Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-04-11 @ 12:33 PM
Study NCT ID:
NCT02828969
Status:
UNKNOWN
Last Update Posted:
2016-07-12
First Post:
2016-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical and Social Trajectory of Children and Adolescents With Disruptive Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000066553', 'term': 'Problem Behavior'}, {'id': 'D004630', 'term': 'Emergencies'}, {'id': 'D019955', 'term': 'Conduct Disorder'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002652', 'term': 'Child Behavior'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2016-07-07', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Description of the children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft.', 'timeFrame': 'At inclusion', 'description': 'This study is intended to characterized the population of children and adolescents admitted to emergency rooms for disruptive behavior'}], 'secondaryOutcomes': [{'measure': 'Nature and type of the care management provided to children and adolescents admitted to emergency rooms for disruptive behavior', 'timeFrame': 'At inclusion', 'description': 'Type of care management (hospitalization, reason of admission, type of caregiver at the admission, perception of the care management…)'}, {'measure': "description of patients' perceptions of the care management", 'timeFrame': 'at inclusion', 'description': "the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies."}, {'measure': "description of patients' perceptions of the care management", 'timeFrame': '6 months', 'description': "the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies."}, {'measure': "description of patients' perceptions of the care management", 'timeFrame': '12 months', 'description': "the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies."}, {'measure': "description of patients' perceptions of the care management", 'timeFrame': '24 months', 'description': "the patients' perceptions of the care management will be evaluated by the Score at the rating scale (1 to 10) evaluating perceptions support to emergencies."}, {'measure': "Identification of patients'psychiatric underlying disorders", 'timeFrame': 'At 6 months', 'description': "The patients'psychiatric underlying disorders will be evaluated by Psychiatric diagnosis : criteria of ICD (International Classification of Diseases) 10"}, {'measure': 'Social and clinical evolution after the initial admission to emergency room', 'timeFrame': '6 months', 'description': 'The social evolution will be evaluated by social rupture, exclusion, penal measure and the clinical evolution will be evaluated by suicide attempt, disruptive behavior recurrence….'}, {'measure': 'Social and clinical evolution after the initial admission to emergency room', 'timeFrame': '12 months', 'description': 'The social evolution will be evaluated by social rupture, exclusion, penal measure and the clinical evolution will be evaluated by suicide attempt, disruptive behavior recurrence….'}, {'measure': 'Social and clinical evolution after the initial admission to emergency room', 'timeFrame': '24 months', 'description': 'The social evolution will be evaluated by social rupture, exclusion, penal measure and the clinical evolution will be evaluated by suicide attempt, disruptive behavior recurrence….'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Trajectory', 'Emergency room', 'Conduct disorder', 'Care management'], 'conditions': ['Disruptive Behavior']}, 'descriptionModule': {'briefSummary': 'Conduct disorders are defined as "repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate norms are violated". So defined, these disorders are at the crossroads of psychiatry, social field and justice. Conduct disorder management is a public health issue and a societal question. Conduct disorders affect 5 to 9% of 15-year old boys.\n\nCare management of children and adolescents admitted for disruptive behaviors in emergency rooms is an issue. No consensus or official recommendation exists. However, use of emergency care in this context is increasing in most western countries and it exposes to several risks (inappropriate use of hospitalizations, social rupture, ignorance of comorbidities and suicide risk). The Trajectories project is designed to describe children and adolescents with disruptive behaviors, their care management and to follow their life trajectory and psychiatric evolution after admission to emergency rooms. Better understanding this population will improve their medical and social care management, thereby giving professionals the right tools.\n\nThe main objective of this project is to implement a multidisciplinary and integrative research combining clinical considerations and social sciences to determine the "trajectory" of this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children and adolescents admitted to emergency rooms for aggressiveness, violence, fugue or theft\n\nExclusion Criteria:\n\n* Children and adolescents admitted to emergency rooms for a reason not directly link with aggressiveness, violence, fugue or theft\n* Opposition to the subject or the family to participate to this research'}, 'identificationModule': {'nctId': 'NCT02828969', 'acronym': 'TRAJECTORY', 'briefTitle': 'Clinical and Social Trajectory of Children and Adolescents With Disruptive Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Clinical Trajectory of Children and Adolescents With Disruptive Behavior Admitted to Pediatric and Psychiatric Emergencies.', 'orgStudyIdInfo': {'id': '69HCL16_0432'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Children and adolescents with conduct disorders', 'description': 'Girls and boys having less than 18 years old and admitted to emergency room for aggressiveness, violence, fugue or theft.', 'interventionNames': ['Other: Phone call or physical consultation']}], 'interventions': [{'name': 'Phone call or physical consultation', 'type': 'OTHER', 'armGroupLabels': ['Children and adolescents with conduct disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Lyon/bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Yannis GANSEL, MD', 'role': 'CONTACT', 'email': 'yannis.gansel@chu-lyon.fr', 'phone': '4.72.12.95.62', 'phoneExt': '+33'}, {'name': 'Sonia GALLETTI, CRA', 'role': 'CONTACT', 'email': 'sonia.galletti@chu-lyon.fr', 'phone': '427857739', 'phoneExt': '+33'}], 'facility': 'Hospices Civils de Lyon'}], 'centralContacts': [{'name': 'Yannis GANSEL, MD', 'role': 'CONTACT', 'email': 'yannis.gansel@chu-lyon.fr', 'phone': '4.72.12.95.62', 'phoneExt': '+33'}, {'name': 'Sonia GALETTI, CRA', 'role': 'CONTACT', 'email': 'sonia.galetti@chu-lyon.fr', 'phone': '427857739', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}