ClinicalTrials.gg
CompletedNCT06587139TCPUpdated May 22, 2026

Evaluation of Teen Connection Project for Trans and Gender Minority Youth

An interventional study of Teen Connection Project (TCP) in Recreational Drug Use, Sexual Violence and Victimisation, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by University of Michigan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Recreational Drug Use
  • Sexual Violence
  • Victimisation
  • Depressive Symptoms
  • Anxiety
  • Suicidal Ideation
  • Risk-Taking
  • Alcohol Drinking

Keywords

  • Risk-Taking
  • Sexual Behavior
  • Sex Offenses
  • Intimate Partner Violence
  • Crime Victims
03

In context

Depression

8,577 studies on the registry are indexed under Depression; 1,720 are open to participants now.

This study's enrollment of 56 is below the median of 81 across 7,063 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.

Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
56 participants (actual)

Study arms

  • 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).

    Behavioral: Teen Connection Project (TCP)

  • No intervention
    Waitlist control

    Provide check-ins, provide resources, and offer program after intervention and measurement has been completed.

  • 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.

Interventions

  • BehavioralTeen Connection Project (TCP)

    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.

    Also known as: TCP

06

What researchers measure

Primary outcomes

  1. Alcohol Use (Youth-reported)

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

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

  2. Drug Use (Youth-reported)

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

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

  3. Sexual Risk-Taking (Youth-reported)

    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

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

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

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

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

  5. DSV perpetration-1 (Youth-reported)

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

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

  6. DSV victimization-2 (Youth-reported)

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

  7. DSV perpetration-2 (Youth-reported)

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

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

  8. Depressive symptoms (Youth-reported)

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

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

  9. Anxiety symptoms (Youth-reported)

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

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

  10. Suicidality (Youth-reported)

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

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

Other outcomes

  1. Social-Emotional Competence (Youth-reported)

    Social-Emotional Competence Questionnaire (SEC-Q). Minimum Value = 1, Maximum Value = 6, Higher scores = Better outcomes

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

  2. Gender Minority Stress (Youth-reported)

    Gender Minority Stress and Resilience Scale (adolescent extension version). Minimum Value = 1, Maximum Value = 5, Higher scores = Worse outcomes

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

  3. Outness (Youth-reported)

    Nebraska Outness Scale, Minimum Value = 0, Maximum Value = 100, Higher scores = Better outcomes

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

  4. Positive Identity (Youth-reported)

    Lesbian, Gay, and Bisexual Positive Identity Measure. Minimum Value = 1, Maximum Value = 7, Higher scores = Better outcomes

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

  5. Hope for the Future (Youth-reported)

    Feelings about being LGBTQIA2+. Minimum Value = 1, Maximum Value = 4, Higher scores = Better outcomes

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

07

Study locations

1 site
  • [online program, administered by the University of Nebraska-Lincoln]
    Lincoln, Nebraska 68508, United States
08

References and documents

Publications

  • 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. PubMed 18563548 ↗
  • 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. PubMed 33399026 ↗
  • 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. PubMed 32627640 ↗
  • 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. PubMed 31057032 ↗
  • 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. PubMed 16717171 ↗
  • 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. PubMed 21041282 ↗
  • 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. PubMed 24612048 ↗
  • 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. PubMed 33224698 ↗
  • 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. PubMed 32652575 ↗
  • 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. PubMed 36840743 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — This data will not be shared publicly. However, the PI intends to share the aggregated, de-identified quantitative survey data if users commit to the following: (a) using the data only for research purposes and not to identify any individual participant; (b) securing the data using appropriate computer technology; and (c) destroying or returning the data after analyses are completed. If the researcher agrees, in writing, to these stipulations, the PI will send them (via a link to a secure UNL OneDrive folder) the dataset prepared using SPSS (latest version available).

Supporting information: Study protocol, Statistical analysis plan, Analytic code

Time frame: Data will become available in December of 2025. It will be available for 7 years until December of 2032.

Access criteria: The PI intends to share the aggregated, de-identified quantitative survey data if users commit to the following: (a) using the data only for research purposes and not to identify any individual participant; (b) securing the data using appropriate computer technology; and (c) destroying or returning the data after analyses are completed. If the researcher agrees, in writing, to these stipulations, the PI will send him/her the dataset prepared using SPSS 24.0 (or the latest version available). The prepared data set will not include identifying information from any participant. The master list will be destroyed as soon as participants' data are linked across time. Research participants will be identified by number. A detailed codebook will be prepared and supplied with the data indicating information about each variable as well as how composite scale scores are calculated. The syntax for any data imputations will also be provided.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06587139
Collaborators
University of Rhode Island
Responsible party
Katie M Edwards (Professor, School of Social Work Director, Interpersonal Violence Research Laboratory (IVRL), University of Michigan) — Principal investigator
First posted
Sep 19, 2024
Start date
Jul 22, 2024
Primary completion
Jun 3, 2025
Completion
Jun 3, 2025
Last update
May 22, 2026

Study contacts

Katie M Edwards, PhD
principal investigator · University of Michigan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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