KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2004
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
November 26, 2007
CompletedFirst Posted
Study publicly available on registry
November 27, 2007
CompletedNovember 27, 2007
November 1, 2007
November 26, 2007
November 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD-Symptoms according to CAPS-CA (DSM-IV)
pre-test, 5-months, 14-months
Secondary Outcomes (1)
Depression score & Suicidality according to M.I.N.I. KID A and B
pre-test, 5-months, 14-months
Study Arms (4)
1 KIDNET
EXPERIMENTALNarrative Exposure Therapy for Children
2 Meditation/Relaxation
EXPERIMENTALmixed Meditation/Relaxation Protocol
3 KIDNET + Meditation/Relaxation
EXPERIMENTALKIDNET according to protocol, waiting time of 5 months, then Meditation/Relaxation according to protocol
4 Meditation/Relaxation + KIDNET
EXPERIMENTALMed/Relax according to protocol, 5 months waiting time, KIDNET according to protocol
Interventions
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
a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
Eligibility Criteria
You may qualify if:
- all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Konstanzlead
- NGO vivo e.V.collaborator
- GTZ-German Technical Cooperation, Germanycollaborator
- European Refugee Fundcollaborator
- German Research Foundationcollaborator
Study Sites (1)
University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka
Jaffna/Vallikamam, Sri Lanka
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brigitte Rockstroh, Prof Dr
University of Konstanz
- PRINCIPAL INVESTIGATOR
Elisabeth Schauer, MA/MPH
University of Konstanz
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 26, 2007
First Posted
November 27, 2007
Study Start
September 1, 2004
Study Completion
January 1, 2006
Last Updated
November 27, 2007
Record last verified: 2007-11