NCT03690843

Brief Summary

The aim of this study is to map the early development of children with DCD and compare it to typically developing (TD) children. At first we will investigate to what extent motor delay, reduced force, higher BMI, behavioral, ADL and participation problems occur in toddlerhood in DCD children and how this relates to TD children. We will also look into the evolution of these parameters in time (stability of development). Secondly we will explore if the diagnosis of DCD can be predicted using a standardized test before the age of five.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

October 8, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2023

Completed
Last Updated

April 10, 2023

Status Verified

December 1, 2022

Enrollment Period

4.2 years

First QC Date

September 27, 2018

Last Update Submit

April 7, 2023

Conditions

Keywords

motor developmenttoddlerprediction

Outcome Measures

Primary Outcomes (1)

  • Developmental Coordination Disorder

    Presence or absence of a diagnosis of DCD as defined by the DSM-V diagnostic criteria.

    This will be assessed at the age of 5 years.

Secondary Outcomes (11)

  • Movement Assessment Battery For children 2 - Dutch Version

    This will be assessed at the age of 3, 4 and 5 years.

  • Beery-Buktenica Developmental test of Visual-Motor Integration 6

    This will be assessed at the age of 3, 4 and 5 years.

  • Child Behaviour CheckList

    This will be assessed at the age of 3, 4 and 5 years.

  • Functional Strength Measurement

    This will be assessed at the age of 4 and 5 years.

  • Young Children's Participation and Environment Measure

    This will be assessed at the age of 3, 4 and 5 years.

  • +6 more secondary outcomes

Study Arms (2)

DCD Group

Children diagnosed with DCD or at-risk DCD at two or three years of age

Other: Test Battery

Control Group

Typically developing children

Other: Test Battery

Interventions

All toddlers (DCD children + TD children) included in the study will be tested at three points in time, that is at the age of 3y, 4y and 5y with an extensive test battery. Questionnaires will be filled in by parents and teachers. Children will be tested using different instruments.

Also known as: Movement Assessment Battery for Children 2, Beery-VMI-6, Functional Strength Measurement, Child Behaviour Checklist, Little-DCD-Questionnaire, Teacher Report Form, DCD-Daily-Questionnaire, Vragenlijst motorische vaardigheden kleuters, Body mass Index, YC-PEM, Social Communication Questionnaire
Control GroupDCD Group

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children attending the Center of Developmental Disabilities Ghent.

You may qualify if:

  • The multidisciplinary team of the Center of Developmental Disabilities reports that the child has DCD or is at-risk for developing DCD and this at the age of 2 and/or 3 years.
  • At least one parent speaks Dutch to the child
  • The child is three years of age at the moment of the first testing
  • Little-DCD-Q score ≥ 55 at 3y
  • M-ABC-2 percentilescore ≥25 at 3y
  • No medical diagnoses possibly influencing the motor development (DCD, ADHD, ASS, CP,…)
  • No history of developmental motor stimulation (therapy) and/or support
  • Gestational age ≥37w
  • Birthweight ≥2500g
  • At least one parent speaks Dutch to the child

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Motor Skills Disorders

Interventions

Body Mass Index

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Body Weights and MeasuresBody ConstitutionPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosisAnthropometryInvestigative TechniquesPhysiological PhenomenaBiometryEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Amy Roubaix

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 1, 2018

Study Start

October 8, 2018

Primary Completion

January 6, 2023

Study Completion

January 6, 2023

Last Updated

April 10, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations