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

Sponsor
University of Toronto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04318769
Collaborator
(none)
300
7
2
69
42.9
0.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: AFFIRM
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.
Masking:
Double (Care Provider, Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Supportive Care
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
Actual Study Start Date :
Apr 1, 2017
Anticipated Primary Completion Date :
Mar 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: AFFIRM

AFFIRM is an 8-session psychoeducational weekly group 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.

No Intervention: Waitlisted control

Waitlisted control

Outcome Measures

Primary Outcome Measures

  1. Feasibility - participant attendance at group sessions [week 56]

    Proportions of participants that enroll, commence, and complete the intervention.

  2. Acceptability - participant satisfaction with group sessions [week 56]

    Participants will complete a satisfaction questionnaire.

Secondary Outcome Measures

  1. Intervention fidelity - how closely facilitators adhere to intervention model [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

Other Outcome Measures

  1. 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)]

    Four items. Scores range from 4 to 16. Higher scores mean better outcomes.

  2. Abstinence Self-Efficacy Scale [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.

  3. Protection Self-Efficacy Scale [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

  4. Change in DSM 5a Self-Rated Level 1 Cross-Cutting Symptom Measure - Child [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.

  5. Change in Current Mood Scale [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.

  6. Change in Beck Depression Inventory-II [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.

  7. Change in Brief COPE Scale [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.

  8. Change in Proactive Coping Inventory for Adolescents-A - Reflective Coping Subscale [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.

  9. Change in Stress Appraisal Measure for Adolescents [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.

  10. Change in Adult Hope Scale [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.

  11. Change in Internalized Homophobia Scale [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.

  12. Change in Everyday Discrimination Scale [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.

  13. Change in LGBTQ Microaggressions Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 COMPASS Health Hamilton Ontario Canada L8L4N5
2 Hamilton Family Health Team Hamilton Ontario Canada L8R2K8
3 Reach Out Centre for Kids - Positive Space Network Oakville Ontario Canada L6H3K4
4 The 519 Church Street Community Centre Toronto Ontario Canada M4Y2C9
5 Sherbourne Health Centre Toronto Ontario Canada M5A2S5
6 Asian Community AIDS Services (ACAS) Toronto Ontario Canada M5T2E3
7 Centre for Addiction and Mental Health (CAMH) Toronto Ontario Canada M6J1H4

Sponsors and Collaborators

  • University of Toronto

Investigators

  • Principal Investigator: Shelley L Craig, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Shelley Craig, Professor, University of Toronto
ClinicalTrials.gov Identifier:
NCT04318769
Other Study ID Numbers:
  • 35229
First Posted:
Mar 24, 2020
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shelley Craig, Professor, University of Toronto

Study Results

No Results Posted as of Apr 27, 2021