NCT Number: NCT04318769
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.
This study is active but is not currently recruiting participants.
Notify Me14 year–29 year
All sexes
Interventional
Not applicable
COMPASS Health, Hamilton, Ontario, Canada
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: week 56
Proportions of participants that enroll, commence, and complete the intervention.
Time frame: week 56
Participants will complete a satisfaction questionnaire.
Time frame: Study period sessions 1-8 (weeks 1-8)
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
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Four items. Scores range from 4 to 16. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Five items. Scores range from 5 to 20. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Eight items. Scores range from 8 to 32. Higher scores mean better outcomes
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Twenty items. Scores range from 0 to 80. Lower scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Six items. Scores range from 0 to 60. Lower scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
Twenty items. Scores range from 0 to 80. Lower scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
28 items. Scores range from 28 to 112. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
11 items. Scores range from 0 to 33. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
13 items. Scores range from 13 to 65. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
12 items. Scores range from 12 to 96. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
10 items. Score range from 10 to 100. Lower scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
7 items. Scores range from 7 to 42. Higher scores mean better outcomes.
Time frame: Baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)
15 items. Scores from 0 to 75. Lower scores mean better outcomes.
University of Toronto
Other
An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth (AFFIRM): A Stepped Wedge Waitlist Crossover Trial
Acronym: AFFIRM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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