- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00552006
Treatment of Formerly Abducted Children (FAC) in Uganda
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Amuru
-
Anaka, Amuru, Uganda
- Vivo Counselling Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: NET
|
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.
Other Names:
|
|
Active Comparator: AC
|
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.
Other Names:
|
|
No Intervention: WL
Waiting list
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 months, 6 months and 1 year after completion of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 months, 6 months and 1 year after completion of treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Frank Neuner, Univ.-Prof. Dr., Bielefeld University
- Principal Investigator: Thomas Elbert, Univ.-Prof. Dr., University of Konstanz
- Study Director: Verena Ertl, Dipl.-Psych. (MSc), Bielefeld University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NE 1390/2-1
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.
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