THE GUIDE: Transforming Health for Young Adults Using Interventions to Drive Engagement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-29
SponsorBoston Children's Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers
BehavioralInvestigators 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Deferred AccessOther 1 intervention
Group B: Immediate AccessExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Columbia Suicide Severity Rating Scale (C-SSRS)
Measure of past 3-month suicidality. Presence or absence of past 3-month suicidal ideation and risk.
Time frame
Baseline, 3, 6, and 12 months2
Patient Health Questionnaire-9 (PHQ-9)
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.
Time frame
Baseline, 3, 6, and 12 monthsSecondary outcomes
1
Generalized Anxiety Disorder 2-item (GAD-2)
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.
Time frame
Baseline, 3, 6, and 12 months2
SOARS Model of Non-suicidal Self-Injury
Measure of non-suicidal self-injury. Presence or absence of past 3-month non-suicidal self-injury.
Time frame
Baseline, 3, 6, and 12 months3
TransFATE Family Acceptance Scale
Measure of family acceptance. Score range is 0-36 (higher scores indicate higher degree of family acceptance).
Time frame
Baseline, 3, 6, and 12 months4
Family Adaptability and Cohesion Scale (FACES IV), Family Communication Subscale
Measure of family communication. Score range is 0-32 (higher scores indicate higher degree of family communication).
Time frame
Baseline, 3, 6, and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov