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Treatment of Formerly Abducted Children (FAC) in Uganda

This study is currently recruiting participants.
Verified by University of Konstanz, July 2008

Sponsors and Collaborators: University of Konstanz
German Research Foundation
Information provided by: University of Konstanz
ClinicalTrials.gov Identifier: NCT00552006
  Purpose

In the aftermath of traumatic experiences like natural disasters or man-caused traumatic events, such as war experiences, a substantial part of the affected individuals develop a number of psychological symptoms. The characteristic symptom pattern occurring in the aftermath of traumatic events is called posttraumatic stress disorder (PTSD) and includes functional impairment of the affected individuals. The investigators want to test whether Narrative Exposure Therapy (NET) is an effective tool in reducing trauma related symptoms in formerly abducted children and youths and former child soldiers, when applied by lay personnel.


Condition Intervention
Stress Disorders, Post-Traumatic
Behavioral: Narrative Exposure Therapy
Behavioral: English Control

MedlinePlus related topics:   Injuries    Post-Traumatic Stress Disorder    Stress    Wounds   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title:   A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (EC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)

Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • Load of traumatic symptoms measured via the PDS (Posttraumatic Diagnostic Scale) and the CAPS (Clinician-administered PTSD scale) [ Time Frame: 3 months, 6 months and 1 year after completion of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Load of depressive symptoms measured via the HSCL, strength of suicidal ideation measured via the MINI, functionality measured via an adapted functionality scale, aggressiveness measured via an adapted version of the Aggression Questionnaire [ Time Frame: 3 months, 6 months and 1 year after completion of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:   60
Study Start Date:   November 2007
Estimated Study Completion Date:   September 2009
Estimated Primary Completion Date:   September 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
NET: Experimental Behavioral: Narrative Exposure Therapy

Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. In cooperation with the therapist the clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography.

NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.

EC: Active Comparator Behavioral: English Control

Missing time in educational life is one major issue for formerly abducted people. The English Control (EC) intervention is an active Control condition and improves English skills and works at the same time on concentration, learning and memory abilities. The clients will gain some of the abilities and skills they might have lost or developed weaknesses in due to their abduction.

EC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.

WL: No Intervention
Waiting list

  Eligibility
Ages Eligible for Study:   12 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • clinical diagnosis of PTSD (Post-Traumatic Stress Disorder) derived from expert interviews
  • member of the group of formerly abducted people or former child soldiers

Exclusion Criteria:

  • current substance dependence
  • mental retardation
  • psychotic disorder
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552006

Contacts
Contact: Verena Ertl, Dipl.-Psych. (MSc)     +49 7531 88 4250     Verena.Ertl@uni-konstanz.de    
Contact: Frank Neuner, Jun.-Prof. Dr.     +49 7531 88 4621     Frank.Neuner@uni-konstanz.de    

Locations
Uganda, Amuru
Vivo Counselling Centre     Recruiting
      Anaka, Amuru, Uganda
      Contact: Frank Neuner, Prof.Dr.     +49 7531 884621     frank.neuner@uni-konstanz.de    
      Contact: Verena E. Ertl, Dipl.-Psych. (MSc)     +49 7531 884250     verena.ertl@uni-konstanz.de    
      Principal Investigator: Frank Neuner, Prof.Dr.            

Sponsors and Collaborators
University of Konstanz
German Research Foundation

Investigators
Principal Investigator:     Frank Neuner, Jun.-Prof. Dr.     University of Konstanz    
Principal Investigator:     Thomas Elbert, Univ.-Prof. Dr.     University of Konstanz    
Study Director:     Verena Ertl, Dipl.-Psych. (MSc)     University of Konstanz    
  More Information


Responsible Party:   University of Konstanz ( Prof.Dr. Frank Neuner )
Study ID Numbers:   NE 1390/2-1
First Received:   October 31, 2007
Last Updated:   July 17, 2008
ClinicalTrials.gov Identifier:   NCT00552006
Health Authority:   Germany: Ethics Commission

Keywords provided by University of Konstanz:
PTSD  
Treatment  
Randomized Controlled Clinical Trial  
Combat  
Child Soldiers
Dissemination
Narrative Exposure Therapy
Africa

Study placed in the following topic categories:
Anxiety Disorders
Mental Disorders
Wounds and Injuries
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:
Pathologic Processes
Disease

ClinicalTrials.gov processed this record on October 07, 2008




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