Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-25 @ 9:22 PM
Study NCT ID:
NCT05168956
Status:
COMPLETED
Last Update Posted:
2023-02-28
First Post:
2021-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics of Genealogical Representations of Perpetrators of Sexual Violence.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-27', 'studyFirstSubmitDate': '2021-12-10', 'studyFirstSubmitQcDate': '2021-12-10', 'lastUpdatePostDateStruct': {'date': '2023-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characteristic of family', 'timeFrame': 'the day of the medical file review', 'description': 'Structural characteristic of family tree according to the penal category Collected in medical record.'}], 'secondaryOutcomes': [{'measure': 'Family members', 'timeFrame': 'the day of the medical file review', 'description': 'Number of members in the sibling, rank in the sibling collected in medical record.'}, {'measure': 'Incestuous relationships', 'timeFrame': 'the day of the medical file review', 'description': 'Number of incestuous relationships in the family collected in medical record.'}, {'measure': 'Psychological traumatisms: sexual abuse', 'timeFrame': 'the day of the medical file review', 'description': 'Existence of psychological traumatisms: sexual abuse collected in medical record.'}, {'measure': 'Psychological traumatisms: brutal deat', 'timeFrame': 'the day of the medical file review', 'description': 'Existence of psychological traumatisms: brutal deat collected in medical record.'}, {'measure': 'Psychological traumatisms: severe illness', 'timeFrame': 'the day of the medical file review', 'description': 'Existence of psychological traumatisms: severe illness collected in medical record.'}, {'measure': 'Psychological traumatisms: suicide', 'timeFrame': 'the day of the medical file review', 'description': 'Existence of psychological traumatisms: suicide collected in medical record.'}, {'measure': 'Criminal category', 'timeFrame': 'the day of the medical file review', 'description': 'Criminal category collected in medical record.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sexual abuse', 'family', 'sexual offenders', 'incest'], 'conditions': ['Sexual Offence']}, 'descriptionModule': {'briefSummary': 'Two French studies report that 25% of sexual abuse occurs in intrafamily sphere. To be victim of sexual abuse leads to cognitive troubles and redesign of psychological processes. Lot of studies report that offenders had been victims (30-97%). How psychological redesign is destroying genealogical representation and hinders the proper construction of family ties.\n\nThis study to study characteristics data about family, and how the patients see it, from medical records of a specific department for sexual offenders in University Hospital of Saint Etienne. Study is realized blind from criminal categories. Data are gathered with a standardized grid, to guarantee reproducibility of data collection.', 'detailedDescription': "The CARG-AVS study does not involve any additional examinations or consultations compared to usual practice. It consists of collecting information from patients' medical records."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients followed up in the sexual offender's department of University Hospital of Saint Etienne will be included.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients followed up in the sexual offender's department of University Hospital of Saint Etienne.\n* Patients who did the nursing assessment at time of analysis.\n\nExclusion Criteria:\n\n* Patients in the preliminary follow up in the department\n* Refusal to participate at this study"}, 'identificationModule': {'nctId': 'NCT05168956', 'acronym': 'CARG-AVS', 'briefTitle': 'Characteristics of Genealogical Representations of Perpetrators of Sexual Violence.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Apparent Characteristics of Genealogical Representations of Perpetrators of Sexual Violence.', 'orgStudyIdInfo': {'id': 'IRBN1052021/CHUSTE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sexual offender', 'description': "Patients followed up in the sexual offender's department of University Hospital of Saint Etienne will be included.", 'interventionNames': ['Other: Collect data of medical record']}], 'interventions': [{'name': 'Collect data of medical record', 'type': 'OTHER', 'description': 'Collect data of medical record:\n\n* Genealogy characteristics\n* Family characteristics: Number of members in the sibling, rank in the sibling / incestuous relationships or not\n* Graphic representation: age / gender / age at time of sexual assault / whether or not a victim of sexual violence / education / family dynamics / living environment during childhood / Criminal category', 'armGroupLabels': ['Sexual offender']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Tristan GABRIEL, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}