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Psychological Prevention of Internalizing Disorders

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2010 by Philipps University Marburg Medical Center.
Recruitment status was:  Recruiting
Sponsor:
Collaborators:
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
First received: November 26, 2007
Last updated: August 27, 2010
Last verified: August 2010
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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 2012
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions, 8 parent group sessions
Active Comparator: B Behavioral: Cognitive Behavioral Group Therapy
12 children group sessions
No Intervention: C

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   (Child)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00564239

Locations
Germany
Institut für Verhaltenstherapie und -medizin (IVV)
Marburg, Hessen, Germany, D-35039
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, Dr. Philipps University Marburg Medical Center
Principal Investigator: Sylvia D Eimecke, Dr. Philipps University Marburg Medical Center
Study Director: Fritz Mattejat, PhD Philipps University Marburg Medical Center
  More Information

Responsible Party: Mattejat, F., PhD, Institute of Behavioral-Therapy and -Medicine at the Philipps University MarburgDept. of Child and Adolescent Psychiatry, Philipps University Marburg
ClinicalTrials.gov Identifier: NCT00564239     History of Changes
Other Study ID Numbers: IVV-001-2007 
Study First Received: November 26, 2007
Last Updated: August 27, 2010

Additional relevant MeSH terms:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on February 20, 2017