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Coping Skills Intervention for Mental Health in Sexual and Gender Minority Youth (AFFIRM Trial)

N/A

Waitlist Available

Led By Shelley L Craig, PhD

Research Sponsored by University of Toronto

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged 14 to 29 years at time of screening

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

Awards & highlights

AFFIRM Trial Summary

This trial is testing a 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among sexual and gender minority youth. The intervention is delivered by two facilitators (primarily social workers and peers) in a manner that affirms participants' sexual and gender minority identities and experiences. All participants receive the intervention in clusters over the course of the five-year trial.

Who is the study for?

This trial is for young individuals aged 14 to 29 who identify as part of the sexual and/or gender minority community, can communicate fluently in English, and are interested in an intervention called AFFIRM. It's not suitable for those needing more intensive therapy or currently in crisis with a high risk of suicidality.Check my eligibility

What is being tested?

AFFIRM, an 8-session group program designed to help reduce sexual risks and mental distress by affirming sexual and gender identities through education and role-play exercises. The study spans five years using a stepped wedge design where participants receive the intervention at different times.See study design

What are the potential side effects?

As AFFIRM is a coping skills educational intervention rather than a medical treatment, it does not have physical side effects like drugs do. However, discussing sensitive topics might cause emotional discomfort.

AFFIRM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 14 and 29 years old.

AFFIRM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit (week -1), postintervention visit (week 8), 6-month follow-up (week 32), 1-year follow-up (week 56) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability - participant satisfaction with group sessions

Feasibility - participant attendance at group sessions

Secondary outcome measures

Intervention fidelity - how closely facilitators adhere to intervention model

Other outcome measures

Abstinence Self-Efficacy Scale

Change in Adult Hope Scale

Change in Beck Depression Inventory-II

+10 more

AFFIRM Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AFFIRMExperimental Treatment1 Intervention

AFFIRM is an 8-session psychoeducational weekly group intervention

Group II: Waitlisted controlActive Control1 Intervention

Waitlisted control

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of TorontoLead Sponsor

689 Previous Clinical Trials

1,018,343 Total Patients Enrolled

1 Trials studying Mental Health Issue

93 Patients Enrolled for Mental Health Issue

Shelley L Craig, PhDPrincipal InvestigatorProfessor

Media Library

AFFIRM Clinical Trial Eligibility Overview. Trial Name: NCT04318769 — N/A

Mental Health Issue Research Study Groups: AFFIRM, Waitlisted control

Mental Health Issue Clinical Trial 2023: AFFIRM Highlights & Side Effects. Trial Name: NCT04318769 — N/A

AFFIRM 2023 Treatment Timeline for Medical Study. Trial Name: NCT04318769 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the maximum age limit for this research endeavor above 25 years?

"The requirements for enrollment in this study set a 14 to 29 year age range. Separately, 49 clinical trials are available for minors under 18 and 123 more trials focus on patients above 65 years old."

Answered by AI

Are there any openings for participants in this experiment at the moment?

"According to the clinicaltrials.gov database, this medical trial is presently in search of participants. This study was initially published on April 1st 2017 and its most recent update came out October 31st 2022."

Answered by AI

What criteria must individuals meet to be eligible for participation in this trial?

"Applicants must be aged between 14 and 29, have a history of social stigma, and will join the 300 participants partaking in this trial."

Answered by AI

How many subjects are being analyzed in this trial?

"Affirmative. Records on clinicaltrials.gov indicate that this medical trial is still recruiting participants, with a start date of April 1st 2017 and the latest amendment being made October 31st 2022. The study goal is to enroll 300 patients at seven distinct sites."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

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

Craig, Shelley L, Lauren B McInroy, Andrew David Eaton, Gio Iacono, Vivian WY Leung, Ashley Austin, and Cheryl Dobinson. 2019. “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 Research Protocols. JMIR Publications Inc.. doi:10.2196/13462.

clinicaltrials.govStudy

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

Shelley Craig 2017. "An Affirmative Coping Skills Intervention to Improve Mental and Sexual Health of Sexual and Gender Minority Youth". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04318769.