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

NCT02628015 | Unknown

• 1 other identifier: ToM-2016-2018
• Study Type: observational
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth

Keywords

Theory of Mind; Very Low Birthweight Infants

Outcome Measures

Primary Outcomes (11)

• theory of mind 1

  Theory of Mind Scale (Group 1 and 2)

  up to 7 months

• executive function 1

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

  up to 7 months

• executive function 2

  Tower of London (all groups)

  up to 7 months

• 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

• 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

• theory of mind 2

  Mental State Stories (Group 2, 3 and 4)

  up to 7 months

• theory of mind 3

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

  up to 7 months

• theory of mind 4

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

  up to 7 months

• theory of mind 5

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

  up to 7 months

• Language 2

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

  up to 7 months

• 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

Study Arms (8)

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

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

preterms were born in the University Hospital of Cologne

You may qualify if:

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

You may not qualify if:

• no informed consent

Sponsors & Collaborators

• University of Bonn: lead
• University Hospital of Cologne: collaborator

Study Sites (1)

University of Bonn

Bonn, 53111, Germany

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Stephanie Braun, M.Sc.

CONTACT

0049 228 73; stbraun@uni-bonn.de

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master of Science, Psychologist

Study Record Dates

• First Submitted: November 14, 2015
• First Posted: December 11, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 14, 2016

Record last verified: 2016-03

Locations

DE (1)