Developmental Coordination DisorderNCT03690843
Development of Children With DCD Before the Age of Six
An observational study of Developmental Coordination Disorder, run by University Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Test Battery
- How many people
- 70 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Oct 2018to 6 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children attending the Center of Developmental Disabilities Ghent.
Who may be able to join
- 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,…)
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- No history of developmental motor stimulation (therapy) and/or support
- Gestational age ≥37w
- Birthweight ≥2500g
- At least one parent speaks Dutch to the child
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Developmental Coordination Disorder
- Being tested
- Test Battery
- Keywords
- motor development, toddler, prediction
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test BatteryOther
Also called Movement Assessment Battery for Children 2, Beery-VMI-6, Functional Strength Measurement, Child Behaviour Checklist
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.
| Study group | Role | What they receive |
|---|---|---|
| DCD Group | Children diagnosed with DCD or at-risk DCD at two or three years of age Receives: Other: Test Battery | |
| Control Group | Typically developing children Receives: Other: Test Battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Developmental Coordination Disorder
Presence or absence of a diagnosis of DCD as defined by the DSM-V diagnostic criteria.
Measured: This will be assessed at the age of 5 years.
Secondary outcomes (11)
Movement Assessment Battery For children 2 - Dutch Version
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.
Measured: This will be assessed at the age of 3, 4 and 5 years.
Beery-Buktenica Developmental test of Visual-Motor Integration 6
The Beery-VMI-6 measures the visual-motor integration skills and consists of three subtests (visual-motor integration, motor coordination and visual perception).
Measured: This will be assessed at the age of 3, 4 and 5 years.
Child Behaviour CheckList
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.
Measured: This will be assessed at the age of 3, 4 and 5 years.
Functional Strength Measurement
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).
Measured: This will be assessed at the age of 4 and 5 years.
Young Children's Participation and Environment Measure
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).
Measured: This will be assessed at the age of 3, 4 and 5 years.
Little-DCD-Questionnaire
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.
Measured: This will be assessed at the age of 3, 4 and 5 years.
Motor Skills Checklist (VMVK)
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.
Measured: This will be assessed at the age of 3, 4 and 5 years.
DCD-Daily Questionnaire
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).
Measured: This will be assessed at the age of 5 years.
Body Mass Index
Height and weight will be determined.
Measured: This will be assessed at the age of 3, 4 and 5 years.
Social Communication Questionnaire
SCQ is a parental screening questionnaire for autism in children aged 4 years or older. The questionnaire consists of 40 yes/no questions.
Measured: This will be assessed at the age of 5 years.
Teacher report form
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.
Measured: This will be assessed at the age of 3, 4 and 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start8 Oct 2018
- Primary completion6 Jan 2023
- Study completion6 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Roubaix, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690843
- Sponsor's protocol ID
- B670201837290
- Status last verified
- Dec 2022
- First submitted
- 27 Sep 2018
- Last updated
- 10 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Children With Developmental Coordination Disorder (DCD) Before the Age of Six: a Follow-up Study
- ClinicalTrials.gov ID
- NCT03690843
- Acronym / sponsor ID
- B670201837290
- Conditions
- Developmental Coordination Disorder
- Keywords
- motor development, toddler, prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023 (actual)
- First posted
- 1 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DCD Group | – | Other: Test BatteryChildren diagnosed with DCD or at-risk DCD at two or three years of age |
| Control Group | – | Other: Test BatteryTypically developing children |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children attending the Center of Developmental Disabilities Ghent.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Test BatteryAlso: Movement Assessment Battery for Children 2, Beery-VMI-6, Functional Strength Measurement, Child Behaviour ChecklistAll 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 | Control Group, DCD Group |
Primary outcome
Developmental Coordination Disorder
Time frame: This will be assessed at the age of 5 years.
Presence or absence of a diagnosis of DCD as defined by the DSM-V diagnostic criteria.
11 secondary outcomes
Movement Assessment Battery For children 2 - Dutch Version
Time frame: This will be assessed at the age of 3, 4 and 5 years.
Beery-Buktenica Developmental test of Visual-Motor Integration 6
Time frame: This will be assessed at the age of 3, 4 and 5 years.
Child Behaviour CheckList
Time frame: This will be assessed at the age of 3, 4 and 5 years.
Functional Strength Measurement
Time frame: This will be assessed at the age of 4 and 5 years.
Young Children's Participation and Environment Measure
Time frame: This will be assessed at the age of 3, 4 and 5 years.
Little-DCD-Questionnaire
Time frame: This will be assessed at the age of 3, 4 and 5 years.
Motor Skills Checklist (VMVK)
Time frame: This will be assessed at the age of 3, 4 and 5 years.
DCD-Daily Questionnaire
Time frame: This will be assessed at the age of 5 years.
Body Mass Index
Time frame: This will be assessed at the age of 3, 4 and 5 years.
Social Communication Questionnaire
Time frame: This will be assessed at the age of 5 years.
Teacher report form
Time frame: This will be assessed at the age of 3, 4 and 5 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Roubaix principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Coordination Disorder, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Developmental Coordination Disorder (time frame: This will be assessed at the age of 5 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2023.