Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi

Sponsor

University of Konstanz (Other)

Overall Status

Completed

CT.gov ID

NCT03498482

Collaborator

Vivo international e.V. (Industry), Psychologues sans Frontières Burundi (Other), Université Lumière de Bujumbura (Other)

Enrollment

Location

Arm

10.6

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Aggressive Behavior	Behavioral: Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

19 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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.

Actual Study Start Date :

Mar 15, 2017

Actual Primary Completion Date :

Jan 31, 2018

Actual Study Completion Date :

Jan 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FORNET 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.	Behavioral: Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) FORNET aims to reduce trauma-related symptoms and aggressive behavior via narrative exposure of traumatic and violent life events.

Arm

Intervention/Treatment

Experimental: FORNET

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.

Behavioral: Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)

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

Outcome Measures

Primary Outcome Measures

Change of load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (PTSD scale administered by Clinicians) [baseline; 5 months follow-up; 9 months follow-up]

Secondary Outcome Measures

Change of number of aggressive acts measured via an adaption of the Domestic and Community Violence Checklist [baseline; 5 months follow-up; 9 months follow-up]
Change of experienced shame measured via the Shame Variability Questionnaire [baseline; 5 months follow-up; 9 months follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 20 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Psychotic symptoms

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	vivo international & Psychologues sans Frontières mental health center	Bujumbura	Bujumbura Mairie	Burundi

Sponsors and Collaborators

University of Konstanz
Vivo international e.V.
Psychologues sans Frontières Burundi
Université Lumière de Bujumbura

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Anselm Crombach, Principal investigator, University of Konstanz

ClinicalTrials.gov Identifier:

NCT03498482

Other Study ID Numbers:

UKCR17

First Posted:

Apr 13, 2018

Last Update Posted:

Apr 13, 2018

Last Verified:

Apr 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Aggression

Study Results

No Results Posted as of Apr 13, 2018