TransHealthGUIDE: Transforming Health for Gender-Diverse Youth

Gender Identity Clinical Trial

Official title: TransHealthGUIDE: Transforming Health for Gender-Diverse Youth Using Interventions to Drive Equity

Status Not yet recruiting

Clinical Trial 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) youth ages 15-24 years and their caregivers. The goal of the study is to examine the effects of exposure to the app on TGD youth 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 12 months of observation, during which access to the intervention is maintained. Assessments will be performed every 3 months over the 18 month period to document changes in mental health outcomes, and the two groups will be compared.

The investigators plan to enroll 500 TGD youth and their caregivers, with at least 50% (250 participants) to identify as Black, Indigenous, People of Color (BIPOC) and 50% (125 TGD youth, 125 caregivers) to be youth-caregiver dyads.

Ongoing process reassessments will be performed to maximize effectiveness of the intervention, including focus groups and in-depth interviews with TGD youth, 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, school 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.

Clinical Trial Description

The investigators anticipate at least 80% retention across 12 mo of follow-up. This will allow detection of a reduction in suicidal ideation (primary outcome) from 40% at baseline to 26.3% or lower at 12-mo follow-up, as well as changes in the rate of psychological distress and anxiety (secondary outcome). Changes in perceptions of caregiver support and communication will also be assessed, as these are key mechanisms by which the study proposes to improve mental health outcomes. Data analysis will be performed according to intention to treat. ;

Related Conditions & MeSH terms

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

• NCT number: NCT06177600
• Study type: Interventional
• Source: Boston Children's Hospital
• Contact: Nicholas Fisher
• Phone: 6179192643
• Email: nicholas.fisher@childrens.harvard.edu
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Completion date: August 31, 2026