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Status unknownNCT02628015Updated Mar 14, 2016

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

An observational study in Premature Birth, sponsored by University of Bonn. Status unknown at 1 site in Germany. Open to participants aged 4 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-03-14.

Sponsored by University of Bonn · Observational

The sponsor has not verified this record recently (last verified Mar 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
480
Ages
4 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Premature Birth

Browse trials for

Keywords

  • Theory of Mind
  • Very Low Birthweight Infants
03

In context

Premature Birth

2,615 studies on the registry are indexed under Premature Birth; 507 are open to participants now.

This study's planned enrollment of 480 is above the median of 115 across 798 observational studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

University of Bonn is the lead sponsor of 39 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
4 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

preterms were born in the University Hospital of Cologne

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • no informed consent
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
480 participants (estimated)
Patient registry
No

Groups and 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

06

What researchers measure

Primary outcomes

  1. theory of mind 1

    Theory of Mind Scale (Group 1 and 2)

    Time frame: up to 7 months

  2. executive function 1

    Teddy-bear-Set-Shifting Task (all groups)

    Time frame: up to 7 months

  3. executive function 2

    Tower of London (all groups)

    Time frame: up to 7 months

  4. Language 1

    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

    Time frame: up to 7 months

  5. cognitive abilities 1

    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

    Time frame: up to 7 months

  6. theory of mind 2

    Mental State Stories (Group 2, 3 and 4)

    Time frame: up to 7 months

  7. theory of mind 3

    Faux Pas Stories (Group 2, 3, and 4)

    Time frame: up to 7 months

  8. theory of mind 4

    Reading the mind in the Eyes Test Revised (Group 4)

    Time frame: up to 7 months

  9. theory of mind 5

    Cambridge Mindreading Face-Voice Battery (only visual Items) (Group 4)

    Time frame: up to 7 months

  10. Language 2

    CFT 20 R - Vocabulary Task (group 2,3,4)

    Time frame: up to 7 months

  11. cognitive abilities 2

    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

    Time frame: up to 7 months

07

Study locations

1 of 1 sites recruiting
  • University of Bonn
    Bonn, 53111, Germany
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2016, a primary completion of Dec 2018 and a completion of Dec 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 14, 2015
First posted
Dec 11, 2015
Start
Mar 2016
Primary completionEst.
Dec 2018
CompletionEst.
Dec 2018
Last update
Mar 14, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02628015
Lead sponsor
University of Bonn
Collaborators
University Hospital of Cologne
Responsible party
Stephanie Braun (Master of Science, Psychologist, University of Bonn) — Principal investigator
First posted
Dec 11, 2015
Start date
Mar 2016
Primary completion
Dec 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Mar 14, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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