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

November 26, 2007 updated by: University of Konstanz
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sri Lanka
      • Jaffna/Vallikamam, Sri Lanka
        • University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PTSD-Symptoms according to CAPS-CA (DSM-IV)
Time Frame: pre-test, 5-months, 14-months
pre-test, 5-months, 14-months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Konstanz

Collaborators

German Research Foundation
NGO vivo e.V.
GTZ-German Technical Cooperation, Germany
European Refugee Fund

Investigators

  • Principal Investigator: Brigitte Rockstroh, Prof Dr, University of Konstanz
  • Principal Investigator: Elisabeth Schauer, MA/MPH, University of Konstanz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

November 26, 2007

First Submitted That Met QC Criteria

November 26, 2007

First Posted (Estimate)

November 27, 2007

Study Record Updates

Last Update Posted (Estimate)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mb/19.10.05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-Traumatic Stress Disorders

Clinical Trials on KIDNET

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe