- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03690843
Development of Children With DCD Before the Age of Six
The Development of Children With Developmental Coordination Disorder (DCD) Before the Age of Six: a Follow-up Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A longitudinal study design enables us to assess children at three different ages (3y, 4y and 5y).
Assessment scores (AIMS or/and BSID) before the age of three will be retrieved retrospectively in the clinical group.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ghent, Belgium, 9000
- Ghent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria DCD group:
- 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
Inclusion Criteria controlgroup:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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DCD Group
Children diagnosed with DCD or at-risk DCD at two or three years of age
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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.
Other Names:
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Control Group
Typically developing children
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Developmental Coordination Disorder
Time Frame: This will be assessed at the age of 5 years.
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Presence or absence of a diagnosis of DCD as defined by the DSM-V diagnostic criteria.
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This will be assessed at the age of 5 years.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Movement Assessment Battery For children 2 - Dutch Version
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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The M-ABC-2-NL is a motor assessment battery for children age 3 to 16y including three subtests (manual dexterity, ball skills and balance).
The test battery was translated to Dutch and Dutch-Flemish norms are available.
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This will be assessed at the age of 3, 4 and 5 years.
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Beery-Buktenica Developmental test of Visual-Motor Integration 6
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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The Beery-VMI-6 measures the visual-motor integration skills and consists of three subtests (visual-motor integration, motor coordination and visual perception).
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This will be assessed at the age of 3, 4 and 5 years.
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Child Behaviour CheckList
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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The CBCL consists of 120 items (3-pointscale) questioning the child's behavior. Two versions are available (teacher and parent) in two age-ranges (1.5y - 6y and 6y - 18y). The absence or presence of features of emotional disorder, anxiety disorder, AD(H)D, OCD, CD and somatic disorder are examined. Both versions (parent + teacher) within the age-range 1.5 - 6y will be used. |
This will be assessed at the age of 3, 4 and 5 years.
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Functional Strength Measurement
Time Frame: This will be assessed at the age of 4 and 5 years.
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The FSM is a Dutch test assessing functional force in children 4 to 12y.
The test consists of 8 items in two domains (upper extremity and lower extremity).
Scores are presented either by limb (upper or lower limb) and/or by type of force (explosive power/endurance).
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This will be assessed at the age of 4 and 5 years.
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Young Children's Participation and Environment Measure
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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YC-PEM is a questionnaire for parents of children aged 0 to 6y.
The test consists of 73 items on three participation scales (frequency, involvement and desire to change) and one environment scale (amount of support by environment) measured in three domains (home, kindergarden/school and community).
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This will be assessed at the age of 3, 4 and 5 years.
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Little-DCD-Questionnaire
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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The L-DCD-Q-NL originates in Israel and was designed for children 3 to 4y.
It is a revision of the DCD-Q for older children.
The Flemish translation expanded the age category from 3 to 5y.
The L-DCD-Q is a parental questionnaire scoring 15 activities using a 5-point-Likert scale.
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This will be assessed at the age of 3, 4 and 5 years.
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Motor Skills Checklist (VMVK)
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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The VMVK is a Flemish teacher questionnaire consisting of 28 ADL-activities scored using a 4-point-scale.
Norms are available for children age 3 to 5y.
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This will be assessed at the age of 3, 4 and 5 years.
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Body Mass Index
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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Height and weight will be determined.
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This will be assessed at the age of 3, 4 and 5 years.
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Social Communication Questionnaire
Time Frame: This will be assessed at the age of 5 years.
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SCQ is a parental screening questionnaire for autism in children aged 4 years or older.
The questionnaire consists of 40 yes/no questions.
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This will be assessed at the age of 5 years.
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DCD-Daily Questionnaire
Time Frame: This will be assessed at the age of 5 years.
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The DCD-Daily-Q is a Dutch parental questionnaire (5 - 8y) consisting of 23 ADL-activities (3-point scale) in three domains: how often the child participates (participation scale), how well the child performs (quality scale) and the time the child needs to learn new skills (learning scale).
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This will be assessed at the age of 5 years.
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Teacher report form
Time Frame: This will be assessed at the age of 3, 4 and 5 years.
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The TRFconsists of 120 items (3-pointscale) questioning the child's behavior.
Two versions are available (teacher and parent) in two age-ranges (1.5y - 6y and 6y - 18y).
The absence or presence of features of emotional disorder, anxiety disorder, AD(H)D, OCD, CD and somatic disorder are examined.
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This will be assessed at the age of 3, 4 and 5 years.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy Roubaix, University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B670201837290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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