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Clinical Trials/NCT06587139
NCT06587139
Completed
Not Applicable

An Online Mentoring Program to Prevent Adversities Among Trans and Other Gender Minority Youth (PILOT RCT PHASE)

University of Michigan1 site in 1 country56 target enrollmentJuly 22, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Recreational Drug Use
Sponsor
University of Michigan
Enrollment
56
Locations
1
Primary Endpoint
Alcohol Use (Youth-reported)
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentor, based on their shared interests. Mentors and mentees will participate together in each session along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions.

Detailed Description

Transgender and/or gender minority youth (TGMY) (i.e., any identity other than cisgender) experience concerning rates of mental health problems, self-harm, alcohol and drug use, sexual risk-taking, and violence victimization and perpetration. Minority stress theory states that peer and family rejection and internalized transphobia predict negative health outcomes in TGMY. This highlights the urgent need to identify effective programs that prevent psychosocial and behavioral health issues among TGMY. Mentoring programs may be especially impactful for TGMY, given that these programs may help alleviate adverse outcomes associated with peer and family rejection, and promote self-acceptance among TGMY. However, few mentoring programs exist specifically for TGMY, and those that do have not been rigorously evaluated; often require guardian permission; generally occur in person via community organizations--which excludes TGMY in high stigma, rural areas of the United States from participating; and rarely include evidence-based skill-building components (e.g., social-emotional skills). The specific aims of this trial are as follow: 1. Assess acceptability and feasibility of the Teen Connection Project (TCP) through observations (to evaluate program delivery and observe mentor-mentee interactions), post-session surveys, and exit interviews with participants. 2. Generate preliminary data on the TCP's efficacy in reducing psychosocial and behavioral health issues facing TGMY, including mental health problems, self-harm, alcohol and drug use, sexual risk-taking, and teen dating violence. 3. Identify treatment options for TGMY. The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentors, based on their shared interests. Mentors and mentees will participate together in each session, along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions.

Registry
clinicaltrials.gov
Start Date
July 22, 2024
End Date
June 3, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katie M Edwards

Professor, School of Social Work Director, Interpersonal Violence Research Laboratory (IVRL)

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Alcohol Use (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Youth Risk Behavior Survey Questionnaire (YRBSS). Minimum Value = 0, Maximum Value = 6, Higher scores = worse outcomes

Drug Use (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

YRBSS. Minimum Value = 0, Maximum Value = 5, Higher scores = worse outcomes

Sexual Risk-Taking (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Researcher-created items, adapted items with input from a youth advisory board from, YRBSS, and Sexual Risk Taking Survey. Minimum Value = 1, Maximum Value = 7, Higher scores = worse outcomes

Dating and Sexual Violence (DSV) victimization-1 (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Measure of Adolescent Relationship Harassment and Abuse (MARSHA). Minimum Value = 0, Maximum Value = 3, Higher scores = worse outcomes

DSV perpetration-1 (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

MARSHA. Minimum Value = 0, Maximum Value = 3, Higher scores = worse outcomes

DSV victimization-2 (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

CTS-2: SGM-Specific Intimate partner Violence (IPV) Tactics Scale \[CTS = Conflict Tactics Scale, SGM = sexual and gender minority\]. Minimum Value = 0, Maximum value = 3, Higher scores = worse outcomes

DSV perpetration-2 (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

CTS-2: SGM-Specific IPV Tactics Scale. Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

Depressive symptoms (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Patient Health Questionnaire for Adolescents (PHQ-9). Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

Anxiety symptoms (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Generalized Anxiety Disorder Screener (GAD-7). Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

Suicidality (Youth-reported)

Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Suicidal Ideation Attributes Scale (SIDAS). Minimum Value = 0, Maximum Value = 10, Higher scores = Better outcomes

Study Sites (1)

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