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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014