TransHealthGUIDE: Digital support for gender-diverse young adults and their caregivers
TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults Using Interventions to Drive Equity
This trial tests an interactive educational app to support transgender and gender-diverse young adults ages 18-29 and their caregivers and see if using it improves mental health outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 29 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06177600 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial assigns transgender and gender-diverse young adults (ages 18-29) and their caregivers to immediate access to an interactive educational app plus usual care or to a deferred-access usual care arm. The digital platform delivers educational modules and supportive resources and is available to participants for six months with continued observation through 12 months. The primary outcome is reduction in suicidal ideation; secondary outcomes include psychological distress, anxiety, and measures of caregiver support and communication, with assessments at baseline, 3, 6, and 12 months. Analyses follow intention-to-treat and the investigators plan for at least 80% retention to detect a clinically meaningful change in suicidal ideation.
Who should consider this trial
Good fit: Ideal candidates are English-speaking transgender or gender-diverse individuals aged 18-29 and their caregivers who live in California, Oregon, Illinois, Maryland, the District of Columbia, Vermont, Connecticut, Massachusetts, Michigan, New Jersey, or New York and who have a device with internet access.
Not a fit: People who cannot read or speak English, lack a device with internet access, or live outside the listed states would be ineligible and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the app could reduce suicidal thoughts and improve mental health and caregiver communication for transgender and gender-diverse young adults.
How similar studies have performed: Prior digital mental-health programs and family-support interventions for LGBTQ+ youth have shown promise, but rigorous randomized evidence specifically for transgender and gender-diverse young adults is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gender diverse individuals aged 18-29 years residing in California, Oregon, Illinois, Maryland, District of Columbia, Vermont, Connecticut, Massachusetts, Michigan, New Jersey, or New York * Caregivers of gender diverse individuals aged 18-29 years residing in California, Oregon, Illinois, Maryland, District of Columbia, Vermont, Connecticut, Massachusetts, Michigan, New Jersey, or New York 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, Michigan, New Jersey, or New York
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Rena Xu — Boston Children's Hospital
- Study coordinator: Cassandra Program Manager
- Email: theguide@childrens.harvard.edu
- Phone: 617-919-1369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.