ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00564317
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : November 27, 2007
Sponsor:
Collaborators:
NGO vivo e.V.
GTZ-German Technical Cooperation, Germany
European Refugee Fund
German Research Foundation
Information provided by:
University of Konstanz

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.

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : September 2004
Actual Study Completion Date : January 2006

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   11 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
ClinicalTrials.gov Identifier: NCT00564317     History of Changes
Other Study ID Numbers: mb/19.10.05
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: November 27, 2007
Last Verified: November 2007

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, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders