Trial document




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  DRKS00012444

Trial Description

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Title

Impact factors and conditions of somatoform symptoms in childhood within familial and school contexts

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Trial Acronym

SOM-SiK

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Often parents find themselves in the situation that their children complain about recurring physical symptoms, like headaches or stomach aches. These symptoms can often not be explained by a pediatric diagnosis. In this case we talk about "somatoform symptoms". These symptoms are often so severe that the affected children cannot go to school. If the afflictions are longer lasting, problems like truancy, limitation of childs activities and withdrawal from contact can become further negative factors for the children themselves, but also for their families. A vicious cycle consisting of pain, mental overload and helplessness can develop.
This research project (Dissertation project of Dipl.-Psych. Christina Vesterling under the guidance of Prof. Dr. Ute Koglin) aims to investigate the impact factor of somatoform symptoms, as well as the circumstances that maintain the symptoms or worsen them. The result of this research shoud help to better understand the correlational structure of somatoform symptoms in children. The objective of this research is the developement of possible prevention programs, i.e., treatment methods.

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Brief Summary in Scientific Language

The objective of the research project is to investigate the circumstances under which somatoform symptoms in childhood occur and are maintained. Especially reflections of possible correlations between attachment theory, emotion regulation and theory of learning, constitute the focus of this study.
This research project aims to identify possible influences and risk factors.
Results of this research could serve as a basis for the developement of prevention programs, which could facilitate a good networking between pediatricians, child psychiatrists and child psychotherapists, affected children and their parents.
The present study is planned for the durtion of 3,5 years.
During this time, a longitudinal study over two time periods should supply data from clinical (psychiatric and pediatric) and non-clinical (school) samples.
This data ascertainment will take place after parents, children and teachers have submitted informed consents.
The survey will contain questionnaires about the subjects mentioned above.
The evaluation should allow a cross-selectional, as well as a longitudinal view of the topic at hand.

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Organizational Data

  •   DRKS00012444
  •   2018/04/10
  •   [---]*
  •   yes
  •   Approved
  •   2017-011, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F45 -  Somatoform disorders
  •   somatoform symptoms in childhood
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Interventions/Observational Groups

  •   Children, parents and teachers complete questionnaires about the subjects behavioral analysis, personality and healthiness at two time periods
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

1. Time period: from February-July 2018 and
March-July 2019
Survey (children):
- Screening für somatoforme Störungen des Kindes-und Jugendalters SOMS KJ (Winter et al., 2008; 2014)
- Adaption of the Experiences in Close Relationship Scale-Revised ECR-RC (Brenning et al., 2011)
- Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen FEEL-KJ (Grob & Smolenski, 2009)

Survey (parents):
- Child Behavior Checklist CBCL/6-18 (Achenbach & Rescorla, Revision 2001, deutschsprachige Revision Bearbeitung: Arbeitsgruppe Deutsche Child Behavior Checklist. (2014)
- Parental Overprotection Measure OP
(Edwards et al. 2008, 2010)

Survey (teacher):
- Student -Teacher Relationship Scale (STRS)
(Pianta, 1996)

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Secondary Outcome

2. Time period: planned from February-July
2019 and March- July 2020

Survey (children):
- Screening für somatoforme Störungen des Kindes-und Jugendalters SOMS KJ (Winter et al., 2008; 2014)
- Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen FEEL-KJ (Grob & Smolenski, 2009)

Survey (parents):
- Child Behavior Checklist CBCL/6-18 (Achenbach & Rescorla, Revision 2001, deutschsprachige Revision Bearbeitung: Arbeitsgruppe Deutsche Child Behavior Checklist. (2014)
- Parental Overprotection Measure OP (Edwards et al. 2008, 2010)

Survey (teacher):
- Student -Teacher Relationship Scale (STRS)
(Pianta, 1996)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Doctor's Practice 
  • other 
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Recruitment

  •   Actual
  •   2018/04/10
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

- in 4th grade at the beginning of the study.
- adequte knowledge of german language to complete the questionnaire.
- written consent from the parents to partake in the study.
- written consent that the parents agree that they will be informed if the questionnaire results reveal any suggestion of mental abnormality in their children.

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Exclusion Criteria

Exclusion Criteria are not defined

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Addresses

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    • C.v.O. Universität OldenburgFakultät I Institut für Sonder- und RehabilitationspädagogikFachgruppe Sonder- und Rehabilitationspädagogische Psychologie
    • Ms.  Prof. Dr.  Ute  Koglin 
    • Postfach 2503
    • 26111  Oldenburg
    • Germany
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    • Kinderklinik des Josef Hospital Delmenhorst
    • Mr. 
    • Wildeshausener Str. 92
    • 27753  Delmenhorst
    • Germany
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    •   04221 99-4403
    •   [---]*
    •   [---]*
    •   [---]*
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    • C.v.O. Universität OldenburgFakultät I Institut für Sonder- und RehabilitationspädagogikFachgruppe Sonder- und Rehabilitationspädagogische Psychologie
    • Ms.  Prof. Dr.  Ute  Koglin 
    • Postfach 2503
    • 26111  Oldenburg
    • Germany
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    • C.v.O. Universität Oldenburg Fakultät I Institut für Sonder- und Rehabilitationspädagogik Fachgruppe Sonder- und Rehabilitationspädagogische Psychologie
    • Ms.  Christina  Vesterling 
    • Ammerländer Heerstrasse 114-118
    • 26129  Oldenburg
    • Germany
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Sources of Monetary or Material Support

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    • C.v.O. Universität OldenburgFakultät I Institut für Sonder- und RehabilitationspädagogikFachgruppe Sonder- und Rehabilitationspädagogische Psychologie
    • Ms.  Prof. Dr.  Ute  Koglin 
    • Postfach 2503
    • 26111  Oldenburg
    • 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.