- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03498482
Adressing PTSD Symptoms and Aggressive Behavior in Vulnerable Children in Burundi
Treating Posttraumatic Stress Disorder and Reducing Aggressive Behavior in Street Children and Vulnerable Children in Burundi Using Narrative Exposure Therapy for Forensic Offender Rehabilitation.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bujumbura Mairie
-
Bujumbura, Bujumbura Mairie, Burundi
- vivo international & Psychologues sans Frontières mental health center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- High degree of symptoms of posttraumatic stress disorder according to UCLA PTSD Reaction Index
Exclusion Criteria:
- Psychotic symptoms
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
FORNET aims to reduce trauma-related symptoms and aggressive behavior via narrative exposure of traumatic and violent life events.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline; 5 months follow-up; 9 months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
baseline; 5 months follow-up; 9 months follow-up
|
Change of experienced shame measured via the Shame Variability Questionnaire
Time Frame: baseline; 5 months follow-up; 9 months follow-up
|
baseline; 5 months follow-up; 9 months follow-up
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKCR17
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Posttraumatic Stress Disorder
-
University Hospital, ToursCompletedPostTraumatic Stress DisorderFrance
-
The University of Texas Health Science Center at...University of Pennsylvania; Brooke Army Medical Center; C.R.Darnall Army Medical... and other collaboratorsCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Icahn School of Medicine at Mount SinaiCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Berlin Center for the Treatment of Torture VictimsCompletedPosttraumatic Stress Disorder (PTSD)Germany
-
TEMPVA Research Group, Inc.C.R.Darnall Army Medical Center; VA Boston Healthcare System; Central Texas Veterans...UnknownPosttraumatic Stress Disorder, Combat-relatedUnited States
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress Disorder (PTSD)United States
-
Michael E. DeBakey VA Medical CenterSouth Central VA Mental Illness Research, Education & Clinical CenterCompletedPosttraumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentCompletedPosttraumatic Stress Disorder (PTSD)United States
-
VA Office of Research and DevelopmentCompleted
-
Yale UniversityNational Center for PTSDCompletedPosttraumatic Stress Disorder (PTSD)United States
Clinical Trials on Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)
-
University of KonstanzWorld BankUnknownPost-traumatic Stress Disorder | Appetitive AggressionCongo
-
University of KonstanzVivo international e.V.; Psychologues sans Frontières Burundi; Action on Armed...CompletedAggression | Depression | Posttraumatic Stress DisorderBurundi
-
University of KonstanzCompletedAppetitive AggressionGermany
-
University of KonstanzCompletedPost-Traumatic Stress Disorder | Aggressive BehaviorBurundi
-
VA Office of Research and DevelopmentCompleted
-
University of NottinghamNottinghamshire Healthcare NHS Trust; Lincolnshire Partnership NHS Foundation...CompletedDomestic Violence | Trauma, Psychological | Post-Traumatic Stress Disorder in Children | Narrative Exposure Therapy | Post-Traumatic Stress Disorder in Adolescence | Post-Traumatic Stress Disorder ComplexUnited Kingdom
-
VA Office of Research and DevelopmentCompleted