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

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

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

ClinicalTrials.gov processed this record on January 15, 2009