Mental Health IssueAFFIRMNCT04318769
An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth
A study testing AFFIRM in people with Mental Health Issue and Hiv, run by University of Toronto at 7 sites in Canada.
Trial 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)… Read more about this study
- Who is it for?
- Ages 14 to 29 years
- Conditions the study is for
- Mental Health Issue, Hiv, Stigma, Social
- What is being tested?
- AFFIRM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 7 sitesCanada
- Study dates
- 1 Apr 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Assessed to be in crisis (i.e., high risk of suicidality)
- Warrenting a more intensive intervention
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
COMPASS Health
Hamilton, Ontario, L8L4N5
Hamilton Family Health Team
Hamilton, Ontario, L8R2K8
Reach Out Centre for Kids - Positive Space Network
Oakville, Ontario, L6H3K4
The 519 Church Street Community Centre
Toronto, Ontario, M4Y2C9
Sherbourne Health Centre
Toronto, Ontario, M5A2S5
Asian Community AIDS Services (ACAS)
Toronto, Ontario, M5T2E3
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, M6J1H4
About this study
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
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.
Read the 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
- Conditions
- Mental Health Issue, Hiv, Stigma, Social, Coping Skills
- Being tested
- AFFIRM
- Keywords
- Sexual and gender minority youth, Cognitive behavioral therapy
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Social Stigma, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFFIRMBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| AFFIRM | Experimental | AFFIRM is an 8-session psychoeducational weekly group intervention Receives: Behavioral: AFFIRM |
| Waitlisted control | No intervention | Waitlisted control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - participant attendance at group sessions
Proportions of participants that enroll, commence, and complete the intervention.
Measured: week 56
Acceptability - participant satisfaction with group sessions
Participants will complete a satisfaction questionnaire.
Measured: week 56
Secondary outcomes (1)
Intervention fidelity - how closely facilitators adhere to intervention model
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
Measured: Study period sessions 1-8 (weeks 1-8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start1 Apr 2017
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shelley Craig, University of Toronto
- Investigators
- Shelley L Craig, PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04318769
- Sponsor's protocol ID
- 35229
- Acronym
- AFFIRM
- Status last verified
- Mar 2025
- First submitted
- 18 Mar 2020
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers.
Publications
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.
PubMed 31172957Craig 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.
PubMed 40922004
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04318769
- Acronym / sponsor ID
- AFFIRM / 35229
- Conditions
- Mental Health Issue, Hiv, Stigma, Social, Coping Skills
- Keywords
- Sexual and gender minority youth, Cognitive behavioral therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are allocated in a 2:1 fashion to arm 1: AFFIRM intervention; or arm 2: waitlisted control.
| Arm | Type | Receives |
|---|---|---|
| AFFIRM | Experimental | Behavioral: AFFIRMAFFIRM is an 8-session psychoeducational weekly group intervention |
| Waitlisted control | No intervention | –Waitlisted control |
Who may qualify
- Ages
- 14 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Assessed to be in crisis (i.e., high risk of suicidality)
- Warrenting a more intensive intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFFIRMAFFIRM 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. | Behavioural | AFFIRM |
Primary outcome
Feasibility - participant attendance at group sessions
Time frame: week 56
Proportions of participants that enroll, commence, and complete the intervention.
Acceptability - participant satisfaction with group sessions
Time frame: week 56
Participants will complete a satisfaction questionnaire.
1 secondary outcome
Intervention fidelity - how closely facilitators adhere to intervention model
Time frame: Study period sessions 1-8 (weeks 1-8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 31172957Craig 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.
- Derived from this study: PubMed 40922004Craig 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.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley L Craig, PhD principal investigator
Professor
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AFFIRM in people with Mental Health Issue and Hiv, run by University of Toronto at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - participant attendance at group sessions (time frame: week 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04318769, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.