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Psychological Prevention of Internalizing Disorders

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ClinicalTrials.gov Identifier: NCT00564239
Recruitment Status : Completed
First Posted : November 27, 2007
Last Update Posted : April 30, 2018
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 (Responsible Party):
Jan Pauschardt, Philipps University Marburg Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Anxiety Symptoms Depressive Symptoms Somatoform Symptoms Behavioral: Cognitive Behavioral Group Therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Efficacy of Child-centered Cognitive-Behavioral Prevention of Internalizing Disorders and the Impact of Simultaneous Parent Training
Study Start Date : November 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jan Pauschardt, Dr. rer. nat., Philipps University Marburg Medical Center
ClinicalTrials.gov Identifier: NCT00564239     History of Changes
Other Study ID Numbers: IVV-001-2007
IVV-001-2007
First Posted: November 27, 2007    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
Depression
Behavioral Symptoms