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Recreational Drug UseTCPNCT06587139

Evaluation of Teen Connection Project for Trans and Gender Minority Youth

A study testing Teen Connection Project (TCP) in people with Recreational Drug Use and Sexual Violence, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 14 years and olderHealthy volunteers can take part
What is being tested?
Teen Connection Project (TCP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
22 Jul 2024to 3 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • pass an assent quiz
  • report moderate to high levels of internalized transphobia
  • be 30 years old or older
  • identify as transgender and/or gender minority (i.e., any identity other than cisgender)

Who cannot join

  • 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
  • not be currently experiencing substance use disorder or mental health challenges

Trial locations and contacts

1 site in 1 country.

United States1 site
  • [online program, administered by the University of Nebraska-Lincoln]

    Lincoln, Nebraska, 68508

Other trials in United States

About this study

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

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.

Being tested
Teen Connection Project (TCP)
Keywords
Risk-Taking, Sexual Behavior, Sex Offenses, Intimate Partner Violence, Crime Victims
Medical subject headings
Recreational Drug Use, Depression, Anxiety Disorders, Suicidal Ideation, Risk-Taking, Alcohol Drinking, Sexual Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teen Connection Project (TCP)Behavioural

    Also called 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.

Study groups in NCT06587139
Study groupRoleWhat they receive
TreatmentExperimentalThe 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).
Receives: Behavioral: Teen Connection Project (TCP)
Waitlist controlNo interventionProvide check-ins, provide resources, and offer program after intervention and measurement has been completed.
MentorsNo interventionMentors 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Alcohol Use (Youth-reported)

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start22 Jul 2024
  3. Primary completion3 Jun 2025
  4. Study completion3 Jun 2025

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
transgender and/or gender minority youth (TGMY) (n=80) are randomly assigned to a treatment (n=40) or wait-list (n=40) control condition.
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06587139
Sponsor's protocol ID
23676
Acronym
TCP
Status last verified
May 2026
First submitted
9 Aug 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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).

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

Questions about this trial

What is this clinical trial studying?

A study testing Teen Connection Project (TCP) in people with Recreational Drug Use and Sexual Violence, run by University of Michigan at 1 site in United States.

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 10 inclusion and 3 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Alcohol Use (Youth-reported) (time frame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)). The study lists 10 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 NCT06587139, which also lists 16 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 22 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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