- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05617586
Early Development and Diagnostic Trajectories in DCD (DCD_Parent)
Early Development and Diagnostic Trajectories in the Child With DCD in Flanders
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The Diagnostic and Statistical manual 5th edition (DSM-V) defines Developmental Coordination Disorder (DCD) as early-onset deficits in acquiring and executing motor coordination skills. These deficits significantly interfere with the performance of activities of daily living and impact on academic productivity, leisure and play.
Although DCD can be identified during preschool, diagnosis generally occurs at primary-school age. Before the age of three (t.i. infancy), some parents already express "something is wrong" with their child albeit DCD is rarely diagnosed within this age-group.
Knowledge on DCD in children before the age of five is limited. The aim of this study is twofold: to explore the early development of children with DCD and to map the diagnostic trajectory of DCD in Flanders.
Design: A qualitative narrative inductive study design by means of audio-recorded in-depth interviews
Sampling: Purposeful maximum variation sampling will be applied.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Ghent, Belgium, 9000
- Ghent University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- No severe diseases in early childhood greatly impacting development (cancer, severe accident,…)
- Diagnosis outside of Belgium
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
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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.
Parents will be asked to complete the DCD-Q.
This will help us describe the sample.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Developmental characteristics of children with DCD during pregnancy (qualitative research) by means of an interview.
Time Frame: 20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020
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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
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Early Developmental characteristics of children with DCD during toddlerhood (qualitative research) by means of an interview.
Time Frame: 20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020
|
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
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Early Developmental characteristics of children with DCD (preschooler) (qualitative research) by means of an interview.
Time Frame: 20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diagnostic trajectories of children with DCD in Flanders by means of an interview.
Time Frame: 20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020
|
As we will conduct a qualitative narrative analysis of the interviews, no standardised measurement tools will be used. We will probe for the following field of interest:
We will map the trajectories leading to a diagnosis of DCD in Flanders. |
20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amy De Roubaix, Master, University Ghent
- Study Chair: Hilde Van Waelvelde, PhD, University Ghent
- Study Chair: Dominique Van De Velde, PhD, University Ghent
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B670201836914
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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