TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Boston Children's Hospital
Study ID
NCT06177600
Status
Recruiting
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Conditions

  • Gender Identity
  • Health Services for Transgender Persons
  • Transgender Persons

Eligibility Criteria

Sex
ALL
Age
18 Years - 29 Years
Healthy Volunteers
Accepted

Interventions

  • Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers — BEHAVIORAL
    Investigators will develop a free mobile- and web-enabled platform for TGD young adults and their caregivers that combines educational modules with high-quality, evidence-based information and interactive features. At the time of account creation, users will complete an intake survey that will be used to personalize platform features. Young adults will be asked about their goals; mental health; access to health care; degree of caregiver support; and sociodemographic characteristics. Caregivers will be asked about their goals and self-assessed level of supportiveness of their young adults. Users will be assigned educational modules that build knowledge and skills related to improving mental health and navigating relationships and communication with others. Both exposure to and completion of modules will be tracked.

Study Details

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 18-29 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.

Key Dates

Start date
Apr 23, 2025
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
500 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Deferred Access
    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.
  • Experimental: Immediate Access
    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.

Primary Outcome Measure

Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline, 3, 6, and 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Boston Children's HospitalBostonMassachusetts02115
Cassandra Morrow
[email protected]

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By research site
Boston Children's Hospital· Boston, MA

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