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NCT06183411 Clinical Trial

Theory of Mind in Children With DCD

Developmental Coordination Disorder Clinical Trial

— TOM_DCD  

Official title:
Theory of Mind in Children With DCD

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06183411
Other study ID # ONZ-2023-0329
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 17, 2023
Est. completion date October 30, 2024

Study information
Verified date December 2023
Source University Ghent
Contact Lynn Bar-On, Prof. Dr.
Phone +3293326920
Email lynn.baron@ugent.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. In addition, children should be six until twelve years old with a DCD diagnosis confirmed by a multidisciplinary team (including a doctor). During the test moment, ToM will be tested by ToM test-R and the motor skills by MABC-2. Beside, the ToM test-R will be filmed, but the child's face not shown. The parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, CVO, SRS-2, SDQ and ToMBC), this can be completed in advance at home or at the test moment (researchers provide a laptop).

Recruitment information / eligibility
Status Recruiting
Enrollment 90
Est. completion date October 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria: - Age of child: from six to 12 years old - Confirmed diagnosis of DCD by a multidisciplinary team (including a physician) - Child lives in Flanders or the Netherlands - Child has Dutch as the mother tongue Exclusion Criteria: - Diagnosis of autism spectrum disorder (ASD) - Blood related siblings of the child - Parent/legal guardian does not have an adequate level of Dutch - (IQ lower than 70) OR (no IQ information and child attends special education type 1 (mild intellectual disability) or type 2 (moderate to severe mental disability))

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Assessment
Observations using two valid, observational instruments (MABC-2 and ToM test-R) that each child completes once at random. A demographic and developmental questionnaire is completed once by the parent/guardian at recruitment. Standardized questionnaires (Coordination Questionnaire For Parents (CVO), Social Responsiveness Scale second edition (SRS-2), Strengths and Difficulties Questionnaire (SDQ) and Theory of Mind Behavior Checklist (ToMBC)) are also questioned once to parent/guardian for data collection.

Locations
Country Name City State
Belgium Universiteit Gent - Vakgroep revalidatiewetenschappen Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Theory of Mind Measured with ToM test-R andTheory of Mind Behavior Checklist (ToMBC) 2 hours
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