Digital Platform for Transgender Mental Health

Recruiting in Palo Alto (17 mi)

Overseen by Rena Xu

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Boston Children's Hospital

Disqualifiers: Non-English speakers, No internet, Others

No Placebo Group

Trial Summary

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 9 months of observation, during which access to the intervention is maintained. Assessments will be performed every 3 months over the 15 month period 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.

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}

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

Trial 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 (Behavioral Intervention)

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Children's Hospital Boston, MA

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Patients Recruited

5,584,000+

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] One key aspect of evidence-based psychological services is monitoring progress to inform treatment decision making, often using a brief self-report measure. However, no such measure exists to support measurement-based care, given the distinct needs of transgender and gender diverse people (TGD), a group facing large documented health disparities and marginalization in health care. The purpose of the present study was to develop and provide initial psychometric validation of a short, behavioral health progress monitoring self-report measure, the Trans Collaborations Clinical Check-in (TC3). TGD communities, providers identified as TGD-affirmative, and relevant academic experts contributed to item and scale development. The final 18-item version was administered to 215 TGD adults (75 transfeminine, 76 transmasculine, 46 nonbinary, 18 unknown; mean age of 30 with a range of 19 to 73), who were recruited for an online study, with other questionnaires assessing negative affect, well-being, gender dysphoria, gender minority stressors, and resilience. Higher scores on the TC3 (indicating better adjustment and comfort with gender) were generally associated with lower depression, anxiety, minority stress, and gender dysphoria and greater life satisfaction, body congruence, and positive aspects of being TGD such as pride in identity and community belongingness. These results support the validity of the TC3 as a brief measure to be used as a clinical tool for TGD people receiving mental health services. Additional research is needed on the reliability and validity of the TC3 across multiple time points to determine utility as a progress monitoring measure. The TC3 should also be further validated with more culturally diverse samples.

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

Identify, Engage, Understand: Supporting Transgender Youth in an Inpatient Psychiatric Hospital. [2020] Transgender adolescents may require for inpatient psychiatric care, and have unique healthcare needs and can face barriers to quality care. This study sought to address limited understanding of the inpatient experience of transgender adolescents. This study uses qualitative methods to gain insight into the experience of transgender adolescents and psychiatric care providers on an adolescent inpatient psychiatric unit in the northeast United States. Semi-structured interviews were conducted with patients (9 total, ages 13-17) and unit care providers (18 total). These interviews were recorded, transcribed, and analyzed using inductive thematic analysis. Patients and providers generally reported a supportive inpatient environment. Factors that contributed to this environment were efforts by care providers to respect patients regardless of gender identity, to use patient's preferred identifiers, and to acknowledge mistakes in identifier use. Barriers to consistently supportive interactions were also identified, including a lack of consistent identification of a patient's transgender identity in a supportive manner during the admission intake, challenges associated with the presence of birth-assigned name and gender within the care system (e.g. in the electronic medical record, identifying wristbands, attendance rosters), and a lack of formal training of care providers in transgender cultural competency. Interviews also provided insight into how providers grapple with understanding the complexities of gender identity. Findings suggest that gender-affirming approaches by providers are experienced as supportive and respectful by transgender adolescent patients, while also identifying barriers to consistently supportive interactions that can be addressed to optimize care.

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

Psychiatric Epidemiology of Transgender and Nonbinary Adult Patients at an Urban Health Center. [2020] Transgender and nonbinary people have an increased burden of psychiatric problems compared with the general population. Data are needed to understand factors associated with psychiatric diagnoses, acuity in terms of suicide attempts and level-of-care escalation, and outpatient engagement among transgender and nonbinary adults.

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] Many transgender and gender diverse (TGD) people use the internet to find ways out of isolation, network, and share information on health-related topics. Thus, e-health services could reduce the health burden of TGD people and facilitate access to health care. Following the PRISMA guidelines, we conducted a systematic review on e-health approaches that could improve trans health care (i.e., services directly for TGD people or training programs for health care professionals, HCPs) and their effectiveness, acceptability, and feasibility. We searched PubMed, Web of Science, and PubPsych databases for publications from January 2000 to June 2021 with final updates before publication. The systematic review identified e-health services across 27 studies from 8 different countries. Few studies evaluated e-health services exclusively for TGD people. However, use of an e-health service was found to be effective and beneficial: TGD people improved in health-related outcomes, and HCPs improved in professional expertise. Service users find e-health services helpful and easy to integrate into their daily lives. Recommendations for further development of e-health services in trans health care are provided. In the future, given the rapidly evolving e-health research and care field, new treatment approaches for TGD people should be subject to ongoing evaluation and development.

