Clinical trial NCT06177600: TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults
Official title: TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults Using Interventions to Drive Equity
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Transgender Persons
Health Services for Transgender Persons
Gender Identity
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 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.
Primary purpose: SUPPORTIVE_CARE

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 18-24 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, 3, 6, and 12 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline, 3, 6, and 12 months
Secondary outcomes:
measure: Generalized Anxiety Disorder 2-item (GAD-2)
timeFrame: Baseline, 3, 6, and 12 months
measure: SOARS Model of Non-suicidal Self-Injury
timeFrame: Baseline, 3, 6, and 12 months
measure: TransFATE Family Acceptance Scale
timeFrame: Baseline, 3, 6, and 12 months
measure: Family Adaptability and Cohesion Scale (FACES IV), Family Communication Subscale
timeFrame: Baseline, 3, 6, and 12 months
measure: Family Adaptability and Cohesion Scale (FACES IV), Family Satisfaction Subscale
timeFrame: Baseline, 3, 6, and 12 months
measure: Child-Parent Relationship Scale (CPRS)
timeFrame: Baseline, 3, 6, and 12 months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Baseline, 3, 6, and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Rena Xu
role: PRINCIPAL_INVESTIGATOR
References: