Mentoring Program for Transgender Youth

(TCP Trial)

Overseen By Joseph H Gardella, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska Lincoln

Disqualifiers: Suicide risk, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to create and test an online mentoring program, the Teen Connection Project (TCP), to support transgender and gender minority youth. The program includes seven sessions where participants work with mentors to develop social and emotional skills. Individuals who identify as transgender or gender minority, are between 14 and 18, and can attend online sessions may be a good fit. The study will compare participants in the program with others who receive check-ins and resources. As an unphased trial, this study provides a unique opportunity to contribute to innovative support strategies for youth.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mentoring program is safe for transgender and/or gender minority youth?

Research has shown that the Teen Connection Project (TCP) is a safe program for transgender and gender minority youth. Studies over the past 20 years have found that participants appreciate the program and it carries no known risks. Feedback from similar programs indicates that it is not only safe but also beneficial. Participants have reported positive changes in their social and emotional well-being. No major negative effects have been directly linked to the program. This makes TCP a promising choice for those seeking to enhance their social and emotional skills in a supportive setting. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Teen Connection Project (TCP) because it offers a unique, supportive approach tailored specifically for transgender youth. Unlike most standard mental health treatments that might not address the specific needs of transgender individuals, TCP incorporates group and one-on-one mentoring led by transgender or gender minority adults. This mentorship not only provides relatable role models but also fosters a supportive community, potentially leading to improved mental health outcomes. By using a structured yet personal approach, TCP could fill a crucial gap in care for transgender youth, promoting both mental and emotional well-being.

What evidence suggests that the Teen Connection Project (TCP) is effective for transgender and/or gender minority youth?

Research has shown that mentoring programs like the Teen Connection Project (TCP), which participants in this trial may receive, can improve the mental health and social skills of transgender and gender minority youth. Studies have found that mentors with similar life experiences can help young people feel less isolated and more confident. Early results suggest that programs focusing on skill-building and emotional management help participants handle stress better and enhance their overall well-being. The TCP aims to create a supportive space where young people can connect with mentors and peers, fostering a sense of belonging. Overall, mentoring programs like TCP have shown promising results in supporting the mental health of transgender and gender minority youth. ^{1 6 7 8 9}

Who Is on the Research Team?

Katie Edwards, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for transgender and/or gender minority youth aged 14 to 18 who may be experiencing anxiety, depression, suicidal thoughts, or engaging in risky behaviors like drug use or alcohol consumption. Participants should not have any conditions that would exclude them from safely participating in an online mentoring program.

Inclusion Criteria

I am at least 30 years old.

Youth must report consistent access to a phone, tablet, and/or computer with high-speed internet access/Wi-Fi

I can attend seven 90-minute online sessions as scheduled.

Exclusion Criteria

Youth must not be at imminent risk for suicide

Youth must not demonstrate current psychosis

Mentors must not be currently experiencing substance use disorder or mental health challenges

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Teen Connection Project (TCP), which includes seven 90-minute online mentoring and skill-building sessions facilitated by transgender and/or gender minority adults.

7 weeks

7 online sessions

Follow-up

Participants are monitored for psychosocial and behavioral health outcomes, including mental health, self-harm, and substance use.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Teen Connection Project (TCP)

Trial Overview The Teen Connection Project (TCP) is being tested. It's a series of seven online sessions lasting 90 minutes each where transgender and/or gender minority youth are paired with adult mentors for skill-building activities aimed at improving social-emotional skills.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

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).

Group II: Waitlist control Active Control 1 Intervention

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

Group III: Mentors Active Control 1 Intervention

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.

Teen Connection Project (TCP) is already approved in United States for the following indications:

Approved in United States as Teen Connection Project for:

• Prevention of psychosocial and behavioral health issues among transgender and other gender minority youth

Who Is Running the Clinical Trial?

University of Nebraska Lincoln

Lead Sponsor

Trials

40

Recruited

13,200+

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

University of Rhode Island

Collaborator

Trials

57

Recruited

22,400+

Published Research Related to This Trial

The Gender Wellness Center Pediatric Patient Registry has enrolled 139 transgender and gender expansive youth, primarily aged 17.5 years, to systematically study the health outcomes of gender-affirming therapy.

The majority of participants (89.1%) are undergoing medical transition, indicating a significant engagement with gender-affirming care, which will help inform evidence-based guidelines for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building a Pediatric Patient Registry to Study Health Outcomes Among Transgender and Gender Expansive Youth at a Rural Gender Clinic. O'Bryan, J., Leon, K., Wolf-Gould, C., et al.[2020]

Transgender teens (ages 13-18) and their parents showed a strong interest in support groups, with average interest ratings of 7.20/10 for teens and 7.95/10 for parents, indicating a significant desire for community support.

Both groups identified benefits such as managing school issues and accessing local resources, but noted 'no time' as the main barrier to attendance, suggesting that flexible scheduling may enhance participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating transgender youth and parent interest and preferences regarding support groups. Lawlis, SM., Butler, P., Middleman, A.[2020]

The Trans Youth Justice Project, a 6-week remote program for trans youth aged 15-22, successfully increased feelings of belonging to a trans community and developed leadership skills among participants, based on evaluations from 25 youth.

Follow-up interviews revealed that the program significantly enhanced participants' self-efficacy and skills for social justice, demonstrating its potential to empower trans youth and address social inequalities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trans Youth Justice Project: A Political Education and Leadership Development Program. Barcelos, C., McNeill, JN., Turner, Y., et al.[2023]

A study of 174 transgender youth accessing the GDAAY program in Manitoba revealed that nearly half (46.8%) had a mental health diagnosis, primarily anxiety and depression, highlighting the mental health challenges faced by this population.

