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

March 11, 2016 updated by: Stephanie Braun, University of Bonn

Theory of Mind Bei Ehemals früh- Und Reifgeborenen Vorschulkindern, Schulkindern, Jugendlichen Und Erwachsenen

This study tests preschoolers, school children, youths and young adults, who were born preterm or full-term, in their theory of mind abilities.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

480

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53111
        • Recruiting
        • University of Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

preterms were born in the University Hospital of Cologne

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
theory of mind 1
Time Frame: up to 7 months
Theory of Mind Scale (Group 1 and 2)
up to 7 months
executive function 1
Time Frame: up to 7 months
Teddy-bear-Set-Shifting Task (all groups)
up to 7 months
executive function 2
Time Frame: up to 7 months
Tower of London (all groups)
up to 7 months
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
up to 7 months
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
up to 7 months
theory of mind 2
Time Frame: up to 7 months
Mental State Stories (Group 2, 3 and 4)
up to 7 months
theory of mind 3
Time Frame: up to 7 months
Faux Pas Stories (Group 2, 3, and 4)
up to 7 months
theory of mind 4
Time Frame: up to 7 months
Reading the mind in the Eyes Test Revised (Group 4)
up to 7 months
theory of mind 5
Time Frame: up to 7 months
Cambridge Mindreading Face-Voice Battery (only visual Items) (Group 4)
up to 7 months
Language 2
Time Frame: up to 7 months
CFT 20 R - Vocabulary Task (group 2,3,4)
up to 7 months
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
up to 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bonn

Collaborators

University Hospital of Cologne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

November 14, 2015

First Submitted That Met QC Criteria

December 8, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ToM-2016-2018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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