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

Sponsors and Collaborators:	University of Konstanz 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

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 III

MedlinePlus related topics: Depression Post-Traumatic Stress Disorder

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study
Official Title:	KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka

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
1 KIDNET: Experimental 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
2 Meditation/Relaxation: Experimental mixed Meditation/Relaxation Protocol	Behavioral: Meditation/Relaxation a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
3 KIDNET + Meditation/Relaxation: Experimental 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
4 Meditation/Relaxation + KIDNET: Experimental 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:

department website This link exits the ClinicalTrials.gov site

website of NGO which supported implementation in the field This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	mb/19.10.05
Study First Received:	November 26, 2007
Last Updated:	November 26, 2007
ClinicalTrials.gov Identifier:	NCT00564317 History of Changes
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

Study placed in the following topic categories:

Depression
Anxiety Disorders
Mental Disorders
Wounds and Injuries

Stress Disorders, Post-Traumatic
Stress
Depressive Disorder
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic

ClinicalTrials.gov processed this record on May 07, 2009