KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami

January 9, 2009 updated by: University of Konstanz

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

The purpose of this study is to assess the efficacy of KIDNET versus a Meditation/Relaxation protocol in treating traumatized children in Sri Lanka when applied by locally trained teacher counsellors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 3

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

8 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with preliminary PTSD diagnosis (except for time criterion) in the age range of 8 to 14 years living in a specific IDP camp after the Tsunami disaster.

Exclusion Criteria:

  • Mental retardation, psychosis, any neurological disorder

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
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: Meditation/Relaxation
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 Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder
Time Frame: pre-treatment, 1 month post, 6 months follow up
pre-treatment, 1 month post, 6 months follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Functioning, Somatic Problems, School grades
Time Frame: pre, 1 month post, 6 months follow-up
pre, 1 month post, 6 months follow-up

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, rmany
Ein Herz für Kinder

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.

General Publications

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

January 1, 2005

Primary Completion (Actual)

January 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 9, 2009

First Posted (Estimate)

January 12, 2009

Study Record Updates

Last Update Posted (Estimate)

January 12, 2009

Last Update Submitted That Met QC Criteria

January 9, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KIDNET2005

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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