Post-Traumatic Stress DisorderPhase 3NCT00820391
KIDNET Versus Meditation/Relaxation - a Dissemination RCTT for Children in Sri Lanka Traumatized by the War and the Tsunami
A Phase 3 study testing KIDNET and Meditation-Relaxation in people with Post-Traumatic Stress Disorder, run by University of Konstanz.
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. Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- KIDNET and Meditation-Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Jan 2005to Oct 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Mental retardation, psychosis, any neurological disorder
About this study
Official title: KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Treatment Trial for Children in Sri Lanka Traumatized by the War and the Tsunami
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.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- KIDNET, Meditation-Relaxation
- Keywords
- Post-traumatic Stress disorder (PTSD)
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KIDNETBehavioural
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-RelaxationBehavioural
a protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation
| Study group | Role | What they receive |
|---|---|---|
| KIDNET | Experimental | Narrative Exposure Therapy for Children Receives: Behavioral: KIDNET |
| Meditation/Relaxation | Experimental | Not described Receives: Behavioral: Meditation-Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder
Measured: pre-treatment, 1 month post, 6 months follow up
Secondary outcomes (1)
Functioning, Somatic Problems, School grades
Measured: pre, 1 month post, 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startJan 2005
- Primary completionJan 2005
- Study completionOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- NGO vivo e.V., GTZ-German Technical Cooperation, rmany, German Research Foundation, Ein Herz für Kinder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00820391
- Sponsor's protocol ID
- KIDNET2005
- Status last verified
- Jan 2009
- First submitted
- 8 Jan 2009
- Last updated
- 12 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19439099
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Treatment Trial for Children in Sri Lanka Traumatized by the War and the Tsunami
- ClinicalTrials.gov ID
- NCT00820391
- Acronym / sponsor ID
- KIDNET2005
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Post-traumatic Stress disorder (PTSD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- NGO vivo e.V., GTZ-German Technical Cooperation, rmany, German Research Foundation, Ein Herz für Kinder
- Study start
- Jan 2005
- Primary completion
- Jan 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 12 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KIDNET | Experimental | Behavioral: KIDNETNarrative Exposure Therapy for Children |
| Meditation/Relaxation | Experimental | Behavioral: Meditation-Relaxation |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Mental retardation, psychosis, any neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KIDNETNarrative Exposure Therapy for Children - a short term intervention for the treatment of trauma after war, organized violence, torture, abuse and other detrimental life events | Behavioural | KIDNET |
| Meditation-Relaxationa protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation | Behavioural | Meditation/Relaxation |
Primary outcome
PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder
Time frame: pre-treatment, 1 month post, 6 months follow up
1 secondary outcome
Functioning, Somatic Problems, School grades
Time frame: pre, 1 month post, 6 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2009.
- Derived from this study: PubMed 19439099Catani 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.
Related trials for Post-Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing KIDNET and Meditation-Relaxation in people with Post-Traumatic Stress Disorder, run by University of Konstanz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD Symptom Severity according to UPID; DSM IV Diagnosis of Posttraumatic Stress disorder (time frame: pre-treatment, 1 month post, 6 months follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00820391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2009.