Trial document





This trial has been registered retrospectively.
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  DRKS00006233

Trial Description

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Title

Theory of mind in CII children between 3 and 5;11 Years

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Research shows that children with Cochlear implants are late in developping theory of mind. Theory of mind is the ability to attribute mental states like pretending, beliefs, intents, desires to others. We want to compare deaf children with CI and normal Hearing children in kindergarden. The results are important for early detection and Intervention.

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Brief Summary in Scientific Language

Comparison of TOM in deaf children with CI to normal Hearing children in kindergarden.

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Organizational Data

  •   DRKS00006233
  •   2014/06/11
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  •   yes
  •   Approved
  •   14-25, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1157-8542 
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Health Condition or Problem studied

  •   H90.3 -  Sensorineural hearing loss, bilateral
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Interventions/Observational Groups

  •   Children with cochlear implant
    examinations at primary outcome
  •   Children in Kindergarden
    examinations at primary outcome
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Diagnostic
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The following Test where done with the children:
„Theory of Mind“-Skala vor children between 3-11 (Peterson, Wellman and Slaughter (2012)

Teddy-bear Set-shifting Task (Hughes 1998)

Subtest Understanding of SETK 3-5 (Grimm, Aktas & Frevert, 2010)

Subtest Thinking of SON 2 ½-7 (Tellegen, Laros & Petermann, 2007).

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Secondary Outcome

Comparison Results of CI and Kindergarden group

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • other 
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Recruitment

  •   Actual
  •   2014/04/01
  •   30
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Years
  •   6   Years
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Additional Inclusion Criteria

deaf, Cochlear implant

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Exclusion Criteria

further handycap

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Addresses

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    • Uniklinik Köln HNO Phoniatrie und Pädaudiologie
    • 50924  Köln
    • Germany
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    • Institut für Psychologie, Abteilung Entwicklungspsychologie und pädagogische Psychologie der Rheinischen Friedrich-Wilhelms-Universität Bonn
    • Mr.  PD DR.  Michael  Kavsek 
    • Kaiser-Karl-Ring 9
    • 53111  Bonn
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    • Uniklinik KölnPhoniatrie und Pädaudiologie
    • Ms.  Dr. med.  Ruth  Lang-Roth 
    • Kerpenerstrasse 62
    • 50924  Köln
    • Germany
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    • Uniklinik Köln Phoniatrie und Pädaudiologie
    • Ms.  Dr. med.  Ruth  Lang-Roth 
    • Kerpenerstrasse 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Uniklinik Köln HNO
    • 50924  Köln
    • 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.