NCT04126395

Brief Summary

This study compares motor development in three groups of infants (controls, DCD, DCD+ASD) before the age of 2 years using retrospective video analysis of infants in home video contexts.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
2 countries

2 active sites

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

October 11, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 15, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

September 14, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2023

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

October 11, 2019

Last Update Submit

February 20, 2024

Conditions

Keywords

motor developmentbabyinfantmotor milestonescrawlingindependent walking

Outcome Measures

Primary Outcomes (1)

  • Observable Movement Quality Scale

    The OMQ is a standardized 15-item observational scale to asses the movement quality. A maximum of two 5-minute compilations are assembled per child per age-category (6-12 months, 12-18 monhts, 18-24 months)

    0-2years

Study Arms (3)

Controls

This groups consists of children now aged 6-12y: * Without a medical diagnosis possibly influencing motor development * Without motor problems (M-ABC-2 and DCD-Q) * Without social reponsiveness problems (SRS-2)

Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2)Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q)Diagnostic Test: Social Responsiveness Scale 2 (SRS-2)Other: Retrospective Video Analysis

Developmental Coordination Disorder

This groups consists of children now aged 6-12y: * With a multidisciplinary diagnosis of DCD * With motor problems (M-ABC-2 and DCD-Q)

Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2)Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q)Diagnostic Test: Social Responsiveness Scale 2 (SRS-2)Other: Retrospective Video Analysis

Developmental Coordination Disorder + Autism Spectrum Disorder

This groups consists of children now aged 6-12y: * With a multidisciplinary diagnosis of DCD * With motor problems (M-ABC-2 and DCD-Q) * With social responsiveness problems (SRS-2)

Diagnostic Test: Movement Assessment Battery for Children 2(M-ABC-2)Diagnostic Test: Developmental Coordination Disorder - Questionnaire (DCD-Q)Diagnostic Test: Social Responsiveness Scale 2 (SRS-2)Other: Retrospective Video Analysis

Interventions

The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age. We will use Dutch-Flemish norms.

ControlsDevelopmental Coordination DisorderDevelopmental Coordination Disorder + Autism Spectrum Disorder

The DCD-Q is a brief parent questionnaire designed to screen for the presence of DCD in children aged 5 trough 15 years of age. We will use Dutch norms.

ControlsDevelopmental Coordination DisorderDevelopmental Coordination Disorder + Autism Spectrum Disorder

The SRS-2 is a parent questionnaire designed to identify social impairments associated with ASD in children 4 trough 18 years of age. We will used Dutch norms.

ControlsDevelopmental Coordination DisorderDevelopmental Coordination Disorder + Autism Spectrum Disorder

Retrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls.

ControlsDevelopmental Coordination DisorderDevelopmental Coordination Disorder + Autism Spectrum Disorder

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Availability of video material of the child before the age of 2.
  • No indication of DCD (as measured by M-ABC-2 Pc\>16 and DCD-Q)
  • No indication of ASD (as measured by SRS-2 T-score ≤60 )

You may not qualify if:

  • Medical diagnosis possibly influencing motor development (DCD, ASD, ADHD, CP, ect)
  • Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
  • Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)
  • DCD GROUP:
  • Availability of video material of the child before the age of 2.
  • Formal diagnosis of DCD provided by multidisciplinary team in Flanders
  • Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)
  • Other medical diagnosis possibly influencing motor development (ASD, ADHD, CP, ect)
  • Severe ilnesses in the early Developmental period (0-2y) which may have influenced the development (f.e. CVA, cancer, severe traumas,...)
  • Prolonged admission to the hospital (≥ 3 weeks) in the early Developmental period (0-2y)
  • DCD+ASD GROUP:
  • Availability of video material of the child before the age of 2.
  • Formal diagnosis of DCD and ASD provided by multidisciplinary team in Flanders
  • Indication of DCD (as measured by M-ABC-2 Pc≤16 and DCD-Q)
  • Indication of ASD (as measured by SRS-2 T-score \>60 )
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ghent University

Ghent, 9000, Belgium

Location

UBC

Vancouver, Canada

Location

MeSH Terms

Conditions

Motor Skills DisordersAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental DisordersChild Development Disorders, Pervasive

Study Officials

  • Hilde Van Waelvelde, Dr.

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 11, 2019

First Posted

October 15, 2019

Study Start

September 14, 2020

Primary Completion

July 25, 2023

Study Completion

July 25, 2023

Last Updated

February 22, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations