PTSDPhase 3NCT00559000
The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany
A Phase 3 study testing KIDNET in people with PTSD, run by University of Konstanz at 1 site in Germany.
Trial summary
The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized refugee children in Germany Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- PTSD
- What is being tested?
- KIDNET
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2003to Apr 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 7 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- refugee children
- age range: 7-16
- PTSD-Diagnosis
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Konstanz, Research and Outpatient Clinic for Refugees
Reichenau-Lindenbühl, D-78479
About this study
The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized refugee children in Germany
- Conditions
- PTSD
- Being tested
- KIDNET
- Keywords
- PTSD, Children, trauma-focused Treatment, KIDNET, Narrative Exposure Therapy for Children
- 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
| Study group | Role | What they receive |
|---|---|---|
| Waitinglist Control | No intervention | Not described |
| KIDNET | Experimental | Not described Receives: Behavioral: KIDNET |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD-Symptoms according to the UCLA Child PTSD INDEX
Measured: 1-month, 6-months, 12-months
Secondary outcomes (1)
Cognitive Performance according to SPM, CPM, Rey-Figure-Test, d2; Other mental health disorders according to M.I.N.I.-KID
Measured: 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startDec 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Collaborators
- European Refugee Fund, German Research Foundation
- Investigators
- Thomas Elbert, Prof. Dr., Principal investigator, University of KonstanzMartina Ruf, Dipl.-Psych., Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00559000
- Sponsor's protocol ID
- mb
- Status last verified
- Nov 2007
- First submitted
- 15 Nov 2007
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany
- ClinicalTrials.gov ID
- NCT00559000
- Acronym / sponsor ID
- mb
- Conditions
- PTSD
- Keywords
- PTSD, Children, trauma-focused Treatment, KIDNET, Narrative Exposure Therapy for Children
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Collaborators
- European Refugee Fund, German Research Foundation
- Study start
- Dec 2003
- Study completion
- Apr 2006 (actual)
- First posted
- 16 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 the study is to assess the effectiveness of KIDNET in treating traumatized refugee children in Germany
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitinglist Control | No intervention | – |
| KIDNET | Experimental | Behavioral: KIDNET |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- refugee children
- age range: 7-16
- PTSD-Diagnosis
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 | Behavioural | KIDNET |
Primary outcome
PTSD-Symptoms according to the UCLA Child PTSD INDEX
Time frame: 1-month, 6-months, 12-months
1 secondary outcome
Cognitive Performance according to SPM, CPM, Rey-Figure-Test, d2; Other mental health disorders according to M.I.N.I.-KID
Time frame: 6-months, 12-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 16 Nov 2007.
- Related InfoLink 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.
Thomas Elbert, Prof. Dr. principal investigator
University of Konstanz
Martina Ruf, Dipl.-Psych. 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 in people with PTSD, run by University of Konstanz at 1 site in Germany.
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 3 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 16 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 Germany. 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 the UCLA Child PTSD INDEX (time frame: 1-month, 6-months, 12-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 16 Nov 2007.