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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

Tracking Information
First Submitted Date September 27, 2018
First Posted Date October 1, 2018
Last Update Posted Date April 4, 2019
Actual Study Start Date October 8, 2018
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 28, 2018)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03690843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 28, 2018)
  • 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.
  • 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).
  • 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.
  • 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).
  • 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).
  • 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.
  • 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.
  • 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).
  • Body Mass Index [ Time Frame: This will be assessed at the age of 3, 4 and 5 years. ]
    Height and weight will be determined.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Development of Children With DCD Before the Age of Six
Official Title The Development of Children With Developmental Coordination Disorder (DCD) Before the Age of Six: a Follow-up Study
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.

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 Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Children attending the Center of Developmental Disabilities Ghent.
Condition Developmental Coordination Disorder
Intervention 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
Study Groups/Cohorts
  • DCD Group
    Children diagnosed with DCD or at-risk DCD at two or three years of age
    Intervention: Other: Test Battery
  • Control Group
    Typically developing children
    Intervention: Other: Test Battery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 28, 2018)
240
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Years to 5 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Amy De Roubaix 003293324657 amy.deroubaix@ugent.be
Contact: Hilde Van Waelvelde hilde.vanwaelvelde@ugent.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03690843
Other Study ID Numbers B670201837290
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Patrick Van Gelder, University Ghent
Study Sponsor University Ghent
Collaborators Not Provided
Investigators
Principal Investigator: Amy Roubaix University Ghent
PRS Account University Ghent
Verification Date April 2019