- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01519193
Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder
November 6, 2012 updated by: Anselm Crombach, University of Konstanz
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Bujumbura, Burundi
- Fondation Stamm
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 23 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Narrative Exposure Therapy
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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.
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No Intervention: No treatment control
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)
Time Frame: 6 months
|
6 months
|
Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)
Time Frame: 6 months
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6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Load of depressive symptoms measured via the MINI-KID
Time Frame: 6 months
|
6 months
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Strength of suicidal ideation measured via the MINI-KID
Time Frame: 6 months
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6 months
|
Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)
Time Frame: 6 months
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anselm Crombach, Dipl.-Psych., University of Constance
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
December 1, 2011
First Submitted That Met QC Criteria
January 23, 2012
First Posted (Estimate)
January 26, 2012
Study Record Updates
Last Update Posted (Estimate)
November 7, 2012
Last Update Submitted That Met QC Criteria
November 6, 2012
Last Verified
November 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKCR2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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