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CompletedNCT03498482Updated Apr 13, 2018

Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi

An interventional study of Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET) in Posttraumatic Stress Disorder and Aggressive Behavior, sponsored by University of Konstanz. Completed at 1 site in Burundi. Open to participants aged 8 Years to 20 Years. Per ClinicalTrials.gov, last updated 2018-04-13.

Sponsored by University of Konstanz · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Mar 2017, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
8 Years to 20 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Posttraumatic Stress Disorder
  • Aggressive Behavior
03

In context

Stress Disorders, Post-Traumatic

2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.

This study's enrollment of 19 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

University of Konstanz is the lead sponsor of 51 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Psychotic symptoms
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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)

Interventions

  • BehavioralNarrative 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.

06

What researchers measure

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Change of experienced shame measured via the Shame Variability Questionnaire

    Time frame: baseline; 5 months follow-up; 9 months follow-up

07

Study locations

1 site
  • vivo international & Psychologues sans Frontières mental health center
    Bujumbura, Bujumbura Mairie, Burundi
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2017 to primary completion in Jan 2018, 10 months.

Of 1,064 non-industry interventional studies with no phase under Stress Disorders, Post-Traumatic, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's 10 months is below that.

Counting every sponsor, half of 1,092 studies reached it within 34 months; a quarter within 17 and three quarters within 53.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 22, 2017
First posted
Apr 13, 2018
StartActual
Mar 15, 2017
Primary completionActual
Jan 31, 2018
CompletionActual
Jan 31, 2018
Last update
Apr 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03498482
Lead sponsor
University of Konstanz
Collaborators
Vivo international e.V., Psychologues sans Frontières Burundi, Université Lumière de Bujumbura
Responsible party
Anselm Crombach (Principal investigator, University of Konstanz) — Principal investigator
First posted
Apr 13, 2018
Start date
Mar 15, 2017
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018
Last update
Apr 13, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.

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