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Trial record 1 of 206 for:    Theory of MInd
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Theory of Mind in Preschool Children, School Children, Youths and Adults Born Preterm or Full-term

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ClinicalTrials.gov Identifier: NCT02628015
Recruitment Status : Recruiting
First Posted : December 11, 2015
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Premature Birth

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 Design

Study Type : Observational
Estimated Enrollment : 480 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Theory of Mind Bei Ehemals früh- Und Reifgeborenen Vorschulkindern, Schulkindern, Jugendlichen Und Erwachsenen
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toddler Health
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. theory of mind 1 [ Time Frame: up to 7 months ]
    Theory of Mind Scale (Group 1 and 2)

  2. executive function 1 [ Time Frame: up to 7 months ]
    Teddy-bear-Set-Shifting Task (all groups)

  3. executive function 2 [ Time Frame: up to 7 months ]
    Tower of London (all groups)

  4. 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


  5. 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

  6. theory of mind 2 [ Time Frame: up to 7 months ]
    Mental State Stories (Group 2, 3 and 4)

  7. theory of mind 3 [ Time Frame: up to 7 months ]
    Faux Pas Stories (Group 2, 3, and 4)

  8. theory of mind 4 [ Time Frame: up to 7 months ]
    Reading the mind in the Eyes Test Revised (Group 4)

  9. theory of mind 5 [ Time Frame: up to 7 months ]
    Cambridge Mindreading Face-Voice Battery (only visual Items) (Group 4)

  10. Language 2 [ Time Frame: up to 7 months ]
    CFT 20 R - Vocabulary Task (group 2,3,4)

  11. 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


Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: December 11, 2015    Key Record Dates
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