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

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02628015
• Other study ID #: ToM-2016-2018
• Status: Recruiting
• Phase: N/A
• First received: November 14, 2015
• Last updated: March 11, 2016
• Start date: March 2016
• Est. completion date: December 2018

Study information

• Verified date: March 2016
• Source: University of Bonn
• Contact: Stephanie Braun, M.Sc.
• Phone: 0049 228 73
• Email: stbraun[@]uni-bonn.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 480
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 4 Years and older

Eligibility

Inclusion Criteria:

• informed consent

• preterm: birthweight <1500g

• full-term: born after 38 weeks

Exclusion Criteria:

• no informed consent

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Premature Birth

Locations

Country	Name	City	State
Germany	University of Bonn	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
University of Bonn	University Hospital of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	theory of mind 1	Theory of Mind Scale (Group 1 and 2)	up to 7 months	No
Primary	executive function 1	Teddy-bear-Set-Shifting Task (all groups)	up to 7 months	No
Primary	executive function 2	Tower of London (all groups)	up to 7 months	No
Primary	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	up to 7 months	No
Primary	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	up to 7 months	No
Primary	theory of mind 2	Mental State Stories (Group 2, 3 and 4)	up to 7 months	No
Primary	theory of mind 3	Faux Pas Stories (Group 2, 3, and 4)	up to 7 months	No
Primary	theory of mind 4	Reading the mind in the Eyes Test Revised (Group 4)	up to 7 months	No
Primary	theory of mind 5	Cambridge Mindreading Face-Voice Battery (only visual Items) (Group 4)	up to 7 months	No
Primary	Language 2	CFT 20 R - Vocabulary Task (group 2,3,4)	up to 7 months	No
Primary	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	up to 7 months	No