TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults Using Interventions to Drive Equity

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.

Study Overview

• Status: Recruiting
• Conditions: Transgender Persons; Gender Identity; Health Services for Transgender Persons
• Intervention / Treatment: Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cassandra Morrow; Email: theguide@childrens.harvard.edu
• Study Contact Backup: Name: Cassandra Program Manager; Phone Number: 617-919-1369; Email: theguide@childrens.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Cassandra Morrow; Email: theguide@childrens.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: THE GUIDE
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.	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.; Other Names: THE GUIDE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Columbia Suicide Severity Rating Scale (C-SSRS)	Measure of past 3-month suicidality. Presence or absence of past 3-month suicidal ideation and risk.	Baseline, 3, 6, and 12 months
Patient Health Questionnaire-9 (PHQ-9)	Measure of past 2-week depression. Score range is 0-27 (higher scores indicate greater degree of depressive symptoms in past 2 weeks). Score >=10 clinically elevated depressive symptoms.	Baseline, 3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Generalized Anxiety Disorder 2-item (GAD-2)	Measure of past 2-week anxiety. Score range is 0-6 (higher scores indicate higher degree of anxious symptoms in past 2 weeks). Score >=3 clinically elevated anxiety symptoms.	Baseline, 3, 6, and 12 months
SOARS Model of Non-suicidal Self-Injury	Measure of non-suicidal self-injury. Presence or absence of past 3-month non-suicidal self-injury.	Baseline, 3, 6, and 12 months
TransFATE Family Acceptance Scale	Measure of family acceptance. Score range is 0-36 (higher scores indicate higher degree of family acceptance).	Baseline, 3, 6, and 12 months
Family Adaptability and Cohesion Scale (FACES IV), Family Communication Subscale	Measure of family communication. Score range is 0-32 (higher scores indicate higher degree of family communication).	Baseline, 3, 6, and 12 months
Family Adaptability and Cohesion Scale (FACES IV), Family Satisfaction Subscale	Measure of family satisfaction. Score range is 0-32 (higher scores indicate higher degree of family satisfaction).	Baseline, 3, 6, and 12 months
Child-Parent Relationship Scale (CPRS)	Measure of family relationship closeness. Score range is 0-24 (higher scores indicate higher degree of closeness).	Baseline, 3, 6, and 12 months
Multidimensional Scale of Perceived Social Support (MSPSS)	Measure of social support. Score range is 0-36 (higher scores indicate more support).	Baseline, 3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Investigators: Principal Investigator: Rena Xu, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 15, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB-P00046532

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No