Treatment of Formerly Abducted Children (FAC) in Uganda
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Narrative Exposure Therapy
Academic Counseling
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic focused on measuring PTSD, Treatment, Randomized Controlled Clinical Trial, Combat, Child Soldiers, Dissemination, Narrative Exposure Therapy, Africa
Eligibility 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
Sites / Locations
- Vivo Counselling Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
NET
AC
WL
Arm Description
Waiting list
Outcomes
Primary Outcome Measures
Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale)
Secondary Outcome Measures
Load of depressive symptoms measured via the MINI, strength of suicidal ideation measured via the MINI, functionality measured via the CAPS, feelings of guilt measured via the CAPS, stigmatization measured via an adapted version of the PSQ
Full Information
NCT ID
NCT00552006
First Posted
October 31, 2007
Last Updated
March 7, 2011
Sponsor
University of Konstanz
Collaborators
German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00552006
Brief Title
Treatment of Formerly Abducted Children (FAC) in Uganda
Official Title
A Randomized Controlled Clinical Trial (RCCT) to Test the Effectiveness of Narrative Exposure Therapy (NET) Versus an Attention Control Condition (AC) in Reducing Trauma Related Symptoms in Formerly Abducted Children and Former Child Soldiers Suffering From Posttraumatic Stress Disorder (PTSD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Konstanz
Collaborators
German Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
Keywords
PTSD, Treatment, Randomized Controlled Clinical Trial, Combat, Child Soldiers, Dissemination, Narrative Exposure Therapy, Africa
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NET
Arm Type
Experimental
Arm Title
AC
Arm Type
Active Comparator
Arm Title
WL
Arm Type
No Intervention
Arm Description
Waiting list
Intervention Type
Behavioral
Intervention Name(s)
Narrative Exposure Therapy
Other Intervention Name(s)
NET
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Academic Counseling
Other Intervention Name(s)
AC
Intervention Description
Missing time in educational life is one major issue for formerly abducted people. The Academic Counseling (AC) 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.
AC will be applied in eight sessions (90-120min/session) in a standardized, manualized manner.
Primary Outcome Measure Information:
Title
Load of traumatic symptoms measured via the CAPS (Clinician-administered PTSD scale)
Time Frame
3 months, 6 months and 1 year after completion of treatment
Secondary Outcome Measure Information:
Title
Load of depressive symptoms measured via the MINI, strength of suicidal ideation measured via the MINI, functionality measured via the CAPS, feelings of guilt measured via the CAPS, stigmatization measured via an adapted version of the PSQ
Time Frame
3 months, 6 months and 1 year after completion of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Neuner, Univ.-Prof. Dr.
Organizational Affiliation
Bielefeld University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Elbert, Univ.-Prof. Dr.
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Verena Ertl, Dipl.-Psych. (MSc)
Organizational Affiliation
Bielefeld University
Official's Role
Study Director
Facility Information:
Facility Name
Vivo Counselling Centre
City
Anaka
State/Province
Amuru
Country
Uganda
12. IPD Sharing Statement
Citations:
PubMed Identifier
21813428
Citation
Ertl V, Pfeiffer A, Schauer E, Elbert T, Neuner F. Community-implemented trauma therapy for former child soldiers in Northern Uganda: a randomized controlled trial. JAMA. 2011 Aug 3;306(5):503-12. doi: 10.1001/jama.2011.1060.
Results Reference
derived
Learn more about this trial
Treatment of Formerly Abducted Children (FAC) in Uganda
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