Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-26 @ 3:17 AM
Study NCT ID:
NCT02524535
Status:
COMPLETED
Last Update Posted:
2015-08-14
First Post:
2015-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alliance With Therapeutic Entourage in Support of Young Suicidal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078462', 'term': 'Therapeutic Alliance'}], 'ancestors': [{'id': 'D013811', 'term': 'Psychotherapeutic Processes'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 292}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'lastUpdateSubmitDate': '2015-08-13', 'studyFirstSubmitDate': '2015-08-13', 'studyFirstSubmitQcDate': '2015-08-13', 'lastUpdatePostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'characteristics of the mobilization of the entourage evaluated with Family Assessment Device', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Suicide']}, 'descriptionModule': {'briefSummary': 'Regardless of age, the quality of hospital care, the confidence that the young can have in the health care team, joining parents are pivotal elements and influence followed. Family support is all the more important as 14% of young people realize a new suicidal act within three months of hospitalization for attempted suicide, and that the essential predictors appear to be the young age and quality of intra-family relationships.\n\nThe main objective of this study is to determine, through the construction of an instrument to quantify the therapeutic alliance, defined by the characteristics of the mobilization of the entourage and the mutual commitments in the care of nursing teams and the entourage, the role of early therapeutic alliance with the entourage of suicidal youth 13-40 years, whether primosuicidants or repeat offenders, on short and medium term recurrences and early mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged 13-40 years\n* From male or female\n* Supported the waning of a suicidal gesture.\n* speaking and writing fluent French\n* living in Upper or Lower Normandy\n* signed informed consent form, and at least one of his parents after oral and written information about the study for minors.\n\nExclusion Criteria:\n\n* Age \\<13 years or \\> 40 years\n* Do not live in the Upper and Lower Normandy regions\n* Detained patient\n* forced hospitalization\n* Patient under guardianship\n* Patient with severe somatic pathology (cancer, heart failure, kidney or respiratory, central neurological disorder), scalable, or likely to be life-threatening within a period of less than one year\n* Refusal to participate in the study\n* Inability to respond'}, 'identificationModule': {'nctId': 'NCT02524535', 'acronym': 'IPSI2', 'briefTitle': 'Alliance With Therapeutic Entourage in Support of Young Suicidal', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Caen'}, 'orgStudyIdInfo': {'id': '06-088'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Therapetic alliance', 'interventionNames': ['Other: Therapeutic alliance']}], 'interventions': [{'name': 'Therapeutic alliance', 'type': 'OTHER', 'armGroupLabels': ['Therapetic alliance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14000', 'city': 'Caen', 'country': 'France', 'facility': 'service de pédopsychiatrie, CHU de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Caen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}