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Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02628015
Recruitment Status : Unknown
Verified March 2016 by Stephanie Braun, University of Bonn.
Recruitment status was:  Recruiting
First Posted : December 11, 2015
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
University Hospital of Cologne
Information provided by (Responsible Party):
Stephanie Braun, University of Bonn

Tracking Information
First Submitted Date November 14, 2015
First Posted Date December 11, 2015
Last Update Posted Date March 14, 2016
Study Start Date March 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 8, 2015)
  • theory of mind 1 [ Time Frame: up to 7 months ]
    Theory of Mind Scale (Group 1 and 2)
  • executive function 1 [ Time Frame: up to 7 months ]
    Teddy-bear-Set-Shifting Task (all groups)
  • executive function 2 [ Time Frame: up to 7 months ]
    Tower of London (all groups)
  • Language 1 [ Time Frame: up to 7 months ]
    SETK 3-5 - Language Understanding Task (Group 1) there will be only one score for each participant, but there is a different task for the first group, than for the others
  • cognitive abilities 1 [ Time Frame: up to 7 months ]
    SON 2 1/2 - 7 - Two subtests: Analogies and Categories (group 1) there will be two test-scores for each participant, but they can be aggregated to one score for cognitive abilities
  • theory of mind 2 [ Time Frame: up to 7 months ]
    Mental State Stories (Group 2, 3 and 4)
  • theory of mind 3 [ Time Frame: up to 7 months ]
    Faux Pas Stories (Group 2, 3, and 4)
  • theory of mind 4 [ Time Frame: up to 7 months ]
    Reading the mind in the Eyes Test Revised (Group 4)
  • theory of mind 5 [ Time Frame: up to 7 months ]
    Cambridge Mindreading Face-Voice Battery (only visual Items) (Group 4)
  • Language 2 [ Time Frame: up to 7 months ]
    CFT 20 R - Vocabulary Task (group 2,3,4)
  • cognitive abilities 2 [ Time Frame: up to 7 months ]
    SON 6-40 - Two subtests: Analogies and Categories (group 2,3,4) there will be two test-scores for each participant, but they can be aggregated to one score for cognitive abilities
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term
Official Title Theory of Mind Bei Ehemals früh- Und Reifgeborenen Vorschulkindern, Schulkindern, Jugendlichen Und Erwachsenen
Brief Summary This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.
Detailed Description

Is there any difference in the development of theory of mind between preterms and full-terms? Is there a risk group of preterms to develop a deficit in theroy of mind?

Four groups are tested: prescoolers (again two years later), youths and young adults.

All participants were tested for theory of mind, executive functions, language and cognitive abilites.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population preterms were born in the University Hospital of Cologne
Condition Premature Birth
Intervention Not Provided
Study Groups/Cohorts
  • preschool children preterm
    born 2010 or 2011 Birthweight <1500g
  • preschool children full-term
    born 2010 or 2011 born after 38 weeks
  • school children preterm
    same children from the preschool group will be tested 2 years later again
  • school children full-term
    same children from the preschool group will be tested 2 years later again
  • youths preterm
    born 2001 or 2002 Birthweight <1500g
  • youths full-term
    born 2001 or 2002 born after 38 weeks
  • adults preterm
    Birthweight <1500g
  • adults full-term
    born after 38 weeks
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: December 8, 2015)
480
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • informed consent
  • preterm: birthweight <1500g
  • full-term: born after 38 weeks

Exclusion Criteria:

  • no informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 4 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02628015
Other Study ID Numbers ToM-2016-2018
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Stephanie Braun, University of Bonn
Original Responsible Party Same as current
Current Study Sponsor University of Bonn
Original Study Sponsor Same as current
Collaborators University Hospital of Cologne
Investigators Not Provided
PRS Account University of Bonn
Verification Date March 2016