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

This study has been completed.
Sponsor:
Collaborators:
NGO vivo e.V.
GTZ-German Technical Cooperation, Germany
European Refugee Fund
German Research Foundation
Information provided by:
University of Konstanz
ClinicalTrials.gov Identifier:
NCT00564317
First received: November 26, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Post-Traumatic Stress Disorders
Behavioral: KIDNET
Behavioral: Meditation/Relaxation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka

Resource links provided by NLM:


Further study details as provided by University of Konstanz:

Primary Outcome Measures:
  • PTSD-Symptoms according to CAPS-CA (DSM-IV) [ Time Frame: pre-test, 5-months, 14-months ]

Secondary Outcome Measures:
  • Depression score & Suicidality according to M.I.N.I. KID A and B [ Time Frame: pre-test, 5-months, 14-months ]

Enrollment: 48
Study Start Date: September 2004
Study Completion Date: January 2006
Arms Assigned Interventions
Experimental: 1 KIDNET
Narrative Exposure Therapy for Children
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
Experimental: 2 Meditation/Relaxation
mixed Meditation/Relaxation Protocol
Behavioral: Meditation/Relaxation
a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
Experimental: 3 KIDNET + Meditation/Relaxation
KIDNET according to protocol, waiting time of 5 months, then Meditation/Relaxation according to protocol
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
Behavioral: Meditation/Relaxation
a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
Experimental: 4 Meditation/Relaxation + KIDNET
Med/Relax according to protocol, 5 months waiting time, KIDNET according to protocol
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
Behavioral: Meditation/Relaxation
a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   11 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564317

Locations
Sri Lanka
University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka
Jaffna/Vallikamam, Sri Lanka
Sponsors and Collaborators
University of Konstanz
NGO vivo e.V.
GTZ-German Technical Cooperation, Germany
European Refugee Fund
German Research Foundation
Investigators
Principal Investigator: Brigitte Rockstroh, Prof Dr University of Konstanz
Principal Investigator: Elisabeth Schauer, MA/MPH University of Konstanz
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00564317     History of Changes
Other Study ID Numbers: mb/19.10.05
Study First Received: November 26, 2007
Last Updated: November 26, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by University of Konstanz:
PTSD
Depression
Suicidality
trauma-focussed treatment
KIDNET
Narrative Exposure Therapy for Children
Meditation
Relaxation
War

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014