Back to resultsKIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
Primary Purpose
Post-Traumatic Stress Disorders
Status
Completed
Phase
Phase 3
Locations
Sri Lanka
Study Type
Interventional
Intervention
KIDNET
Meditation/Relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Post-Traumatic Stress Disorders focused on measuring PTSD, Depression, Suicidality, trauma-focussed treatment, KIDNET, Narrative Exposure Therapy for Children, Meditation, Relaxation, War
Eligibility Criteria
Inclusion Criteria:
- all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15
Exclusion Criteria:
- none
Sites / Locations
- University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
1 KIDNET
2 Meditation/Relaxation
3 KIDNET + Meditation/Relaxation
4 Meditation/Relaxation + KIDNET
Arm Description
Narrative Exposure Therapy for Children
mixed Meditation/Relaxation Protocol
KIDNET according to protocol, waiting time of 5 months, then Meditation/Relaxation according to protocol
Med/Relax according to protocol, 5 months waiting time, KIDNET according to protocol
Outcomes
Primary Outcome Measures
PTSD-Symptoms according to CAPS-CA (DSM-IV)
Secondary Outcome Measures
Depression score & Suicidality according to M.I.N.I. KID A and B
Full Information
NCT ID
NCT00564317
First Posted
November 26, 2007
Last Updated
November 26, 2007
Sponsor
University of Konstanz
Collaborators
NGO vivo e.V., GTZ-German Technical Cooperation, Germany, European Refugee Fund, German Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00564317
Brief Title
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
Official Title
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
Study Type
Interventional
2. Study Status
Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Konstanz
Collaborators
NGO vivo e.V., GTZ-German Technical Cooperation, Germany, European Refugee Fund, German Research Foundation
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 when applied by locally trained teacher counsellors as well as the effectiveness and adequacy of such a treatment in a south-asian war affected stayee child community.
Detailed Description
Outcome measures include PTSD symptom score, Depression score, Suicidal ideation and related functioning measures (including school grades)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorders
Keywords
PTSD, Depression, Suicidality, trauma-focussed treatment, KIDNET, Narrative Exposure Therapy for Children, Meditation, Relaxation, War
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 KIDNET
Arm Type
Experimental
Arm Description
Narrative Exposure Therapy for Children
Arm Title
2 Meditation/Relaxation
Arm Type
Experimental
Arm Description
mixed Meditation/Relaxation Protocol
Arm Title
3 KIDNET + Meditation/Relaxation
Arm Type
Experimental
Arm Description
KIDNET according to protocol, waiting time of 5 months, then Meditation/Relaxation according to protocol
Arm Title
4 Meditation/Relaxation + KIDNET
Arm Type
Experimental
Arm Description
Med/Relax according to protocol, 5 months waiting time, KIDNET according to protocol
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-Symptoms according to CAPS-CA (DSM-IV)
Time Frame
pre-test, 5-months, 14-months
Secondary Outcome Measure Information:
Title
Depression score & Suicidality according to M.I.N.I. KID A and B
Time Frame
pre-test, 5-months, 14-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15
Exclusion Criteria:
none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Rockstroh, Prof Dr
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Elisabeth Schauer, MA/MPH
Organizational Affiliation
University of Konstanz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka
City
Jaffna/Vallikamam
Country
Sri Lanka
12. IPD Sharing Statement
Links:
URL
http://www.vivo.org
Description
website of NGO which supported implementation in the field
Learn more about this trial
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
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