Clinical trial NCT04318769: An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Hiv
Stigma, Social
Coping Skills
Keywords: Sexual and gender minority youth
Cognitive behavioral therapy
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2020-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.
Primary purpose: SUPPORTIVE_CARE

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - participant attendance at group sessions
timeFrame: week 56
measure: Acceptability - participant satisfaction with group sessions
timeFrame: week 56
Secondary outcomes:
measure: Intervention fidelity - how closely facilitators adhere to intervention model
timeFrame: Study period sessions 1-8 (weeks 1-8)
Other outcomes:
measure: Change in Sexual Health Capacity Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Abstinence Self-Efficacy Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Protection Self-Efficacy Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in DSM 5a Self-Rated Level 1 Cross-Cutting Symptom Measure - Child
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Current Mood Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Beck Depression Inventory-II
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Brief COPE Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Proactive Coping Inventory for Adolescents-A - Reflective Coping Subscale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Stress Appraisal Measure for Adolescents
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Adult Hope Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Internalized Homophobia Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in Everyday Discrimination Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
measure: Change in LGBTQ Microaggressions Scale
timeFrame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Locations:
city: Hamilton
country: Canada
facility: COMPASS Health
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Family Health Team
state: Ontario
city: Oakville
country: Canada
facility: Reach Out Centre for Kids - Positive Space Network
state: Ontario
city: Toronto
country: Canada
facility: The 519 Church Street Community Centre
state: Ontario
city: Toronto
country: Canada
facility: Sherbourne Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Asian Community AIDS Services (ACAS)
state: Ontario
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health (CAMH)
state: Ontario
Study officials:
affiliation: Professor
name: Shelley L Craig, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.