Digital Platform for Transgender Mental Health

Overseen By Cassandra Program Manager

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Non-English speakers, No internet, Others

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

Compensation: Varies

Number of Visits: 6

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a digital app designed to support the mental health of transgender and gender-diverse young adults. Participants will either receive immediate access to the app or gain access after six months to assess its impact on their mental health over time. The trial aims to determine the app's effectiveness in improving mental health outcomes for these individuals. Young adults aged 18-29 who identify as gender diverse and live in specific states, along with their caregivers, are encouraged to participate. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could significantly enhance mental health support for gender-diverse communities.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual care, which includes access to resources and support organizations.

What prior data suggests that this digital platform is safe for transgender and gender-diverse young adults?

Research has shown that digital health tools can be safe and helpful for transgender and gender-diverse (TGD) people. A review of digital programs for LGBTQ+ youth found that participants generally received them well, experiencing positive mental health benefits. Another study emphasized the importance of involving TGD individuals in designing these apps to ensure ease of use and support.

Digital platforms like the one under study mainly provide information and support. Since they are not medications, they typically don't cause physical side effects. However, their effectiveness and helpfulness can vary from person to person. It's important to remember that while these platforms aim to support mental health, they should be used alongside other care and resources. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this digital platform for transgender mental health because it offers an interactive and personalized approach to support. Unlike traditional therapy or support groups, this digital app provides immediate access to educational resources and community support tailored specifically for transgender and gender-diverse young adults and their caregivers. It uniquely integrates a digital format that allows 24/7 accessibility, which is especially beneficial for those who may not have easy access to in-person resources. The platform also emphasizes caregiver involvement, which can enhance the support network for users. Overall, this innovative approach aims to fill gaps in mental health care by providing timely, relevant, and accessible support.

What evidence suggests that this digital platform is effective for improving mental health outcomes in transgender and gender-diverse young adults?

Research has shown that digital platforms can improve mental health for transgender and gender-diverse (TGD) people. A review found that these online tools support health and well-being in these communities. Studies indicate that such platforms provide support and resources that enhance mental health for LGBTQ+ youth. In this trial, participants in the "Immediate Access" arm will receive access to the digital app immediately, while those in the "Deferred Access" arm will gain access after 6 months. The digital app being tested aims to offer similar benefits by providing interactive educational content. Early results suggest that these tools can effectively reduce stress and improve mental wellness among TGD young adults. The app could be a valuable resource for boosting mental health in this group. ^{1 2 3 5 6}

Who Is on the Research Team?

Rena Xu

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for transgender and gender-diverse young adults aged 18-24, along with their caregivers. Participants must have a score of 1 or more on the PHQ-9, indicating some level of depression symptoms. Caregivers of individuals aged 15-24 are also eligible. The study aims to include a diverse group with at least half identifying as BIPOC.

Inclusion Criteria

I am a caregiver of a gender diverse individual aged 18-24 in specific states.

I am a gender diverse individual, aged 18-24, living in one of the specified states.

Exclusion Criteria

Inability to speak, read, and write English

Lack of device with Internet access

Current residence in location other than California, Oregon, Illinois, Maryland, District of Columbia, Vermont, Connecticut, Massachusetts, New Jersey, or New York

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the Immediate Arm receive access to a digital app and usual care, while those in the Deferred Arm receive usual care and access to the app after 6 months

6 months

Assessments every 3 months

Observation

Participants are observed for changes in mental health outcomes while maintaining access to the intervention

9 months

Assessments every 3 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention period

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers

Trial Overview The trial tests an app-based educational platform designed for TGD young adults and their caregivers against usual care resources. It's randomized: one group gets immediate access to the app plus usual care; another waits six months before getting the app. Mental health outcomes will be compared over a period of up to 15 months.

How Is the Trial Designed?

Group I: Immediate Access Experimental Treatment 1 Intervention

Immediate access participants will have access to a digital app, plus usual care, after enrollment and the deployment of the app. Usual care consists of access to published resources and community support organizations, if available. The list of resources will include contact information for a suicide prevention hotline.

Group II: Deferred Access Experimental Treatment 1 Intervention

Deferred access participants will be given usual care and gain access to the digital app at 6 months. Usual care consists of access to published resources and community support organizations, if available. The list of resources will include contact information for a suicide prevention hotline.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

In a study of 201 transgender and nonbinary adults, psychiatric disorders were found to be highly prevalent, with male sex assignment at birth linked to lower odds of psychiatric diagnoses.

Factors such as later hormone initiation and the absence of psychiatrist integration into primary care were associated with increased odds of substance use disorders and higher acuity in mental health issues, highlighting the need for integrated care approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychiatric Epidemiology of Transgender and Nonbinary Adult Patients at an Urban Health Center. Beckwith, N., McDowell, MJ., Reisner, SL., et al.[2020]

The MMPI-3, a psychological assessment tool, demonstrated reliable and valid psychometric properties when used with a sample of 97 transgender and gender diverse (TGD) individuals, indicating it can effectively assess their mental health needs.

Compared to previous studies, TGD individuals not currently in mental health treatment showed fewer differences in MMPI-3 scores from the normative sample, suggesting improved mental health functioning in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Minnesota Multiphasic Personality Inventory (MMPI)-3 in a transgender and gender diverse sample. Bryant, WT., Livingston, NA., McNulty, JL., et al.[2023]

Transgender adolescents in inpatient psychiatric care generally experience a supportive environment, largely due to care providers' efforts to respect their gender identity and use preferred identifiers, as reported in interviews with 9 patients and 18 providers.

