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Psychological Prevention of Internalizing Disorders
This study is currently recruiting participants.
Verified by Philipps University Marburg Medical Center, May 2008
Sponsors and Collaborators: Philipps University Marburg Medical Center
Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg
Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
Information provided by: Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00564239
  Purpose

The purpose of this study is to determine whether cognitive-behavioral group prevention (CBT-G) for german children is effective and to what extent parental group training moderates outcome.


Condition Intervention Phase
Anxiety Symptoms
Depressive Symptoms
Somatoform Symptoms
Behavioral: Cognitive Behavioral Group Therapy
Phase III

MedlinePlus related topics: Anxiety
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind (Outcomes Assessor), Factorial Assignment
Official Title: Efficacy of Child-Centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training

Further study details as provided by Philipps University Marburg Medical Center:

Primary Outcome Measures:
  • Child Behavior Checklist (german version) [ Time Frame: 3, 6, 18 months ]

Secondary Outcome Measures:
  • Inventar zur Erfassung der Lebensqualität bei Kindern und Jugendlichen (ILK)- Assessment of life quality, parent and child versions [ Time Frame: 3, 6, 18 months ]
  • Spence Children's Anxiety Scale (SCAS) [ Time Frame: 3, 6, 18 months ]
  • Depressionsinventar für Kinder- und Jugendliche (DIKJ), german depression inventory based on CDI [ Time Frame: 3, 6, 18 months ]
  • Giessener Beschwerdebogen für Kinder- und Jugendliche (GBB-KJ), report of somatic symptoms, parent and child versions [ Time Frame: 3, 6, 18 months ]
  • Culture Fair Intelligence Test (CFT 20-R) [ Time Frame: initially ]
  • Symptom-Checklist (SCL-90-R), german version [ Time Frame: 3, 6, 18 months ]

Estimated Enrollment: 120
Study Start Date: November 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions, 8 parent group sessions
B: Active Comparator Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions
C: No Intervention

Detailed Description:

Internalizing disorders represent a large group of psychological disorders among children who are referred to psychological treatment. Anxiety, Depression and somatoform disorders in children and adolescents increase the risk of mental disorders in adulthood. Some english programs have proved the efficacy of CBT-G prevention.This study will test the efficacy of CBT-G in German children. The role of parental involvement is currently subject to scientific discussions. The impact of an additional parent-group training will be investigated.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 8- 12 years and
  • anxiety symptoms and/or
  • depressive symptoms and/or
  • somatoform symptoms

Exclusion Criteria:

  • psychiatric disorder according to ICD-10/ DSM-IV-TR requiring individual psychotherapy
  • IQ < 85
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564239

Contacts
Contact: Jan Pauschardt, DP (MA) +49-6421-2863029 pauschar@med.uni-marburg.de
Contact: Sylvia D Eimecke, DP (MA) +49-6421-2863063 eimecke@med.uni-marburg.de

Locations
Germany, Hessen
Institut für Verhaltenstherapie und -medizin (IVV) Recruiting
Marburg, Hessen, Germany, D-35039
Contact: Ilse Karem, Secretary     +49-6421-2866472     karem@med.uni-marburg.de    
Principal Investigator: Jan Pauschardt, DP (MA)            
Sponsors and Collaborators
Philipps University Marburg Medical Center
Institute of Behavioral-Therapy and -Medicine at the Philipps University Marburg
Dept. of Child and Adolescent Psychiatry, Philipps University Marburg
Investigators
Principal Investigator: Jan Pauschardt, DP (MA) Philipps University Marburg Medical Center
Principal Investigator: Sylvia D Eimecke, DP (MA) Philipps University Marburg Medical Center
Study Director: Fritz Mattejat, PhD Philipps University Marburg Medical Center
  More Information

Study ID Numbers: IVV-001-2007, IVV-001-2007
Study First Received: November 26, 2007
Last Updated: May 20, 2008
ClinicalTrials.gov Identifier: NCT00564239  
Health Authority: Germany: Ethics Commission

Study placed in the following topic categories:
Depression
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 15, 2009