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

NCT04318769 | Active Not Recruiting

• 1 other identifier: 35229
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Sexual and gender minority youth; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Intervention fidelity - how closely facilitators adhere to intervention model

  Study period sessions 1-8 (weeks 1-8)

Other Outcomes (13)

• Change in Sexual Health Capacity Scale

  Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

• Abstinence Self-Efficacy Scale

  Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

• Protection Self-Efficacy Scale

  Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

Study Arms (2)

AFFIRM

EXPERIMENTAL

AFFIRM is an 8-session psychoeducational weekly group intervention

Behavioral: AFFIRM

Waitlisted control

NO INTERVENTION

Waitlisted control

Interventions

AFFIRM BEHAVIORAL

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

Eligibility Criteria

• Age: 14 Years - 29 Years
• Gender Eligibility Details: Participants must self-identify as a sexual minority and/or as a gender minority
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Toronto: lead

Study Sites (7)

COMPASS Health

Hamilton, Ontario, L8L4N5, Canada

Location

Hamilton Family Health Team

Hamilton, Ontario, L8R2K8, Canada

Location

Reach Out Centre for Kids - Positive Space Network

Oakville, Ontario, L6H3K4, Canada

Location

The 519 Church Street Community Centre

Toronto, Ontario, M4Y2C9, Canada

Location

Sherbourne Health Centre

Toronto, Ontario, M5A2S5, Canada

Location

Asian Community AIDS Services (ACAS)

Toronto, Ontario, M5T2E3, Canada

Location

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (2)

• 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.

  PMID: 31172957 BACKGROUND

• Craig SL, Leung VWY, Hui JA, Iacono G, Pascoe RV, Dillon F, Austin A, Pang N, Dobinson C, Brooks AS. LGBTQ + Affirmative CBT: a hierarchical linear model of longitudinal outcomes and mechanisms of change. BMC Psychol. 2025 Sep 8;13(1):1006. doi: 10.1186/s40359-025-03314-7.

  PMID: 40922004 DERIVED

Related Links

• Project Website

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Social Stigma; Coitus

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Social Behavior; Behavior; Sexual Behavior

Study Officials

• Shelley L Craig, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: March 18, 2020
• First Posted: March 24, 2020
• Study Start: April 1, 2017
• Primary Completion: March 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)