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KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami

Primary Purpose

Post-Traumatic Stress Disorder

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
KIDNET
Meditation-Relaxation
Sponsored by
University of Konstanz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder focused on measuring Post-traumatic Stress disorder (PTSD)

Eligibility Criteria

8 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children with preliminary PTSD diagnosis (except for time criterion) in the age range of 8 to 14 years living in a specific IDP camp after the Tsunami disaster.

Exclusion Criteria:

  • Mental retardation, psychosis, any neurological disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    KIDNET

    Meditation/Relaxation

    Arm Description

    Narrative Exposure Therapy for Children

    Outcomes

    Primary Outcome Measures

    PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder

    Secondary Outcome Measures

    Functioning, Somatic Problems, School grades

    Full Information

    First Posted
    January 8, 2009
    Last Updated
    January 9, 2009
    Sponsor
    University of Konstanz
    Collaborators
    NGO vivo e.V., GTZ-German Technical Cooperation, rmany, German Research Foundation, Ein Herz für Kinder
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00820391
    Brief Title
    KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami
    Official Title
    KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Treatment Trial for Children in Sri Lanka Traumatized by the War and the Tsunami
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    January 2005 (Actual)
    Study Completion Date
    October 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Konstanz
    Collaborators
    NGO vivo e.V., GTZ-German Technical Cooperation, rmany, German Research Foundation, Ein Herz für Kinder

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children in Sri Lanka when applied by locally trained teacher counsellors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post-Traumatic Stress Disorder
    Keywords
    Post-traumatic Stress disorder (PTSD)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    31 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    KIDNET
    Arm Type
    Experimental
    Arm Description
    Narrative Exposure Therapy for Children
    Arm Title
    Meditation/Relaxation
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    KIDNET
    Intervention Description
    Narrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events
    Intervention Type
    Behavioral
    Intervention Name(s)
    Meditation-Relaxation
    Intervention Description
    a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
    Primary Outcome Measure Information:
    Title
    PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder
    Time Frame
    pre-treatment, 1 month post, 6 months follow up
    Secondary Outcome Measure Information:
    Title
    Functioning, Somatic Problems, School grades
    Time Frame
    pre, 1 month post, 6 months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children with preliminary PTSD diagnosis (except for time criterion) in the age range of 8 to 14 years living in a specific IDP camp after the Tsunami disaster. Exclusion Criteria: Mental retardation, psychosis, any neurological disorder

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19439099
    Citation
    Catani C, Kohiladevy M, Ruf M, Schauer E, Elbert T, Neuner F. Treating children traumatized by war and Tsunami: a comparison between exposure therapy and meditation-relaxation in North-East Sri Lanka. BMC Psychiatry. 2009 May 13;9:22. doi: 10.1186/1471-244X-9-22.
    Results Reference
    derived

    Learn more about this trial

    KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami

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