TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers
  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 w

Первичные конечные точки

• Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Baseline, 3, 6, and 12 months]
• Patient Health Questionnaire-9 (PHQ-9) [Срок оценки: Baseline, 3, 6, and 12 months]

Вторичные конечные точки (7)

• Generalized Anxiety Disorder 2-item (GAD-2) [Срок оценки: Baseline, 3, 6, and 12 months]
• SOARS Model of Non-suicidal Self-Injury [Срок оценки: Baseline, 3, 6, and 12 months]
• TransFATE Family Acceptance Scale [Срок оценки: Baseline, 3, 6, and 12 months]
• Family Adaptability and Cohesion Scale (FACES IV), Family Communication Subscale [Срок оценки: Baseline, 3, 6, and 12 months]
• Family Adaptability and Cohesion Scale (FACES IV), Family Satisfaction Subscale [Срок оценки: Baseline, 3, 6, and 12 months]
• Child-Parent Relationship Scale (CPRS) [Срок оценки: Baseline, 3, 6, and 12 months]
• Multidimensional Scale of Perceived Social Support (MSPSS) [Срок оценки: Baseline, 3, 6, and 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Boston Children's Hospital — Boston

Публикации

• Reisner SL, Cole SW, Keuroghlian AS, Katz-Wise SL, Morrow C, Kane K, Feng C, Xu R. Transforming Mental Health for Transgender and Gender-Diverse Young Adults Using Interventions to Drive Equity (TransHealthGUIDE): Protocol for a Digital Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 11;14:e78619. doi: 10.2196/78619. PMID 41218206

Идентификаторы

NCT: NCT06177600 · IRB-P00046532

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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