Clinical trial NCT06587139: Evaluation of Teen Connection Project for Trans and Gender Minority Youth
Official title: An Online Mentoring Program to Prevent Adversities Among Trans and Other Gender Minority Youth (PILOT RCT PHASE)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: 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
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
First posted: 2024-09-19
Enrollment: 54
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Alcohol Use (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Drug Use (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Sexual Risk-Taking (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Dating and Sexual Violence (DSV) victimization-1 (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: DSV perpetration-1 (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: DSV victimization-2 (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: DSV perpetration-2 (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Depressive symptoms (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Anxiety symptoms (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Suicidality (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
Secondary outcomes:
Other outcomes:
measure: Social-Emotional Competence (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Gender Minority Stress (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Outness (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Positive Identity (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Hope for the Future (Youth-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)
measure: Mentor Process Scale (Adult-reported)
timeFrame: Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention)
measure: Reflection and Evaluation (Adult-reported)
timeFrame: Time 2 (immediately post-intervention)
Locations:
city: Lincoln
country: United States
facility: [online program, administered by the University of Nebraska-Lincoln]
state: Nebraska
Study officials:
affiliation: University of Nebraska Lincoln
name: Katie M Edwards, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: CDC (2023). Youth Risk Behavior Survey. Centers for Disease Control and Prevention. https://www.cdc.gov/healthyyouth/data/yrbs/index.htm
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: University of Connecticut and the Human Rights Campaign. 2022 National Survey on LGBTQ Youth Mental Health. https://www.thetrevorproject.org/survey-2022/
citation: 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.
citation: 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.
citation: 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.