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Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi

Primary Purpose

Posttraumatic Stress Disorder, Aggressive Behavior

Status

Completed

Phase

Not Applicable

Locations

Burundi

Study Type

Interventional

Intervention

Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder

Eligibility Criteria

8 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

High degree of symptoms of posttraumatic stress disorder according to UCLA PTSD Reaction Index

Exclusion Criteria:

Psychotic symptoms

Sites / Locations

vivo international & Psychologues sans Frontières mental health center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FORNET

Arm Description

During FORNET, the client, with the assistance of the therapist, constructs a chronological narrative of his or her entire life with a focus on exposure to traumatic stress and committed violence. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior. The therapist asks in detail for the client's emotions, cognitions, physiological reactions, and sensory informations during traumatic and aggressive events to link them to an autobiographical context, namely time and place. In total the individuals receive 8 sessions of FORNET, every session lasting between 1.5 and 2 hours depending on the needs of the participant.

Outcomes

Primary Outcome Measures

Change of load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (PTSD scale administered by Clinicians)

Secondary Outcome Measures

Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist

Change of experienced shame measured via the Shame Variability Questionnaire

Full Information

NCT ID

NCT03498482

First Posted

December 22, 2017

Last Updated

April 12, 2018

Sponsor

University of Konstanz

Collaborators

Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura

1. Study Identification

Unique Protocol Identification Number

NCT03498482

Brief Title

Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi

Official Title

Treating Posttraumatic Stress Disorder and Reducing Aggressive Behavior in Street Children and Vulnerable Children in Burundi Using Narrative Exposure Therapy for Forensic Offender Rehabilitation.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

March 15, 2017 (Actual)

Primary Completion Date

January 31, 2018 (Actual)

Study Completion Date

January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Konstanz

Collaborators

Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Children either living in the streets of Bujumbara or that are similarly affected by extreme poverty or violence are regularly exposed to traumatic events. Additionally, they often find themselves in situations where engaging in violent behavior appears to be useful or even necessary for survival. The Narrative Exposure Therapy for violent offenders (FORNET) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and potential positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to enable reintegration into the family. The investigators want to provide evidence, that FORNET effectively reduces PTSD symptoms and ongoing aggressive behavior which in change facilitates reintegration into society.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posttraumatic Stress Disorder, Aggressive Behavior

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FORNET

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)

Intervention Description

FORNET aims to reduce trauma-related symptoms and aggressive behavior via narrative exposure of traumatic and violent life events.

Primary Outcome Measure Information:

Title

Change of load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (PTSD scale administered by Clinicians)

Time Frame

baseline; 5 months follow-up; 9 months follow-up

Secondary Outcome Measure Information:

Title

Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist

Time Frame

baseline; 5 months follow-up; 9 months follow-up

Title

Change of experienced shame measured via the Shame Variability Questionnaire

Time Frame

baseline; 5 months follow-up; 9 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: High degree of symptoms of posttraumatic stress disorder according to UCLA PTSD Reaction Index Exclusion Criteria: Psychotic symptoms

Facility Information:

Facility Name

vivo international & Psychologues sans Frontières mental health center

City

Bujumbura

State/Province

Bujumbura Mairie

Country

Burundi

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi

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