TransHealthGUIDE: Transforming Health for Gender-Diverse Youth

Study Overview
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Brief Summary
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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 15-25 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. We 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. We will perform ongoing process reassessment 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. We 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. We will analyze data across racial minority groups to ensure that the intervention is effective for all racial minorities; if there are discrepancies in effectiveness, we will perform additional mixed methods evaluation to identify and address potential causes.

Detailed Description
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We anticipate at least 80% retention across 12 mo of follow-up. This will allow us to detect 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). We will also assess changes in perceptions of caregiver support and communication, as these are key mechanisms by which we propose to improve mental health outcomes. Data analysis will be performed according to intention to treat.

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

Conditions
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Transgender Persons, Health Services for Transgender Persons, Gender Identity

Intervention / Treatment
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* Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) youth and caregivers


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The study population will consist of gender diverse individuals aged 15-25 years and their caregivers. Primary recruitment will include a random sample of 500 gender diverse individuals between the ages of 15 and 25 years and their caregivers. Exclusion Criteria: Participants will be excluded from the study if they cannot speak, read, and write English or have access to a device with internet access.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Deferred Access<br>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) youth and caregivers<br>* We 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.<br>* Other names: THE GUIDE;|
| Experimental: Immediate Access<br>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) youth and caregivers<br>* We 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.<br>* Other names: THE GUIDE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-SSRS | Measure of suicidal ideation | Baseline and every 3 months through 12 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PHQ-9 | Measure of depression | Baseline and every 3 months through 12 months post intervention | 
| GAD-7 | Measure of anxiety | Baseline and every 3 months through 12 months post intervention | 
| Transgender Family Acceptance to Empowerment Scale (TransFATE) | Measure of perceived family acceptance | Baseline and every 3 months through 12 months post intervention | 
| Family Adaptability and Cohesion Scale (FACES IV) | Measure of family communication and acceptance | Baseline and every 3 months through 12 months post intervention | 
| NSSI | Measure of Self-Harm | Baseline and every 3 months through 12 months post intervention |