Trial document





This trial has been registered retrospectively.
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  DRKS00000235

Trial Description

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Title

Efficacy of Child-Centered Cognitive-Behavioral Prevention of Internalizing Disorders and Impact of a Simultaneous Parent Training

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Trial Acronym

Psychologische Prävention Internalisierender Störungen

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URL of the Trial

http://www.uni-marburg.de/ivv/aktuelles/news/angstpraevention

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Brief Summary in Lay Language

Anxiety, Depression and somatoform Disorders are very common in child psychopathology. The efficacy of a psychological group program for children aged 8-12 to prevent these disorders and an additional parent training are evaluated.

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Brief Summary in Scientific Language

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.

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Organizational Data

  •   DRKS00000235
  •   2010/01/11
  •   2007/11/26
  •   yes
  •   Approved
  •   Studie 04/07, Ethik-Kommission des Fachbereichs Medizin der Philipps-Universität Marburg
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Secondary IDs

  •   U1111-1111-1194 
  •   NCT00564239  (Clinicaltrials.gov)
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Health Condition or Problem studied

  •   F40.1 -  Social phobias
  •   F41.1 -  Generalized anxiety disorder
  •   F41.2 -  Mixed anxiety and depressive disorder
  •   F32.0 -  Mild depressive episode
  •   F32.1 -  Moderate depressive episode
  •   F34.1 -  Dysthymia
  •   F93.0 -  Separation anxiety disorder of childhood
  •   F93.1 -  Phobic anxiety disorder of childhood
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Interventions/Observational Groups

  •   Cognitive-behavioral group intervention with parental psychoeducation (active control)
  •   Cognitive-behavioral group intervention plus parent training (intervention group)
  •   Waitlist control
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Prevention
  •   Parallel
  •   N/A
  •   [---]*
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Primary Outcome

youth psychopathology via parent report using the Child Behavior Checklist (CBCL); Time Frame: 0, 3, 6 and 18 months

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Secondary Outcome

Assessment of life quality (ILK), parent and child versions; Time Frame: 0, 3, 6 and 18 months || Youth Anxiety Symptoms by self- and parent report using the Spence Children's Anxiety Scale (SCAS) and the FBB-ANG (parent report on anxiety symptoms), Time Frame: 0, 3, 6 and 18 months || Youth Depression Symptoms by self report using the DIKJ (german depression inventory based on CDI); Time Frame: 0, 3, 6 and 18 months || Youth somatoform symptoms by parent and self report using the GBB-KJ (report of somatic symptoms), Time Frame: 0, 3, 6 and 18 months || Parental Psychopathology via self-report using the Symptom-Checklist (SCL-90-R), german version, Time frame: 0, 3, 6 and 18 months || Youth Intelligence using Culture Fair Intelligence Test (CFT 20-R); Time frame: once at start of intervention

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2007/07/15
  •   120
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   12   Years
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Additional Inclusion Criteria

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

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Exclusion Criteria

-psychiatric disorder according to ICD-10 requiring individual psychotherapy
-IQ < 85

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Institut für Verhaltenstherapie und Verhaltensmedizin an der Philipps-Universität Marburg
    • Mr.  Prof. Dr.  Fritz  Mattejat 
    • Hans-Sachs-Str.4-6
    • 35039  Marburg
    • Germany
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    • Institut für Verhaltenstherapie und Verhaltensmedizin an der Philipps-Universität Marburg
    • Mr.  Dr.  Jan  Pauschardt 
    • Hans-Sachs-Str.4-6
    • 35037  Marburg
    • Germany
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    • Institut für Verhaltenstherapie und Verhaltensmedizin an der Philipps Universität Marburg
    • Mr.  Dr.  Jan  Pauschardt 
    • Hans-Sachs-Str.4-6
    • 35037  Marburg
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Verhaltenstherapie und -medizin an der Philipps-Universität Marburg
    • Mr.  Prof. Dr.  Fritz  Mattejat 
    • Hans-Sachs-Str.4-6
    • 35039  Marburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.