However, barriers to consistent support were identified, including issues with how transgender identities are recorded in medical systems and a lack of training for providers in transgender cultural competency, which can hinder optimal care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identify, Engage, Understand: Supporting Transgender Youth in an Inpatient Psychiatric Hospital. Acosta, W., Qayyum, Z., Turban, JL., et al.[2020]

The study successfully utilized web-based participatory design methods to develop a mobile app aimed at providing credible health information for the transgender and gender-diverse community, demonstrating high engagement with 301 influential interactions during a single design session.

This approach not only maintained the effectiveness of traditional in-person design sessions but also improved accessibility for participants who may be geographically distant from academic institutions, highlighting the feasibility of remote collaboration in health resource development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-design of the Transgender Health Information Resource: Web-Based Participatory Design. Morse, B., Soares, A., Ytell, K., et al.[2023]

The Trans Collaborations Clinical Check-in (TC3) is a newly developed 18-item self-report measure designed to monitor the behavioral health progress of transgender and gender diverse (TGD) individuals, validated through a study involving 215 participants.

Higher TC3 scores, indicating better adjustment and comfort with gender, were linked to lower levels of depression and anxiety, as well as greater life satisfaction and community belonging, suggesting its effectiveness as a clinical tool for TGD mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans Collaborations Clinical Check-In (TC3): Initial Validation of a Clinical Measure for Transgender and Gender Diverse Adults Receiving Psychological Services. Holt, NR., Huit, TZ., Shulman, GP., et al.[2023]

A study involving 260 transgender and gender diverse youth aged 14-22 found that the internet provides crucial affirming spaces that help protect against psychological distress and promote well-being, which are often lacking in their offline lives.

Participants reported five key processes through which online experiences foster resilience: escaping stigma and violence, experiencing belonging, building confidence, feeling hope, and giving back, highlighting the importance of supportive online communities for TGD youth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

It's my safe space: The life-saving role of the internet in the lives of transgender and gender diverse youth. Austin, A., Craig, SL., Navega, N., et al.[2021]

Trans and gender diverse (TGD) young people face significant mental health challenges, with high rates of anxiety, depression, and suicide attempts, highlighting the need for effective support systems.

Focus group discussions with 14 TGD youth suggest that digital games could serve as a valuable mental health intervention, emphasizing the importance of inclusivity in game content and the potential for these interventions to address a range of mental health symptoms, from preventative to clinical.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trans and gender diverse young people's attitudes towards game-based digital mental health interventions: A qualitative investigation. Strauss, P., Morgan, H., Wright Toussaint, D., et al.[2022]

The Male Transition Toolkit (MaTT) was found to be a feasible and acceptable web-based psychosocial intervention for male spouses of women with breast cancer, based on a randomized controlled trial with 40 dyads over four weeks.

While the intervention did not significantly change quality of life scores between groups, a decrease in caregiver guilt was associated with an increase in the quality of life for male spouses, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility Study of an Online Intervention to Support Male Spouses of Women With Breast Cancer. Duggleby, W., Ghosh, S., Struthers-Montford, K., et al.[2022]

A randomized controlled trial involving 467 participants showed that using video clips of transgender adolescents significantly improved knowledge and attitudes towards transgender and gender diverse (TGD) youth compared to presentations without videos.

The effectiveness of the intervention was consistent across different presenters, indicating that a well-informed speaker can enhance understanding of TGD issues, regardless of their own gender identity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborating with transgender youth to educate healthcare trainees and professionals: randomized controlled trial of a didactic enhanced by brief videos. Martin, A., Celentano, J., Olezeski, C., et al.[2023]

E-health services have been shown to effectively improve health-related outcomes for transgender and gender diverse (TGD) individuals, as well as enhance the professional expertise of healthcare providers, based on a systematic review of 27 studies from 8 countries.

Users of e-health services reported that these platforms are helpful and easily integrated into their daily lives, suggesting a positive acceptability and feasibility for improving access to trans health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Need for Inclusive Consideration of Transgender and Gender Diverse People in E-Health Services: A Systematic Review. Renner, J., Täuber, L., Nieder, TO.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9493149/

Transgender Individuals and Digital Health - PMC The goal of this review is to assess the use of digital technologies to promote the health and well-being of transgender and gender diverse (TGD) people.

2. withpower.com withpower.com/trial/phase-health-services-for-transgender-persons-2024-501ef

Digital Platform for Transgender Mental Health The goal of the study is to examine the effects of exposure to the app on TGD young adult mental health outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10556462/

Digital intervention in improving the outcomes of mental ... This systematic review incorporated 15 empirical studies on digital interventions' impact on LGBTQ+ youth mental health, examining their potential to address ...

4. ctv.veeva.com ctv.veeva.com/study/transhealthguide-transforming-health-for-gender-diverse-youth

Transforming Health for Gender-Diverse Young Adults This is a randomized controlled trial to test the effectiveness of an interactive educational app-based digital intervention that provides ...

5. formative.jmir.org formative.jmir.org/2025/1/e73180

The Alongside Digital Wellness Program for Youth Evaluating the accessibility, engagement, and effectiveness of alongside digital mental health app components in middle and high schools.

6. nature.com nature.com/articles/s41746-025-01668-1

A systematic review of developments in mHealth ... The review aimed to identify key features of mHealth apps developed for TGD individuals, focusing on theoretical frameworks, design strategies, and their ...