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Behavioral Intervention

Digital Platform for Transgender Mental Health

N/A

Recruiting

Led By Rena Xu

Research Sponsored by Boston Children's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Gender diverse individuals aged 18-24 years residing in California, Oregon, Illinois, Maryland, District of Columbia, Vermont, Connecticut, Massachusetts, New Jersey, or New York

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and every 3 months through 15 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test an educational app for transgender and gender-diverse young adults and their caregivers to see if it improves mental health outcomes. Participants will be split into two groups: one with immediate

Who is the study for?

This trial is for transgender and gender-diverse young adults aged 18-24, along with their caregivers. Participants must have a score of 1 or more on the PHQ-9, indicating some level of depression symptoms. Caregivers of individuals aged 15-24 are also eligible. The study aims to include a diverse group with at least half identifying as BIPOC.

What is being tested?

The trial tests an app-based educational platform designed for TGD young adults and their caregivers against usual care resources. It's randomized: one group gets immediate access to the app plus usual care; another waits six months before getting the app. Mental health outcomes will be compared over a period of up to 15 months.

What are the potential side effects?

Since this intervention is non-medical and involves using an educational digital platform, traditional physical side effects are not expected. However, participants may experience emotional or psychological responses based on the content or support provided through the app.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a gender diverse individual, aged 18-24, living in one of the specified states.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and every 3 months through 15 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and every 3 months through 15 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and every 3 months through 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Columbia Suicide Severity Rating Scale (C-SSRS)

Patient Health Questionnaire-9 (PHQ-9)

Secondary study objectives

Child-Parent Relationship Scale (CPRS)

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

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

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Immediate AccessExperimental Treatment1 Intervention

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.

Group II: Deferred AccessExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met