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

Exploring the Minnesota Multiphasic Personality Inventory (MMPI)-3 in a transgender and gender diverse sample. [2023] Comparisons of transgender and gender diverse (TGD) individuals' mental health functioning with that of cisgender individuals rely almost exclusively on screening measures. The limited research with TGD individuals and omnibus assessment measures has primarily used previous iterations of the Minnesota Multiphasic Personality Inventories (MMPIs). This study sought to examine the psychometric functioning of the MMPI-3 with a TGD community sample (n = 97) and compare mean scores across TGD and cisgender subsamples. We expected MMPI-3 substantive scale reliability to be comparable across all samples and subsamples. Individual MMPI-3 scales were expected to demonstrate appropriate convergent and discriminant validity with relevant criterion measures in the TGD sample. Results generally supported MMPI-3 scale score reliability and validity with TGD individuals. Next, three sets of mean score comparisons were conducted across all MMPI-3 substantive scales: (a) TGD individuals not currently in mental health treatment and the MMPI-3 normative sample, (b) TGD individuals not currently in mental health treatment and TGD individuals currently in mental health treatment, and (c) TGD individuals currently in mental health treatment and an outpatient mental health sample. Fewer differences were found between TGD individuals in our sample who were not currently in mental health treatment and the MMPI-3 normative sample compared to previous work. This initial study indicates that MMPI-3 scales largely have appropriate psychometric properties when administered to a TGD sample and that the test may be helpful in identifying mental health needs of TGD individuals. Needs and directions for further research are discussed. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

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] Background: Public awareness of Transgender and Gender Diverse (TGD) identities has grown significantly; however, acceptance and support remain elusive for many TGD youth. Resultant experiences of marginalization and stigmatization contribute to elevated rates of psychological distress and suicidality among TGD youth. Emergent evidence suggests that the internet may offer TGD youth safety, support, and community previously unavailable. Aim: The primary aim of this qualitative inquiry is to engage in an in-depth exploration of the online experiences and processes which help protect against psychological distress and promote well-being among TGD youth. Methods: Data were culled from a mixed-methods, online study of sexual and gender minority youth from across the United States and Canada which followed Institutional Review Board approved protocols. Participants for this study represent a sample (n = 260) of TGD participants aged 14-22 (x̄ = 17.30). Data were analyzed using Charmaz' grounded theory strategies. Results: Data revealed that the internet offers TGD youth affirming spaces that, for the most part, do not exist in their offline lives. Online, TGD youth were able to engage meaningfully with others as their authentic selves, often for the first time. These experiences fostered well-being, healing, and growth through five processes: 1. Finding an escape from stigma and violence, 2. Experiencing belonging, 3. Building confidence, 4. Feeling hope, and 5. Giving back. Discussion: The unique and innovative ways in which participants use online spaces to foster resilience offer important insights to inform affirmative practices with TGD young people.

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

Co-design of the Transgender Health Information Resource: Web-Based Participatory Design. [2023] There is an urgent and unmet need for accessible and credible health information within the transgender and gender-diverse (TGD) community. Currently, TGD individuals often seek and must find relevant resources by vetting social media posts. A resource that provides accessible and credible health-related resources and content via a mobile phone app may have a positive impact on and support the TGD population.

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] Trans and gender diverse (TGD) young people are at high risk for mental health difficulties. Previous research has shown that three in four TGD young people have been diagnosed with an anxiety disorder and/or depression and almost one in two have attempted suicide. TGD young people experience barriers to traditional mental health services, commonly faced with inexperienced providers and discrimination. Video and computer games, as well as online spaces, are sources of resilience for TGD young people. Digital mental health interventions are a feasible, but understudied, approach to consider for this population.

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

Feasibility Study of an Online Intervention to Support Male Spouses of Women With Breast Cancer. [2022] To evaluate the feasibility of a web-based psychosocial supportive intervention entitled Male Transition Toolkit (MaTT). .

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] In collaboration with members of the transgender and gender diverse (TGD) community, we created a didactic resource about the unique needs of TGD youth.