TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

Summary

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.

Conditions

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

Interventions

BEHAVIORAL

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

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.

Sponsors & Collaborators

• Boston Children's Hospital

  lead OTHER

Principal Investigators

• Rena Xu · Boston Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

29 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-23

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• United States

Study Locations