Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-30 @ 8:30 AM
Study NCT ID:
NCT05126134
Status:
COMPLETED
Last Update Posted:
2022-07-29
First Post:
2021-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000068116', 'term': 'Gender Dysphoria'}, {'id': 'D001523', 'term': 'Mental Disorders'}], 'ancestors': [{'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-26', 'studyFirstSubmitDate': '2021-11-03', 'studyFirstSubmitQcDate': '2021-11-16', 'lastUpdatePostDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'list of diagnoses of mental disorders', 'timeFrame': 'enrollment', 'description': 'description of the prevalence of psychiatric comorbidities present in adolescents receiving follow-up in a specialized consultation on gender dysphoria using Diagnostic and Statistical Manual of Mental Disorders 5'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mental disorders'], 'conditions': ['Gender Dysphoria, Adolescent']}, 'descriptionModule': {'briefSummary': 'The number of adolescents engaging in a transidentity journey has been increasing rapidly over the last decade. However, the knowledge of the medical world concerning the specificities of these adolescents is still too little in France. The objective of this study is to refine the knowledge of the different health care providers who are brought to meet these adolescents. This research proposes to study more specifically the register of psychological vulnerabilities: to cite only a few examplesThese include disorders such as depression, anxiety disorders and eating disorders, all of which cause suffering and difficulties in everyday life. A better understanding of the presence or absence and the distribution of these different types of vulnerabilities among transgender adolescents would allow, among other things, to promote their their screening by health care providers. This better screening would allow doctors to physicians to offer targeted treatment for these disorders in parallel with the transition process. transition process.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adolescents receiving follow-up in a specialized consultation on gender dysphoria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 12 and 18 years old\n* Be followed up at the gender consultation of the Toulouse University Hospital\n\nExclusion Criteria:\n\n* Have not yet completed the first consultation on gender issues at the time of selection.\n* Have only one last appointment with the gender consultation at the time of selection'}, 'identificationModule': {'nctId': 'NCT05126134', 'acronym': 'VATED', 'briefTitle': 'Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Psychological Vulnerabilities and Transgender Adolescents: A Descriptive Epidemiology Study', 'orgStudyIdInfo': {'id': 'RC31/21/0385'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adolescents followed for gender dysphoria', 'description': "The data collection by the examiner takes place during a single interview centered around the child's completion of a semi-structured questionnaire: the Kiddie Schedule for Affective Disorders and Schizophrenia. The child is interviewed alone and then with an accompanying parent.", 'interventionNames': ['Diagnostic Test: KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)']}], 'interventions': [{'name': 'KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia)', 'type': 'DIAGNOSTIC_TEST', 'description': 'completion of the semi-structured questionnaire: the KSADS (Kiddie Schedule for Affective Disorders and Schizophrenia). The duration is 1h30 to 2h', 'armGroupLabels': ['adolescents followed for gender dysphoria']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toulouse', 'country': 'France', 'facility': 'Chu Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Sophie Çabal-Berthoumieu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}