Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2025-12-25 @ 1:44 PM
Study NCT ID:
NCT07022392
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation With Parents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All parents and caregivers who agree to participate in the study will receive the same intervention- the TEGS platform. Each will complete surveys at baseline, 1 mo and 3mo after getting access to the platform.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2025-06-06', 'studyFirstSubmitQcDate': '2025-06-06', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'System Usability Scale', 'timeFrame': '1 month and 3 months', 'description': '10 item measure of intervention usability measured on a scale from 0 to 100 with 100 indicating higher usability'}], 'secondaryOutcomes': [{'measure': 'Transgender Family Acceptance To Empowerment scale', 'timeFrame': 'Baseline, 1 month, 3 month', 'description': '16 item measure of parental acceptance and empowerment, measured on a scale of 0 to 80 with 80 indicating a better outcome'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['parents'], 'conditions': ['Parents', 'Usability']}, 'descriptionModule': {'briefSummary': 'This is a small pilot feasibility and acceptability study of implementing a Technology-Enhanced Gender Support (TEGS) platform with parents and caregivers. Parents and caregivers who consent to participate will complete an electronic survey at baseline. They will then receive access to the TEGS platform and complete follow up surveys 1 mo and 3 mo after. Each participant will also be given the option to participate in an exit interview.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Parent of a gender diverse youth aged 8-17\n* Has access to the internet\n* Can speak or read English\n\nExclusion Criteria:\n\n* Not a parent of a gender diverse youth aged 8-17\n* No access to the internet\n* Cannot speak or read in English'}, 'identificationModule': {'nctId': 'NCT07022392', 'acronym': 'TEGS', 'briefTitle': 'Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation With Parents', 'organization': {'class': 'OTHER', 'fullName': "Seattle Children's Hospital"}, 'officialTitle': 'Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation', 'orgStudyIdInfo': {'id': 'STUDY00005068'}, 'secondaryIdInfos': [{'id': 'K08HS029028-01', 'link': 'https://reporter.nih.gov/quickSearch/K08HS029028-01', 'type': 'AHRQ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Technology-Enhanced Gender Support Platform', 'interventionNames': ['Other: Technology-enhanced gender support platform']}], 'interventions': [{'name': 'Technology-enhanced gender support platform', 'type': 'OTHER', 'description': 'Technology-based platform to support parents', 'armGroupLabels': ['Technology-Enhanced Gender Support Platform']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'contacts': [{'name': 'Gina Sequeira, MD, MS', 'role': 'CONTACT', 'email': 'gina.sequeira@seattlechildrens.org', 'phone': '206-987-2028'}, {'name': 'Laura Richardson, MD, MPH', 'role': 'CONTACT', 'email': 'laura.richardson@seattlechildrens.org', 'phone': '206-987-2028'}, {'name': 'Gina Sequeira, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'Gina Sequeira', 'role': 'CONTACT', 'email': 'scgcresearch@seattlechildrens.org', 'phone': '206-987-2028'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Seattle Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Gina Sequeira', 'investigatorAffiliation': "Seattle Children's Hospital"}}}}