- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06587139
Evaluation of Teen Connection Project for Trans and Gender Minority Youth (TCP)
An Online Mentoring Program to Prevent Adversities Among Trans and Other Gender Minority Youth (PILOT RCT PHASE)
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Nebraska
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Lincoln, Nebraska, United States, 68508
- [online program, administered by the University of Nebraska-Lincoln]
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for Youth:
- identify as transgender and/or gender minority youth (TGMY) (i.e., any identity other than cisgender)
- be between the ages of 14 to 18 years
- read and speak English
- live in the United States
- report consistent access to a phone, tablet, and/or computer with high-speed internet access/Wi-Fi (which represents 90+% of youth in the United States)
- report an ability to attend seven, 90-minute online sessions at pre-determined times
- pass an assent quiz
- report moderate to high levels of internalized transphobia
Exclusion Criteria for Youth:
- be at imminent risk for suicide (e.g., intent to kill themselves in the immediate future) as determined by an initial online suicide screening regarding their past month suicide risk (the Suicide Behaviors Questionnaire-Revised [SBQ-R]; modified to assess past month risk)
- demonstrate current psychosis as determined by the Prodromal Questionnaire; modified to just focus on visual and auditory symptoms
Inclusion Criteria for Mentors:
- be 30 years old or older
- identify as transgender and/or gender minority (i.e., any identity other than cisgender)
Exclusion Criteria for Mentors:
• not be currently experiencing substance use disorder or mental health challenges
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Treatment
The Teen Connection Project (TCP) is theoretically grounded, and follows best practices for effective health behavior prevention.
It includes seven 90-minute sessions with group and one-on-one mentoring components.
The intervention is facilitated by transgender and/or gender minority adults (i.e., any identity other than cisgender).
|
The Teen Connection Project (TCP) includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults.
Each transgender and/or gender minority youth (TGMY) will be paired with a TGM adult mentor based on TGMYs' rank-ordered preference for mentors.
The research team seeks to match mentors & mentees such that each TGMY is matched with one of their top 3 preferred mentors.
Mentors and mentees participate together in each session along with other mentors & mentees.
Facilitators direct activities/discussion to promote TGMY social-emotional skills acquisition and facilitate mentor-mentee conversations.
TCP sessions also include mentor-mentee breakout sessions where mentors share challenges they personally faced as TGMY and how they overcame them.
Break-out discussions focus on self-acceptance, coming out, dating questions, hopes and goals for the future, & how other marginalized social identities, such as race and ethnicity, intersect with identifying as TGMY.
Other Names:
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No Intervention: Waitlist control
Provide check-ins, provide resources, and offer program after intervention and measurement has been completed.
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No Intervention: Mentors
Mentors complete a two-day training and post-training survey, facilitate programming, and complete post-session surveys.
A subset of the mentors will complete exit interviews.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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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
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
|
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Sexual Risk-Taking (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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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
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Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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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
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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DSV perpetration-1 (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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MARSHA.
Minimum Value = 0, Maximum Value = 3, Higher scores = worse outcomes
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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DSV victimization-2 (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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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
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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DSV perpetration-2 (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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CTS-2: SGM-Specific IPV Tactics Scale.
Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Depressive symptoms (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Patient Health Questionnaire for Adolescents (PHQ-9).
Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Anxiety symptoms (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Generalized Anxiety Disorder Screener (GAD-7).
Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes
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Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Suicidality (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Suicidal Ideation Attributes Scale (SIDAS).
Minimum Value = 0, Maximum Value = 10, Higher scores = Better outcomes
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Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social-Emotional Competence (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Social-Emotional Competence Questionnaire (SEC-Q).
Minimum Value = 1, Maximum Value = 6, Higher scores = Better outcomes
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Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Gender Minority Stress (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Gender Minority Stress and Resilience Scale (adolescent extension version).
Minimum Value = 1, Maximum Value = 5, Higher scores = Worse outcomes
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
|
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Outness (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Nebraska Outness Scale, Minimum Value = 0, Maximum Value = 100, Higher scores = Better outcomes
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Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Positive Identity (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Lesbian, Gay, and Bisexual Positive Identity Measure.
