Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:14 PM
Study NCT ID:
NCT06177600
Status:
RECRUITING
Last Update Posted:
2025-08-20
First Post:
2023-12-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017028', 'term': 'Caregivers'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2023-12-11', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measure of past 3-month suicidality. Presence or absence of past 3-month suicidal ideation and risk.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder 2-item (GAD-2)', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': '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.'}, {'measure': 'SOARS Model of Non-suicidal Self-Injury', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measure of non-suicidal self-injury. Presence or absence of past 3-month non-suicidal self-injury.'}, {'measure': 'TransFATE Family Acceptance Scale', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measure of family acceptance. Score range is 0-36 (higher scores indicate higher degree of family acceptance).'}, {'measure': 'Family Adaptability and Cohesion Scale (FACES IV), Family Communication Subscale', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measure of family communication. Score range is 0-32 (higher scores indicate higher degree of family communication).'}, {'measure': 'Family Adaptability and Cohesion Scale (FACES IV), Family Satisfaction Subscale', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measure of family satisfaction. Score range is 0-32 (higher scores indicate higher degree of family satisfaction).'}, {'measure': 'Child-Parent Relationship Scale (CPRS)', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measure of family relationship closeness. Score range is 0-24 (higher scores indicate higher degree of closeness).'}, {'measure': 'Multidimensional Scale of Perceived Social Support (MSPSS)', 'timeFrame': 'Baseline, 3, 6, and 12 months', 'description': 'Measure of social support. Score range is 0-36 (higher scores indicate more support).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transgender Persons', 'Health Services for Transgender Persons', 'Gender Identity']}, 'referencesModule': {'references': [{'pmid': '41218206', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.\n\nThe 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.\n\nOngoing 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '29 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Young adult participants between the ages of 18-29 must identify as transgender or gender expansive.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* 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\n\nExclusion Criteria:\n\n* Inability to speak, read, and write English\n* Lack of device with Internet access\n* Current residence in location other than California, Oregon, Illinois, Maryland, District of Columbia, Vermont, Connecticut, Massachusetts, Michigan, New Jersey, or New York'}, 'identificationModule': {'nctId': 'NCT06177600', 'briefTitle': 'TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'TransHealthGUIDE: Transforming Health for Gender-Diverse Young Adults Using Interventions to Drive Equity', 'orgStudyIdInfo': {'id': 'IRB-P00046532'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Deferred Access', 'description': '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.', 'interventionNames': ['Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers']}, {'type': 'EXPERIMENTAL', 'label': 'Immediate Access', 'description': '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.', 'interventionNames': ['Behavioral: Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers']}], 'interventions': [{'name': 'Interactive educational digital platform for transgender and gender-diverse (TGD) young adults and caregivers', 'type': 'BEHAVIORAL', 'otherNames': ['THE GUIDE'], 'description': '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.\n\nUsers 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.', 'armGroupLabels': ['Deferred Access', 'Immediate Access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cassandra Morrow', 'role': 'CONTACT', 'email': 'theguide@childrens.harvard.edu'}], 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Cassandra Program Manager', 'role': 'CONTACT', 'email': 'theguide@childrens.harvard.edu', 'phone': '617-919-1369'}, {'name': 'Cassandra Morrow', 'role': 'CONTACT', 'email': 'theguide@childrens.harvard.edu'}], 'overallOfficials': [{'name': 'Rena Xu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Surgery', 'investigatorFullName': 'Rena Xu', 'investigatorAffiliation': "Boston Children's Hospital"}}}}