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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820391
• Other study ID #: KIDNET2005
• Status: Completed
• Phase: Phase 3
• First received: January 8, 2009
• Last updated: January 9, 2009
• Start date: January 2005
• Est. completion date: October 2005

Study information

• Verified date: January 2009
• Source: University of Konstanz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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
• Meditation-Relaxation
a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
University of Konstanz	Ein Herz für Kinder, German Research Foundation, GTZ-German Technical Cooperation, rmany, NGO vivo e.V.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder		pre-treatment, 1 month post, 6 months follow up	No
Secondary	Functioning, Somatic Problems, School grades		pre, 1 month post, 6 months follow-up	No