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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01519193
Other study ID # UKCR2011
Secondary ID
Status Completed
Phase Phase 2
First received December 1, 2011
Last updated November 6, 2012
Start date January 2011
Est. completion date May 2012

Study information

Verified date November 2012
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date May 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Male
Age group 12 Years to 23 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Behavioral:
Narrative Exposure Therapy for violent offenders (NETvo)
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.

Locations

Country Name City State
Burundi Fondation Stamm Bujumbura

Sponsors (1)

Lead Sponsor Collaborator
University of Konstanz

Country where clinical trial is conducted

Burundi, 

Outcome

Type Measure Description Time frame Safety issue
Primary Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students) 6 months No
Primary Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale) 6 months No
Secondary Load of depressive symptoms measured via the MINI-KID 6 months No
Secondary Strength of suicidal ideation measured via the MINI-KID 6 months No
Secondary Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire) 6 months No
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