Minimum Value = 1, Maximum Value = 7, Higher scores = Better outcomes
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Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Hope for the Future (Youth-reported)
Time Frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
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Feelings about being LGBTQIA2+.
Minimum Value = 1, Maximum Value = 4, Higher scores = Better outcomes
|
Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katie M Edwards, PhD, University of Michigan
Publications and helpful links
General Publications
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.
- Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.
- Rothman EF, Paruk J, Cuevas CA, Temple JR, Gonzales K. The Development of the Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Input From Black and Multiracial, Latinx, Native American, and LGBTQ+ Youth. J Interpers Violence. 2022 Mar;37(5-6):2126-2149. doi: 10.1177/0886260520936367. Epub 2020 Jul 5.
- CDC (2023). Youth Risk Behavior Survey. Centers for Disease Control and Prevention. https://www.cdc.gov/healthyyouth/data/yrbs/index.htm
- Turchik JA, Garske JP. Measurement of sexual risk taking among college students. Arch Sex Behav. 2009 Dec;38(6):936-48. doi: 10.1007/s10508-008-9388-z. Epub 2008 Jun 19.
- Rothman EF, Cuevas CA, Mumford EA, Bahrami E, Taylor BG. The Psychometric Properties of the Measure of Adolescent Relationship Harassment and Abuse (MARSHA) With a Nationally Representative Sample of U.S. Youth. J Interpers Violence. 2022 Jun;37(11-12):NP9712-NP9737. doi: 10.1177/0886260520985480. Epub 2021 Jan 5.
- Dyar C, Messinger AM, Newcomb ME, Byck GR, Dunlap P, Whitton SW. Development and Initial Validation of Three Culturally Sensitive Measures of Intimate Partner Violence for Sexual and Gender Minority Populations. J Interpers Violence. 2021 Aug;36(15-16):NP8824-NP8851. doi: 10.1177/0886260519846856. Epub 2019 May 5.
- Zhou M, Ee J. Development and validation of the Social Emotional Competence Questionnaire (SECQ). The International Journal of Emotional Education. 2012;4(2):27-42.
- Hidalgo MA, Petras H, Chen D, Chodzen G. The Gender Minority Stress and Resilience Measure: Psychometric Validity of an Adolescent Extension. Clin Pract Pediatr Psychol. 2019;7(3):278-290. doi: 10.1037/cpp0000297.
- Meidlinger, P. C., & Hope, D. A. (2014). Differentiating disclosure and concealment in measurement of outness for sexual minorities: The Nebraska Outness Scale. Psychology of Sexual Orientation and Gender Diversity, 1(4), 489.
- Riggle, E. D., Mohr, J. J., Rostosky, S. S., Fingerhut, A. W., & Balsam, K. F. (2014). A multifactor lesbian, gay, and bisexual positive identity measure (LGB-PIM). Psychology of Sexual Orientation and Gender Diversity, 1(4), 398.
- University of Connecticut and the Human Rights Campaign. 2022 National Survey on LGBTQ Youth Mental Health. https://www.thetrevorproject.org/survey-2022/
- Turchik JA, Garske JP. Sexual risk survey. In: Fisher TD, Davis CM, Yarber WL, Davis SL, eds. Handbook of sexuality-related measures. 3rd ed. Routledge; 2010:600-602.
- Tolan PH, McDaniel HL, Richardson M, Arkin N, Augenstern J, DuBois DL. Improving understanding of how mentoring works: Measuring multiple intervention processes. J Community Psychol. 2020 Aug;48(6):2086-2107. doi: 10.1002/jcop.22408. Epub 2020 Jul 11.
- Keller TE, Drew AL, Herrera C, Clark-Shim H, Spencer R. Do program practices matter for mentors?: How implementation of empirically supported program practices is associated with youth mentoring relationship quality. J Community Psychol. 2023 Nov;51(8):3194-3215. doi: 10.1002/jcop.23019. Epub 2023 Feb 25.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23676
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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