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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318769
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Shelley Craig, University of Toronto

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
Mental Health Issue Hiv Stigma, Social Coping Skills Behavioral: AFFIRM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : April 1, 2017
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Feasibility - participant attendance at group sessions [ Time Frame: week 56 ]
    Proportions of participants that enroll, commence, and complete the intervention.

  2. Acceptability - participant satisfaction with group sessions [ Time Frame: week 56 ]
    Participants will complete a satisfaction questionnaire.


Secondary Outcome Measures :
  1. Intervention fidelity - how closely facilitators adhere to intervention model [ 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


Other Outcome Measures:
  1. Change in Sexual Health Capacity Scale [ 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.

  2. Abstinence Self-Efficacy Scale [ 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.

  3. Protection Self-Efficacy Scale [ 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

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

  5. Change in Current Mood Scale [ 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.

  6. Change in Beck Depression Inventory-II [ 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.

  7. Change in Brief COPE Scale [ 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.

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

  9. Change in Stress Appraisal Measure for Adolescents [ 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.

  10. Change in Adult Hope Scale [ 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.

  11. Change in Internalized Homophobia Scale [ 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.

  12. Change in Everyday Discrimination Scale [ 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.

  13. Change in LGBTQ Microaggressions Scale [ 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Participants must self-identify as a sexual minority and/or as a gender minority
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318769


Contacts
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Contact: Andrew D Eaton, MSW 4169788895 andrew.eaton@utoronto.ca

Locations
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Canada, Ontario
COMPASS Health Recruiting
Hamilton, Ontario, Canada, L8L4N5
Contact: Diana DeSimone         
Hamilton Family Health Team Recruiting
Hamilton, Ontario, Canada, L8R2K8
Contact: Tim Elliott         
Reach Out Centre for Kids - Positive Space Network Recruiting
Oakville, Ontario, Canada, L6H3K4
Contact: Shaiden Keaney, MSW         
The 519 Church Street Community Centre Recruiting
Toronto, Ontario, Canada, M4Y2C9
Contact: Cressida Frey, MSW         
Sherbourne Health Centre Recruiting
Toronto, Ontario, Canada, M5A2S5
Contact: Patrick Salvani         
Asian Community AIDS Services (ACAS) Recruiting
Toronto, Ontario, Canada, M5T2E3
Contact: Ryan Tran         
Centre for Addiction and Mental Health (CAMH) Recruiting
Toronto, Ontario, Canada, M6J1H4
Contact: Christina Yager, MSW         
Sponsors and Collaborators
University of Toronto
Investigators
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Principal Investigator: Shelley L Craig, PhD Professor
Additional Information:
Publications:
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Responsible Party: Shelley Craig, Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT04318769    
Other Study ID Numbers: 35229
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shelley Craig, University of Toronto:
Sexual and gender minority youth
Cognitive behavioral therapy