Condition: Transgender Persons · Health Services for Transgender Persons · Gender Identity · Sponsor: Boston Children's Hospital
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 …
This description comes directly from the study's public registry record.
Cassandra Program Manager · 617-919-1369 · theguide@childrens.harvard.edu
Cassandra Morrow · theguide@childrens.harvard.edu
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Source record: clinicaltrials.gov/study/NCT06177600