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

NCT ID: NCT04318769

Last Updated: 2025-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-01

Study Completion Date

2025-12-31

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

Conditions

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Mental Health Issue Hiv Stigma, Social Coping Skills

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

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

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors
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

Study Groups

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AFFIRM

AFFIRM is an 8-session psychoeducational weekly group intervention

Group Type EXPERIMENTAL

AFFIRM

Intervention Type 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.

Waitlisted control

Waitlisted control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

14 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Shelley Craig

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shelley L Craig, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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COMPASS Health

Hamilton, Ontario, Canada

Site Status

Hamilton Family Health Team

Hamilton, Ontario, Canada

Site Status

Reach Out Centre for Kids - Positive Space Network

Oakville, Ontario, Canada

Site Status

The 519 Church Street Community Centre

Toronto, Ontario, Canada

Site Status

Sherbourne Health Centre

Toronto, Ontario, Canada

Site Status

Asian Community AIDS Services (ACAS)

Toronto, Ontario, Canada

Site Status

Centre for Addiction and Mental Health (CAMH)

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type BACKGROUND
PMID: 31172957 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40922004 (View on PubMed)

Related Links

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Other Identifiers

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35229

Identifier Type: -

Identifier Source: org_study_id

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