NCT00559000

Brief Summary

The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized refugee children in Germany

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

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

December 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 16, 2007

Completed
Last Updated

November 16, 2007

Status Verified

November 1, 2007

First QC Date

November 15, 2007

Last Update Submit

November 15, 2007

Conditions

PTSD

Keywords

PTSDChildrentrauma-focused TreatmentKIDNETNarrative Exposure Therapy for Children

Outcome Measures

Primary Outcomes (1)

  • PTSD-Symptoms according to the UCLA Child PTSD INDEX

    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

    6-months, 12-months

Study Arms (2)

Waitinglist Control

NO INTERVENTION

KIDNET

EXPERIMENTAL
Behavioral: KIDNET

Interventions

KIDNETBEHAVIORAL

Narrative Exposure Therapy for Children

KIDNET

Eligibility Criteria

Age7 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • refugee children
  • age range: 7-16
  • PTSD-Diagnosis

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz, Research and Outpatient Clinic for Refugees

Reichenau-Lindenbühl, D-78479, Germany

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Thomas Elbert, Prof. Dr.

    University of Konstanz

    PRINCIPAL INVESTIGATOR

  • Martina Ruf, Dipl.-Psych.

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 15, 2007

First Posted

November 16, 2007

Study Start

December 1, 2003

Study Completion

April 1, 2006

Last Updated

November 16, 2007

Record last verified: 2007-11

Locations

DE(1)