TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

NCT06177600 | Recruiting DMC

• 1 other identifier: IRB-P00046532
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Generalized Anxiety Disorder 2-item (GAD-2)

  Baseline, 3, 6, and 12 months

• SOARS Model of Non-suicidal Self-Injury

  Baseline, 3, 6, and 12 months

• TransFATE Family Acceptance Scale

  Baseline, 3, 6, and 12 months

• Family Adaptability and Cohesion Scale (FACES IV), Family Communication Subscale

  Baseline, 3, 6, and 12 months

• Family Adaptability and Cohesion Scale (FACES IV), Family Satisfaction Subscale

  Baseline, 3, 6, and 12 months

Study Arms (2)

Deferred Access

OTHER

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

Immediate Access

EXPERIMENTAL

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

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.

Also known as: THE GUIDE

Deferred Access; Immediate Access

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: Young adult participants between the ages of 18-29 must identify as transgender or gender expansive.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (1)

• Reisner SL, Cole SW, Keuroghlian AS, Katz-Wise SL, Morrow C, Kane K, Feng C, Xu R. Transforming Mental Health for Transgender and Gender-Diverse Young Adults Using Interventions to Drive Equity (TransHealthGUIDE): Protocol for a Digital Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 11;14:e78619. doi: 10.2196/78619.

  PMID: 41218206 DERIVED

MeSH Terms

Interventions

Caregivers

Intervention Hierarchy (Ancestors)

Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Rena Xu

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra Program Manager

CONTACT

617-919-1369; theguide@childrens.harvard.edu

Cassandra Morrow

CONTACT

theguide@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: 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.

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: April 23, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)