NCT06183411

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 27, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

8 months

First QC Date

December 13, 2023

Last Update Submit

December 13, 2023

Conditions

Keywords

ChildDevelopmentTheory of mind

Outcome Measures

Primary Outcomes (1)

  • Theory of Mind

    Measured with ToM test-R andTheory of Mind Behavior Checklist (ToMBC)

    2 hours

Study Arms (1)

Children with DCD

OTHER
Behavioral: Assessment

Interventions

AssessmentBEHAVIORAL

* 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.

Children with DCD

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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))

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universiteit Gent - Vakgroep revalidatiewetenschappen

Ghent, Belgium

RECRUITING

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior ControlTherapeuticsImmobilizationInvestigative Techniques

Central Study Contacts

Lynn Bar-On, Prof. Dr.

CONTACT

Lynn Bar-On, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Lynn Bar-On

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 27, 2023

Study Start

November 17, 2023

Primary Completion

June 30, 2024

Study Completion

October 30, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations