THE GUIDE: Transforming Health for Young Adults Using Interventions to Drive Engagement
Boston Children's Hospital · NCT06177600
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18–29 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Not applicable
- Target enrollment
- 500
- US sites recruiting
- 1
- Study start
- April 23, 2025
- Record last updated
- September 9, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers
Conditions: Transgender Persons; Health Services for Transgender Persons; Gender Identity
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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
Recruiting US locations
Boston Children's Hospital
Boston, MA 02115
Site contact: Cassandra Morrow · theguide@childrens.harvard.edu
Study contacts (from the official record)
- Cassandra Program Manager · 617-919-1369 · theguide@childrens.harvard.edu
- Cassandra Morrow · theguide@childrens.harvard.edu
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