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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06177600
• Other study ID #: IRB-P00046532
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: Boston Children's Hospital
• Contact: Nicholas Fisher
• Phone: 6179192643
• Email: nicholas.fisher[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 24 Years

Eligibility

Inclusion Criteria:

• Gender diverse individuals aged 15-24 years with score of 1 or more on the Patient Health Questionnaire-9 (PHQ-9)
• Caregivers of gender diverse individuals aged 15-24 years

Exclusion Criteria:

• Inability to speak, read, and write English
• Lack of device with Internet access

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Interactive educational digital platform for transgender and gender-diverse (TGD) youth and caregivers
Investigators will develop a free mobile- and web-enabled platform for TGD youth 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. Youth 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 youth. 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Columbia Suicide Severity Rating Scale (C-SSRS)	Measure of suicidal ideation and risk. Score range of 2-25 (higher score indicates higher ideation).	Baseline and every 3 months through 12 months post intervention
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Measure of depression. Score range is 0-27 (higher scores indicate greater degrees of depressed mood),	Baseline and every 3 months through 12 months post intervention
Secondary	Generalized Anxiety Disorder 2-item (GAD-2)	Measure of anxiety. Score range is 0-6 (higher scores indicate higher level of anxiety).	Baseline and every 3 months through 12 months post intervention
Secondary	Transgender Family Acceptance to Empowerment Scale (TransFATE)	Measure of perceived family acceptance. Score range is 16-80 (higher scores indicate more parental empowerment).	Baseline and every 3 months through 12 months post intervention
Secondary	Family Adaptability and Cohesion Scale (FACES IV)	Measure of family communication and acceptance. Score range is 8-24 (high scores indicate higher levels of acceptance and cohesion.	Baseline and every 3 months through 12 months post intervention
Secondary	SOARS Model of non suicidal self-injury (NSSI)	Measure of Self-Harm.	Baseline and every 3 months through 12 months post intervention