Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-02-21 @ 1:36 AM
Study NCT ID:
NCT01519193
Status:
COMPLETED
Last Update Posted:
2012-11-07
First Post:
2011-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000374', 'term': 'Aggression'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D000096762', 'term': 'Aberrant Motor Behavior in Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-06', 'studyFirstSubmitDate': '2011-12-01', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2012-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)', 'timeFrame': '6 months'}, {'measure': 'Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Load of depressive symptoms measured via the MINI-KID', 'timeFrame': '6 months'}, {'measure': 'Strength of suicidal ideation measured via the MINI-KID', 'timeFrame': '6 months'}, {'measure': "Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)", 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aggressive Behavior', 'Appetitive Aggression', 'Post-Traumatic Stress Disorder'], 'conditions': ['Aggressive Behavior', 'Post-Traumatic Stress Disorder']}, 'descriptionModule': {'briefSummary': 'Street children and children of vulnerable families in conflict or former conflict regions are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to foster successful reintegration into society.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Positive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS)\n* children are part of an aid program for reintegration into society\n\nExclusion Criteria:\n\n* current substance dependance or use of antipsychotic drugs\n* chronically ill children'}, 'identificationModule': {'nctId': 'NCT01519193', 'briefTitle': 'Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Konstanz'}, 'officialTitle': 'Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder in Former Street Children and Vulnerable Children in Burundi With Narrative Exposure Therapy for Violent Offenders', 'orgStudyIdInfo': {'id': 'UKCR2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Narrative Exposure Therapy', 'interventionNames': ['Behavioral: Narrative Exposure Therapy for violent offenders (NETvo)']}, {'type': 'NO_INTERVENTION', 'label': 'No treatment control'}], 'interventions': [{'name': 'Narrative Exposure Therapy for violent offenders (NETvo)', 'type': 'BEHAVIORAL', 'description': "During NETvo the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress and also on perpetrated violent acts. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. Positive emotions and cognitions reported for violent acts are linked to the respective past. During four sessions the most important traumatic experiences and perpetrated violent acts are processed. In the fifth session plans and ideas for the future are developed to assist the children to reintegrate themselves into society.", 'armGroupLabels': ['Narrative Exposure Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bujumbura', 'state': 'Bujumbura Mairie Province', 'country': 'Burundi', 'facility': 'Fondation Stamm', 'geoPoint': {'lat': -3.38193, 'lon': 29.36142}}], 'overallOfficials': [{'name': 'Anselm Crombach, Dipl.-Psych.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Constance'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Konstanz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anselm Crombach', 'investigatorAffiliation': 'University of Konstanz'}}}}