project Website

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Sexual and gender minority youth
• Other Study ID Numbers: 35229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No