Transgender PersonsNCT06177600
THE GUIDE: Transforming Health for Young Adults Using Interventions to Drive Engagement
A study testing Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers in people with Transgender Persons and Health Services for Transgender Persons, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Transgender Persons, Health Services for Transgender Persons, Gender Identity
- What is being tested?
- Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2025to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cassandra Morrow contact
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Cassandra Morrow, theguide@childrens.harvard.edu
About this study
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.
Read more
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.
Read the detailed description
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.
- Being tested
- Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregiversBehavioural
Also called THE GUIDE
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.
| Study group | Role | What they receive |
|---|---|---|
| Deferred Access | Other | Deferred access participants will be given usual care and gain access to the digital app at 6 months. 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. Receives: Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers |
| Immediate Access | Experimental | Immediate access participants will have access to a digital app, plus usual care, after enrollment and the deployment of the app. 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. Receives: Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Severity Rating Scale (C-SSRS)
Measure of past 3-month suicidality. Presence or absence of past 3-month suicidal ideation and risk.
Measured: Baseline, 3, 6, and 12 months
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.
Measured: Baseline, 3, 6, and 12 months
Secondary outcomes (7)
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.
Measured: Baseline, 3, 6, and 12 months
SOARS Model of Non-suicidal Self-Injury
Measure of non-suicidal self-injury. Presence or absence of past 3-month non-suicidal self-injury.
Measured: Baseline, 3, 6, and 12 months
TransFATE Family Acceptance Scale
Measure of family acceptance. Score range is 0-36 (higher scores indicate higher degree of family acceptance).
Measured: Baseline, 3, 6, and 12 months
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).
Measured: Baseline, 3, 6, and 12 months
Family Adaptability and Cohesion Scale (FACES IV), Family Satisfaction Subscale
Measure of family satisfaction. Score range is 0-32 (higher scores indicate higher degree of family satisfaction).
Measured: Baseline, 3, 6, and 12 months
Child-Parent Relationship Scale (CPRS)
Measure of family relationship closeness. Score range is 0-24 (higher scores indicate higher degree of closeness).
Measured: Baseline, 3, 6, and 12 months
Multidimensional Scale of Perceived Social Support (MSPSS)
Measure of social support. Score range is 0-36 (higher scores indicate more support).
Measured: Baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2023
- Study start23 Apr 2025
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Transgender PersonsStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rena Xu, Boston Children's Hospital
- Investigators
- Rena Xu, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06177600
- Sponsor's protocol ID
- IRB-P00046532
- Status last verified
- Aug 2026
- First submitted
- 11 Dec 2023
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41218206
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE GUIDE: Transforming Health for Young Adults Using Interventions to Drive Engagement
- ClinicalTrials.gov ID
- NCT06177600
- Acronym / sponsor ID
- IRB-P00046532
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 20 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Deferred Access | Other | Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregiversDeferred access participants will be given usual care and gain access to the digital app at 6 months. 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. |
| Immediate Access | Experimental | Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregiversImmediate access participants will have access to a digital app, plus usual care, after enrollment and the deployment of the app. 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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregiversAlso: THE GUIDEInvestigators 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. | Behavioural | Deferred Access, Immediate Access |
Primary outcome
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.
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.
7 secondary outcomes
Generalized Anxiety Disorder 2-item (GAD-2)
Time frame: Baseline, 3, 6, and 12 months
SOARS Model of Non-suicidal Self-Injury
Time frame: Baseline, 3, 6, and 12 months
TransFATE Family Acceptance Scale
Time frame: Baseline, 3, 6, and 12 months
Family Adaptability and Cohesion Scale (FACES IV), Family Communication Subscale
Time frame: Baseline, 3, 6, and 12 months
Family Adaptability and Cohesion Scale (FACES IV), Family Satisfaction Subscale
Time frame: Baseline, 3, 6, and 12 months
Child-Parent Relationship Scale (CPRS)
Time frame: Baseline, 3, 6, and 12 months
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline, 3, 6, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Derived from this study: PubMed 41218206Reisner 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cassandra Morrow contact
Rena Xu principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers in people with Transgender Persons and Health Services for Transgender Persons, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cassandra Program Manager (617-919-1369, theguide@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale (C-SSRS) (time frame: Baseline, 3, 6, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06177600, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.