NCT00820391

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2005

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
Last Updated

January 12, 2009

Status Verified

January 1, 2009

Enrollment Period

Same day

First QC Date

January 8, 2009

Last Update Submit

January 9, 2009

Conditions

Post-Traumatic Stress Disorder

Keywords

Post-traumatic Stress disorder (PTSD)

Outcome Measures

Primary Outcomes (1)

  • PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder

    pre-treatment, 1 month post, 6 months follow up

Secondary Outcomes (1)

  • Functioning, Somatic Problems, School grades

    pre, 1 month post, 6 months follow-up

Study Arms (2)

KIDNET

EXPERIMENTAL

Narrative Exposure Therapy for Children

Behavioral: KIDNET

Meditation/Relaxation

EXPERIMENTAL
Behavioral: Meditation-Relaxation

Interventions

KIDNETBEHAVIORAL

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

KIDNET
Meditation-RelaxationBEHAVIORAL

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

Meditation/Relaxation

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Mental retardation, psychosis, any neurological disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Catani C, Kohiladevy M, Ruf M, Schauer E, Elbert T, Neuner F. Treating children traumatized by war and Tsunami: a comparison between exposure therapy and meditation-relaxation in North-East Sri Lanka. BMC Psychiatry. 2009 May 13;9:22. doi: 10.1186/1471-244X-9-22.

    PMID: 19439099DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 8, 2009

First Posted

January 12, 2009

Study Start

January 1, 2005

Primary Completion

January 1, 2005

Study Completion

October 1, 2005

Last Updated

January 12, 2009

Record last verified: 2009-01