{
  "FullStudy":{
    "Rank":217607,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01519193",
          "OrgStudyIdInfo":{
            "OrgStudyId":"UKCR2011"
          },
          "Organization":{
            "OrgFullName":"University of Konstanz",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder",
          "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"
        },
        "StatusModule":{
          "StatusVerifiedDate":"November 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 1, 2011",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"November 6, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 7, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Anselm Crombach",
            "ResponsiblePartyInvestigatorTitle":"Principal Investigator",
            "ResponsiblePartyInvestigatorAffiliation":"University of Konstanz"
          },
          "LeadSponsor":{
            "LeadSponsorName":"University of Konstanz",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "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."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Aggressive Behavior",
              "Post-Traumatic Stress Disorder"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Aggressive Behavior",
              "Appetitive Aggression",
              "Post-Traumatic Stress Disorder"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"42",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Narrative Exposure Therapy",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Behavioral: Narrative Exposure Therapy for violent offenders (NETvo)"
                  ]
                }
              },{
                "ArmGroupLabel":"No treatment control",
                "ArmGroupType":"No Intervention"
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Behavioral",
                "InterventionName":"Narrative Exposure Therapy for violent offenders (NETvo)",
                "InterventionDescription":"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.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Narrative Exposure Therapy"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)",
                "PrimaryOutcomeTimeFrame":"6 months"
              },{
                "PrimaryOutcomeMeasure":"Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)",
                "PrimaryOutcomeTimeFrame":"6 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Load of depressive symptoms measured via the MINI-KID",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Strength of suicidal ideation measured via the MINI-KID",
                "SecondaryOutcomeTimeFrame":"6 months"
              },{
                "SecondaryOutcomeMeasure":"Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)",
                "SecondaryOutcomeTimeFrame":"6 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPositive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS)\nchildren are part of an aid program for reintegration into society\n\nExclusion Criteria:\n\ncurrent substance dependance or use of antipsychotic drugs\nchronically ill children",
          "HealthyVolunteers":"No",
          "Gender":"Male",
          "MinimumAge":"12 Years",
          "MaximumAge":"23 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Anselm Crombach, Dipl.-Psych.",
                "OverallOfficialAffiliation":"University of Constance",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Fondation Stamm",
                "LocationCity":"Bujumbura",
                "LocationCountry":"Burundi"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000004194",
                "ConditionMeshTerm":"Disease"
              },{
                "ConditionMeshId":"D000040921",
                "ConditionMeshTerm":"Stress Disorders, Traumatic"
              },{
                "ConditionMeshId":"D000013313",
                "ConditionMeshTerm":"Stress Disorders, Post-Traumatic"
              },{
                "ConditionMeshId":"D000000374",
                "ConditionMeshTerm":"Aggression"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000068099",
                "ConditionAncestorTerm":"Trauma and Stressor Related Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              },{
                "ConditionAncestorId":"D000001526",
                "ConditionAncestorTerm":"Behavioral Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M23503",
                "ConditionBrowseLeafName":"Stress Disorders, Traumatic",
                "ConditionBrowseLeafAsFound":"Traumatic Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14686",
                "ConditionBrowseLeafName":"Stress Disorders, Post-Traumatic",
                "ConditionBrowseLeafAsFound":"Post Traumatic Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M2305",
                "ConditionBrowseLeafName":"Aggression",
                "ConditionBrowseLeafAsFound":"Aggressive Behavior",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M222",
                "ConditionBrowseLeafName":"Trauma and Stressor Related Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3399",
                "ConditionBrowseLeafName":"Behavioral Symptoms",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}