Post-Traumatic Stress DisordersPhase 3NCT00564317
KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
A Phase 3 study testing KIDNET and Meditation/Relaxation in people with Post-Traumatic Stress Disorders, run by University of Konstanz at 1 site in Sri Lanka.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 15 years
- Conditions the study is for
- Post-Traumatic Stress Disorders
- 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
- 48 participants
- Where
- 1 siteSri Lanka
- Study dates
- Sep 2004to Jan 2006
- 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 11 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site
University of Konstanz/vivo e.V. Germany & Vallikamam/Jaffna Educational Zones, Sri Lanka
Jaffna/Vallikamam
About this study
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.
Read the detailed description
Outcome measures include PTSD symptom score, Depression score, Suicidal ideation and related functioning measures (including school grades)
- Conditions
- Post-Traumatic Stress Disorders
- Being tested
- KIDNET, Meditation/Relaxation
- Keywords
- PTSD, Depression, Suicidality, trauma-focussed treatment, KIDNET, Narrative Exposure Therapy for Children, Meditation, Relaxation, War
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Suicidal Ideation
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 |
|---|---|---|
| 1 KIDNET | Experimental | Narrative Exposure Therapy for Children Receives: Behavioral: KIDNET |
| 2 Meditation/Relaxation | Experimental | mixed Meditation/Relaxation Protocol Receives: Behavioral: Meditation/Relaxation |
| 3 KIDNET + Meditation/Relaxation | Experimental | KIDNET according to protocol, waiting time of 5 months, then Meditation/Relaxation according to protocol Receives: Behavioral: KIDNET; Behavioral: Meditation/Relaxation |
| 4 Meditation/Relaxation + KIDNET | Experimental | Med/Relax according to protocol, 5 months waiting time, KIDNET according to protocol Receives: Behavioral: KIDNET; Behavioral: Meditation/Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD-Symptoms according to CAPS-CA (DSM-IV)
Measured: pre-test, 5-months, 14-months
Secondary outcomes (1)
Depression score & Suicidality according to M.I.N.I. KID A and B
Measured: pre-test, 5-months, 14-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2007 (estimated)
- Study startSep 2004
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress DisordersStudies 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
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 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, Germany, European Refugee Fund, German Research Foundation
- Investigators
- Brigitte Rockstroh, Prof Dr, Principal investigator, University of KonstanzElisabeth Schauer, MA/MPH, Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00564317
- Sponsor's protocol ID
- mb/19.10.05
- Status last verified
- Nov 2007
- First submitted
- 26 Nov 2007
- Last updated
- 27 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KIDNET vs Meditation/Relaxation - a Dissemination Randomized Controlled Trial for the Treatment of Traumatized Children After War in Sri Lanka
- ClinicalTrials.gov ID
- NCT00564317
- Acronym / sponsor ID
- mb/19.10.05
- Conditions
- Post-Traumatic Stress Disorders
- Keywords
- PTSD, Depression, Suicidality, trauma-focussed treatment, KIDNET, Narrative Exposure Therapy for Children, Meditation, Relaxation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- NGO vivo e.V., GTZ-German Technical Cooperation, Germany, European Refugee Fund, German Research Foundation
- Study start
- Sep 2004
- Study completion
- Jan 2006 (actual)
- First posted
- 27 Nov 2007 (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 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.
Detailed description
Outcome measures include PTSD symptom score, Depression score, Suicidal ideation and related functioning measures (including school grades)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 KIDNET | Experimental | Behavioral: KIDNETNarrative Exposure Therapy for Children |
| 2 Meditation/Relaxation | Experimental | Behavioral: Meditation/Relaxationmixed Meditation/Relaxation Protocol |
| 3 KIDNET + Meditation/Relaxation | Experimental | Behavioral: KIDNET, Behavioral: Meditation/RelaxationKIDNET according to protocol, waiting time of 5 months, then Meditation/Relaxation according to protocol |
| 4 Meditation/Relaxation + KIDNET | Experimental | Behavioral: KIDNET, Behavioral: Meditation/RelaxationMed/Relax according to protocol, 5 months waiting time, KIDNET according to protocol |
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all children with PTSD Diagnosis from six surveyed schools in Vallikamam/Jaffna educational zones age range 11-15
Key exclusion criteria (1 listed)
- none
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 | 1 KIDNET, 3 KIDNET + Meditation/Relaxation, 4 Meditation/Relaxation + KIDNET |
| Meditation/Relaxationa protocol of traditional/local meditation and relaxation exercises, such as breathing meditation, chanting, body relaxation | Behavioural | 2 Meditation/Relaxation, 3 KIDNET + Meditation/Relaxation, 4 Meditation/Relaxation + KIDNET |
Primary outcome
PTSD-Symptoms according to CAPS-CA (DSM-IV)
Time frame: pre-test, 5-months, 14-months
1 secondary outcome
Depression score & Suicidality according to M.I.N.I. KID A and B
Time frame: pre-test, 5-months, 14-months
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 27 Nov 2007.
- website of NGO which supported implementation in the fieldLink provided by the sponsor.
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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.
Brigitte Rockstroh, Prof Dr principal investigator
University of Konstanz
Elisabeth Schauer, MA/MPH principal investigator
University of Konstanz
1 site in 1 country: see every site and its status.
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 Disorders, run by University of Konstanz at 1 site in Sri Lanka.
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 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
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-Symptoms according to CAPS-CA (DSM-IV) (time frame: pre-test, 5-months, 14-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2007.