Transgender youth reported negative experiences with health care providers, often due to a lack of knowledge about trans-related health services, indicating a need for improved training and resources to create supportive health care environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gender dysphoria assessment and action for youth: Review of health care services and experiences of trans youth in Manitoba. Heard, J., Morris, A., Kirouac, N., et al.[2022]

The majority of sexual and gender minority youth (SGMY) report having a mentor or role model, which is linked to positive psychosocial, behavioral, and academic outcomes.

Mentors for SGMY often possess specific characteristics that these youth seek out, but there is a need for more rigorous research to ensure safe and effective mentoring connections for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Informal and Formal Mentoring of Sexual and Gender Minority Youth: A Systematic Review. Edwards, KM., Scheer, JR., Mauer, VA.[2023]

The Transition Readiness and Assessment Questionnaire (TRAQ) was successfully piloted with 153 transgender and nonbinary youth, showing good reliability (Cronbach alpha of 0.926) in assessing their readiness for adult care.

Results indicated that while patients felt confident in communicating with providers and tracking health issues, they struggled with managing medications and keeping appointments, highlighting areas where additional support may be needed during their transition to adult care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Readiness for Transition From Pediatric to Adult Gender Affirming Care. Katz, J., Ascha, M., Merrick, E., et al.[2023]

Transgender and gender-diverse (TGD) older adults are identified as a vulnerable population with limited access to resources and heightened health risks, highlighting the need for targeted interventions.

The systematic review, which included 17 articles published between 2017 and 2022, revealed a lack of research in nursing journals, indicating a gap in nursing education and practice regarding the unique needs of TGD older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptualizing transgender and gender-diverse older adults as a vulnerable population: A systematic review. Velasco, RAF., Blakeley, A., Rostovsky, J., et al.[2023]

Trans women of color, particularly immigrant trans Latinas and trans women of African descent living with HIV, demonstrated strong social capital through 'thick trust' and 'thin trust' within their support groups, which contributed to their resilience and community leadership.

The cultivation of trust within these groups led to improved networking opportunities, educational advancements, and overall quality of life, highlighting the importance of social support in addressing the challenges faced by this marginalized population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thick trust, thin trust, social capital, and health outcomes among trans women of color in New York City. Hwahng, SJ., Allen, B., Zadoretzky, C., et al.[2022]

The Transforming Connections program, adapted from the Connect program, effectively supports parents of transgender and gender non-conforming youth, helping them understand and affirm their children's gender identity while improving parent-teen relationships.

In a group of 20 parents, participants reported feeling respected and safe, with 85% noting improvements in their relationship with their teen, highlighting the program's potential as a valuable resource for enhancing parental support and reducing stress in these families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transforming Connections: A Trauma-Informed and Attachment-Based Program to Promote Sensitive Parenting of Trans and Gender Non-conforming Youth. Dangaltcheva, A., Booth, C., Moretti, MM.[2021]

The Trans20 study is a longitudinal research project involving approximately 600 transgender and gender diverse youth, aimed at understanding their demographic and clinical characteristics, as well as the long-term outcomes of medical and psychosocial interventions.

By collecting data on gender dysphoria, mental health, and quality of life over time, the study seeks to provide evidence that will inform future treatment guidelines and improve gender-affirming healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the health outcomes of trans and gender diverse young people in Australia? Study protocol for the Trans20 longitudinal cohort study. Tollit, MA., Pace, CC., Telfer, M., et al.[2020]

Citations

1. ctv.veeva.com ctv.veeva.com/study/evaluation-of-teen-connection-project-for-trans-and-gender-minority-youth

Evaluation of Teen Connection Project for Trans and Gender ... 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) ...

2. ivrl.ssw.umich.edu ivrl.ssw.umich.edu/teen-connection-project-tcp

Teen Connection Project (TCP) The goal of this research project is to evaluate an online, seven session mentoring and skill-building program for TGMY (ages 14-18) called Teen Connection ...

3. clinicaltrial.be clinicaltrial.be/fr/details/451023?per_page=100&only_recruiting=0&only_eligible=0

Evaluation of Teen Connection Project for Trans and Gende... 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 ...

4. reporter.nih.gov reporter.nih.gov/project-details/10878767

Project Details - NIH RePORTER This study represents the first RCT of a TGMY-specific mentoring program developed to prevent psychosocial and behavioral health issues. Public Health Relevance ...

5. withpower.com withpower.com/trial/phase-anxiety-6-2024-5e103

Mentoring Program for Transgender Youth (TCP Trial) 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) ...

6. wymancenter.org wymancenter.org/research-learning/summary-of-tcp-results/

TCP Results The Teen Connection Project (TCP) is evidence-based. The following summarizes TCP results conducted over the last 20 years.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/39/NCT06587139/ICF_000.pdf

23676 ClinicalTrials.gov ID: NCT06587139 Project Title Project Title: Evaluation of Teen Connection Project for Trans and Gender Minority Youth. (TCP). Principal Investigator: Dr. Katie M Edwards, PhD, University ...

8. researchgate.net researchgate.net/publication/383322179_It_changed_me_for_the_better_Feasibility_acceptability_and_safety_of_an_online_program_for_sexual_and_gender_minority_youth_to_prevent_alcohol_use_and_teen_dating_violence

“It changed me for the better”: Feasibility, acceptability, and ... “It changed me for the better”: Feasibility, acceptability, and safety of an online program for sexual and gender minority youth to prevent ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11250281/

Mental Health of Transgender Youth Following Gender ... These results demonstrate that transgender youth have a high risk of running away and attempting suicide and these risks tend to increase as ...