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

Hiv Clinical Trial

— AFFIRM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04318769
• Other study ID #: 35229
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

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

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.

Locations

Country	Name	City	State
Canada	COMPASS Health	Hamilton	Ontario
Canada	Hamilton Family Health Team	Hamilton	Ontario
Canada	Reach Out Centre for Kids - Positive Space Network	Oakville	Ontario
Canada	Asian Community AIDS Services (ACAS)	Toronto	Ontario
Canada	Centre for Addiction and Mental Health (CAMH)	Toronto	Ontario
Canada	Sherbourne Health Centre	Toronto	Ontario
Canada	The 519 Church Street Community Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	Feasibility - participant attendance at group sessions	Proportions of participants that enroll, commence, and complete the intervention.	week 56
Primary	Acceptability - participant satisfaction with group sessions	Participants will complete a satisfaction questionnaire.	week 56
Secondary	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)

External Links

•   Project Website