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Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder

Primary Purpose

Aggressive Behavior, Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 2
Locations
Burundi
Study Type
Interventional
Intervention
Narrative Exposure Therapy for violent offenders (NETvo)
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggressive Behavior focused on measuring Aggressive Behavior, Appetitive Aggression, Post-Traumatic Stress Disorder

Eligibility Criteria

12 Years - 23 Years (Child, Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Positive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS)
  • children are part of an aid program for reintegration into society

Exclusion Criteria:

  • current substance dependance or use of antipsychotic drugs
  • chronically ill children

Sites / Locations

  • Fondation Stamm

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Narrative Exposure Therapy

No treatment control

Arm Description

Outcomes

Primary Outcome Measures

Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)
Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)

Secondary Outcome Measures

Load of depressive symptoms measured via the MINI-KID
Strength of suicidal ideation measured via the MINI-KID
Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)

Full Information

First Posted
December 1, 2011
Last Updated
November 6, 2012
Sponsor
University of Konstanz
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1. Study Identification

Unique Protocol Identification Number
NCT01519193
Brief Title
Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Konstanz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Behavior, Post-Traumatic Stress Disorder
Keywords
Aggressive Behavior, Appetitive Aggression, Post-Traumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Narrative Exposure Therapy
Arm Type
Experimental
Arm Title
No treatment control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy for violent offenders (NETvo)
Intervention 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.
Primary Outcome Measure Information:
Title
Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)
Time Frame
6 months
Title
Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Load of depressive symptoms measured via the MINI-KID
Time Frame
6 months
Title
Strength of suicidal ideation measured via the MINI-KID
Time Frame
6 months
Title
Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
23 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS) children are part of an aid program for reintegration into society Exclusion Criteria: current substance dependance or use of antipsychotic drugs chronically ill children
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anselm Crombach, Dipl.-Psych.
Organizational Affiliation
University of Constance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation Stamm
City
Bujumbura
Country
Burundi

12. IPD Sharing Statement

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Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder

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