Digital Platform for Transgender Mental Health

Overseen By Nicholas Fisher

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

Trial Summary

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 data supports the effectiveness of this treatment for transgender mental health?

Research shows that e-health services, like digital platforms, can be effective and beneficial for transgender and gender-diverse people, improving health-related outcomes and being easy to use in daily life. Additionally, gender-affirming approaches in healthcare are experienced as supportive and respectful by transgender individuals, suggesting that a digital platform with these features could be effective. ^{1 2 3 4 5}

How is the digital platform for transgender mental health different from other treatments?

This digital platform is unique because it provides an interactive and educational online space specifically designed for transgender and gender-diverse young adults and their caregivers, offering a safe and affirming environment that traditional mental health services often lack. ^{6 7 8 9 10}

What is the purpose of this trial?

This is a randomized controlled trial to test the effectiveness of an interactive educational app-based digital intervention that provides knowledge and support to transgender and gender-diverse (TGD) young adults ages 18-24 years and their caregivers. The goal of the study is to examine the effects of exposure to the app on TGD young adult mental health outcomes. Participants will be randomized to an Immediate Arm (access to a digital platform, plus usual care) or a Deferred Arm (usual care; access to the digital platform at 6 mo). 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. For each Arm, the intervention period will last 6 months, followed by 6 months of observation, during which access to the intervention is maintained. Assessments will be performed at baseline, 3, 6, and 12 months to document changes in mental health outcomes, and the two groups will be compared. The investigators plan to enroll 500 TGD young adults and their caregivers, with at least 50% (250 participants) to identify as Black, Indigenous, People of Color (BIPOC) and 50% (125 TGD young adults, 125 caregivers) to be young adult-caregiver dyads. Ongoing process reassessments will be performed to maximize effectiveness of the intervention, including focus groups and in-depth interviews with TGD young adults, caregivers, and providers, as well as analysis of data collected through the digital platform and participant surveys. Investigators will account for sociodemographic characteristics such as race and ethnicity, age, gender identity, education status, existing mental health conditions, and history of suicidal ideation or attempt. Data will be analyzed across racial minority groups to ensure that the intervention is effective for all racial minorities; if there are discrepancies in effectiveness, additional mixed methods evaluation will be performed to identify and address potential causes.

Research Team

Rena Xu

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Identify, Engage, Understand: Supporting Transgender Youth in an Inpatient Psychiatric Hospital. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Psychiatric Epidemiology of Transgender and Nonbinary Adult Patients at an Urban Health Center. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Need for Inclusive Consideration of Transgender and Gender Diverse People in E-Health Services: A Systematic Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Exploring the Minnesota Multiphasic Personality Inventory (MMPI)-3 in a transgender and gender diverse sample. [2023]

6. United States 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. [2021]

7. Canada pubmed.ncbi.nlm.nih.gov

Co-design of the Transgender Health Information Resource: Web-Based Participatory Design. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Trans and gender diverse young people's attitudes towards game-based digital mental health interventions: A qualitative investigation. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility Study of an Online Intervention to Support Male Spouses of Women With Breast Cancer. [2022]

10. England 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. [2023]