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Trial record 1 of 198 for:    Theory of MInd
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Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term

This study is currently recruiting participants.
Verified March 2016 by Stephanie Braun, University of Bonn
Sponsor:
ClinicalTrials.gov Identifier:
NCT02628015
First Posted: December 11, 2015
Last Update Posted: March 14, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
University Hospital of Cologne
Information provided by (Responsible Party):
Stephanie Braun, University of Bonn
  Purpose
This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.

Condition
Premature Birth

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Theory of Mind Bei Ehemals früh- Und Reifgeborenen Vorschulkindern, Schulkindern, Jugendlichen Und Erwachsenen

Resource links provided by NLM:


Further study details as provided by Stephanie Braun, University of Bonn:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 480
Study Start Date: March 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
preterms were born in the University Hospital of Cologne
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent
  Contacts and Locations
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): NCT02628015


Contacts
Contact: Stephanie Braun, M.Sc. 0049 228 73 ext 4472 stbraun@uni-bonn.de

Locations
Germany
University of Bonn Recruiting
Bonn, Germany, 53111
Sponsors and Collaborators
University of Bonn
University Hospital of Cologne
  More Information

Responsible Party: Stephanie Braun, Master of Science, Psychologist, University of Bonn
ClinicalTrials.gov Identifier: NCT02628015     History of Changes
Other Study ID Numbers: ToM-2016-2018
First Submitted: November 14, 2015
First Posted: December 11, 2015
Last Update Posted: March 14, 2016
Last Verified: March 2016

Keywords provided by Stephanie Braun, University of Bonn:
Theory of Mind
Very Low Birthweight Infants

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications


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