The Efficacy of KIDNET in the Treatment of Traumatized Re... | NCT00559000

Studies
The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany

NCT00559000

Sponsor

University of Konstanz

Status

Completed

Last Update Posted

Nov 16, 2007Estimated

Enrollment

25Actual

Phase

Phase 3

Conditions

PTSD

Interventions

KIDNET

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Nov 15, 2007

First Submission Date that Met QC Criteria

Nov 15, 2007

First Posted Date

Nov 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2007

Last Update Posted Date

Nov 16, 2007Estimated

Name	Class
European Refugee Fund	OTHER
German Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Waitinglist Control	No Intervention
KIDNET	Experimental		Behavioral: KIDNET

Interventions

Name	Type	Description	Arm Group Labels	Other Names
KIDNET	Behavioral	Narrative Exposure Therapy for Children	KIDNET

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PTSD-Symptoms according to the UCLA Child PTSD INDEX		1-month, 6-months, 12-months

Secondary Outcomes

Measure	Description	Time Frame
Cognitive Performance according to SPM, CPM, Rey-Figure-Test, d2; Other mental health disorders according to M.I.N.I.-KID		6-months, 12-months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

refugee children
age range: 7-16
PTSD-Diagnosis

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas Elbert, Prof. Dr.	University of Konstanz	Principal Investigator
Martina Ruf, Dipl.-Psych.	University of Konstanz	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Konstanz, Research and Outpatient Clinic for Refugees		Reichenau-Lindenbühl		D-78479	Germany

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D013313	Stress Disorders, Post-Traumatic

Ancestor Terms

ID	Term
D040921	Stress Disorders, Traumatic
D000068099	Trauma and Stressor Related Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided