Treatment of Formerly Abducted Children (FAC) in Uganda - Full Text View

Sponsor:	University of Konstanz
Collaborator:	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: Academic Counseling

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Further study details as provided by University of Konstanz:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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 [ Time Frame: 3 months, 6 months and 1 year after completion of treatment ] [ Designated as safety issue: No ]

Enrollment:	85
Study Start Date:	November 2007
Study Completion Date:	November 2009
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: NET	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. Other Name: NET
Active Comparator: AC	Behavioral: Academic Counseling 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 Name: AC
No Intervention: WL 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

Locations

Uganda
Vivo Counselling Centre
Anaka, Amuru, Uganda

Sponsors and Collaborators

University of Konstanz

German Research Foundation

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

More Information

No publications provided by University of Konstanz

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Prof.Dr. Frank Neuner, Bielefeld University
ClinicalTrials.gov Identifier:	NCT00552006 History of Changes
Other Study ID Numbers:	NE 1390/2-1
Study First Received:	October 31, 2007
Last Updated:	March 7, 2011
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

Additional relevant MeSH terms:

Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 12, 2012