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NCT Number: NCT06177600

TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

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.

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Key information

Conditions

Transgender Persons Gender Identity Health Services for Transgender Persons

Age range

18 year–29 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Cassandra Morrow

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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, Michigan, New Jersey, or New York

Treatment and study plan

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.

Other names: THE GUIDE

Primary outcomes

  1. Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: Baseline, 3, 6, and 12 months

    Measure of past 3-month suicidality. Presence or absence of past 3-month suicidal ideation and risk.

  2. Patient Health Questionnaire-9 (PHQ-9)

    Time frame: Baseline, 3, 6, and 12 months

    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.

Secondary outcomes

  1. Generalized Anxiety Disorder 2-item (GAD-2)

    Time frame: Baseline, 3, 6, and 12 months

    Measure of past 2-week anxiety. Score range is 0-6 (higher scores indicate higher degree of anxious symptoms in past 2 weeks). Score >=3 clinically elevated anxiety symptoms.

  2. SOARS Model of Non-suicidal Self-Injury

    Time frame: Baseline, 3, 6, and 12 months

    Measure of non-suicidal self-injury. Presence or absence of past 3-month non-suicidal self-injury.

  3. TransFATE Family Acceptance Scale

    Time frame: Baseline, 3, 6, and 12 months

    Measure of family acceptance. Score range is 0-36 (higher scores indicate higher degree of family acceptance).

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

    Time frame: Baseline, 3, 6, and 12 months

    Measure of family communication. Score range is 0-32 (higher scores indicate higher degree of family communication).

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

    Time frame: Baseline, 3, 6, and 12 months

    Measure of family satisfaction. Score range is 0-32 (higher scores indicate higher degree of family satisfaction).

  6. Child-Parent Relationship Scale (CPRS)

    Time frame: Baseline, 3, 6, and 12 months

    Measure of family relationship closeness. Score range is 0-24 (higher scores indicate higher degree of closeness).

  7. Multidimensional Scale of Perceived Social Support (MSPSS)

    Time frame: Baseline, 3, 6, and 12 months

    Measure of social support. Score range is 0-36 (higher scores indicate more support).

Study contacts

Contact information is provided by the study sponsor or research team.

Cassandra Morrow

CONTACT

[email protected]

Cassandra Program Manager

CONTACT

[email protected]

617-919-1369

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults Using Interventions to Drive Equity

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2023
Registry last updated
Aug 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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