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NCT00564317 Clinical Trial

KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka

Post-Traumatic Stress Disorders Clinical Trial

Official title:
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00564317
Other study ID # mb/19.10.05
Secondary ID
Status Completed
Phase Phase 3
First received November 26, 2007
Last updated November 26, 2007
Start date September 2004
Est. completion date January 2006

Study information
Verified date November 2007
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Description:

Outcome measures include PTSD symptom score, Depression score, Suicidal ideation and related functioning measures (including school grades)

Recruitment information / eligibility
Status Completed
Enrollment 48
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 15 Years
Eligibility Inclusion Criteria:

- all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• KIDNET
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
• Meditation/Relaxation
a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation

Locations
Country Name City State
Sri Lanka University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka Jaffna/Vallikamam

Sponsors (5)
Lead Sponsor Collaborator
University of Konstanz European Refugee Fund, German Research Foundation, GTZ-German Technical Cooperation, Germany, NGO vivo e.V.

Country where clinical trial is conducted

Sri Lanka, 

Outcome
Type Measure Description Time frame Safety issue
Primary PTSD-Symptoms according to CAPS-CA (DSM-IV) pre-test, 5-months, 14-months
Secondary Depression score & Suicidality according to M.I.N.I. KID A and B pre-test, 5-months, 14-months
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