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Trial record 10 of 16 for:    for Children | "Developmental Dyspraxia"

Development of Children With DCD Before the Age of Six

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ClinicalTrials.gov Identifier: NCT03690843
Recruitment Status : Recruiting
First Posted : October 1, 2018
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick Van Gelder, University Ghent

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.


Condition or disease Intervention/treatment
Developmental Coordination Disorder Other: Test Battery

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.


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Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Development of Children With Developmental Coordination Disorder (DCD) Before the Age of Six: a Follow-up Study
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : February 2023

Group/Cohort Intervention/treatment
DCD Group
Children diagnosed with DCD or at-risk DCD at two or three years of age
Other: Test Battery
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:
  • Movement Assessment Battery for Children 2
  • Beery-VMI-6
  • Functional Strength Measurement
  • Child Behaviour Checklist
  • Little-DCD-Questionnaire
  • DCD-Daily
  • DCD-Daily-Questionnaire
  • Vragenlijst motorische vaardigheden kleuters
  • Body mass Index
  • YC-PEM
  • Social Communication Questionnaire

Control Group
Typically developing children
Other: Test Battery
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:
  • Movement Assessment Battery for Children 2
  • Beery-VMI-6
  • Functional Strength Measurement
  • Child Behaviour Checklist
  • Little-DCD-Questionnaire
  • DCD-Daily
  • DCD-Daily-Questionnaire
  • Vragenlijst motorische vaardigheden kleuters
  • Body mass Index
  • YC-PEM
  • Social Communication Questionnaire




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Movement Assessment Battery For children 2 - Dutch Version [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]
    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.

  2. Beery-Buktenica Developmental test of Visual-Motor Integration 6 [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]
    The Beery-VMI-6 measures the visual-motor integration skills and consists of three subtests (visual-motor integration, motor coordination and visual perception).

  3. Child Behaviour CheckList [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]

    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.


  4. Functional Strength Measurement [ Time Frame: This will be assessed at the age of 4 and 5 years. ]
    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).

  5. Young Children's Participation and Environment Measure [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]
    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).

  6. Little-DCD-Questionnaire [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]
    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.

  7. Motor Skills Checklist (VMVK) [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]
    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.

  8. DCD-Daily(Questionnaire) [ Time Frame: This will be assessed at the age of 5 years. ]

    The DCD Daily is a test consisting of 18 ADL-activities Norms are available for children age 5 to 8y. Scores are based on success (3-point scale) and time (3-point scale).

    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).


  9. Body Mass Index [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]
    Height and weight will be determined.

  10. Social Communication Questionnaire [ Time Frame: This will be assessed at the age of 5 years. ]
    SCQ is a parental screening questionnaire for autism in children aged 4 years or older. The questionnaire consists of 40 yes/no questions.



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children attending the Center of Developmental Disabilities Ghent.
Criteria

Inclusion Criteria DCD group:

  1. 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.
  2. At least one parent speaks Dutch to the child

Inclusion Criteria controlgroup:

  1. The child is three years of age at the moment of the first testing
  2. Little-DCD-Q score ≥ 55 at 3y
  3. M-ABC-2 percentilescore ≥25 at 3y
  4. No medical diagnoses possibly influencing the motor development (DCD, ADHD, ASS, CP,…)
  5. No history of developmental motor stimulation (therapy) and/or support
  6. Gestational age ≥37w
  7. Birthweight ≥2500g
  8. At least one parent speaks Dutch to the child

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03690843


Contacts
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Contact: Amy De Roubaix 003293324657 amy.deroubaix@ugent.be
Contact: Hilde Van Waelvelde hilde.vanwaelvelde@ugent.be

Locations
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Belgium
Ghent University Recruiting
Ghent, Belgium, 9000
Contact: Amy Roubaix, PhD Candidate       amy.deroubaix@ugent.be   
Sponsors and Collaborators
University Ghent
Investigators
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Principal Investigator: Amy Roubaix University Ghent

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Responsible Party: Patrick Van Gelder, Doctoral student, University Ghent
ClinicalTrials.gov Identifier: NCT03690843     History of Changes
Other Study ID Numbers: B670201837290
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick Van Gelder, University Ghent:
motor development
toddler
prediction

Additional relevant MeSH terms:
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Motor Skills Disorders
Neurodevelopmental Disorders
Mental Disorders