NCT03498482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
Last Updated

April 13, 2018

Status Verified

April 1, 2018

Enrollment Period

11 months

First QC Date

December 22, 2017

Last Update Submit

April 12, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

FORNET

EXPERIMENTAL

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)

Interventions

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

FORNET

Eligibility Criteria

Age8 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • Psychotic symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

vivo international & Psychologues sans Frontières mental health center

Bujumbura, Bujumbura Mairie Province, Burundi

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticAggression

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSocial Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 22, 2017

First Posted

April 13, 2018

Study Start

March 15, 2017

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

April 13, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations