NCT05617586

Brief Summary

The aim of this study is to map the early development of children with DCD and the diagnostic trajectory in Flanders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
10 months until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

3 years

First QC Date

January 7, 2019

Last Update Submit

November 14, 2022

Conditions

Developmental Coordination Disorder

Keywords

Early DevelopmentDiagnostic trajectoryParental reportQualitative study

Outcome Measures

Primary Outcomes (3)

  • Early Developmental characteristics of children with DCD during pregnancy (qualitative research) by means of an interview.

    As we will conduct a qualitative narrative analysis of the interviews, no standardised measurement tools will be used. We will probe for the following fields of interest: \- Pregnancy:(fetal movements, birth complications)

    20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020

  • Early Developmental characteristics of children with DCD during toddlerhood (qualitative research) by means of an interview.

    As we will conduct a qualitative narrative analysis of the interviews, no standardised measurement tools will be used. We will probe for the following fields of interest: \- Todderhood (feeding, cyring, sleeping, milestones, behavior, play)

    20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020

  • Early Developmental characteristics of children with DCD (preschooler) (qualitative research) by means of an interview.

    As we will conduct a qualitative narrative analysis of the interviews, no standardised measurement tools will be used. We will probe for the following fields of interest: \- Preschooler (interests, motor activities, behavior, friends, fatigue, communication, play)

    20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020

Secondary Outcomes (1)

  • Diagnostic trajectories of children with DCD in Flanders by means of an interview.

    20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020

Study Arms (1)

DCD Parents

An in-depth interview will be conducted of parents of a child with DCD. Parents will be asked to complete a Developmental Coordination Disorder Questionnaire (DCD-Q).

Other: In-depth parental interviewOther: Developmental Coordination Disorder Questionnaire (DCD-Q)

Interventions

In-depth parental interviewOTHER

A semi-structurerd interview will be conducted of parents with a child diagnosed with DCD. The interview will be audio-recorderded. The audiofile will be transcribed ad-verbatim and analyzed using narrative analysis methods.

DCD Parents
Developmental Coordination Disorder Questionnaire (DCD-Q)OTHER

Parents will be asked to complete the DCD-Q. This will help us describe the sample.

DCD Parents

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parents of children with DCD

You may qualify if:

  • Parent or guardian of a child diagnosed with DCD
  • Diagnosis of DCD within the last two years
  • Child was max. 12y of age at the moment of DCD diagnosis

You may not qualify if:

  • No severe diseases in early childhood greatly impacting development (cancer, severe accident,…)
  • Diagnosis outside of Belgium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Motor Skills Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Amy De Roubaix, Master

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Hilde Van Waelvelde, PhD

    University Ghent

    STUDY CHAIR

  • Dominique Van De Velde, PhD

    University Ghent

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

January 7, 2019

First Posted

November 15, 2022

Study Start

January 15, 2019

Primary Completion

January 25, 2022

Study Completion

January 25, 2022

Last Updated

November 15, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)