Developmental Coordination DisorderDCD_ParentNCT05617586
Early Development and Diagnostic Trajectories in DCD
An observational study of Developmental Coordination Disorder, run by University Ghent at 1 site in Belgium.
Trial summary
The aim of this study is to map the early development of children with DCD and the diagnostic trajectory in Flanders. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- In-depth parental interview and Developmental Coordination Disorder Questionnaire (DCD-Q)
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2019to 25 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Parents of children with DCD
Who may be able to join
- 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
Who cannot join
- No severe diseases in early childhood greatly impacting development (cancer, severe accident,…)
- Diagnosis outside of Belgium
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Development and Diagnostic Trajectories in the Child With DCD in Flanders
The aim of this study is to map the early development of children with DCD and the diagnostic trajectory in Flanders.
Read the 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.
- Conditions
- Developmental Coordination Disorder
- Being tested
- In-depth parental interview, Developmental Coordination Disorder Questionnaire (DCD-Q)
- Keywords
- Early Development, Diagnostic trajectory, Parental report, Qualitative study
- Medical subject headings
- Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Developmental Coordination Disorder Questionnaire (DCD-Q)Other
Parents will be asked to complete the DCD-Q. This will help us describe the sample.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: In-depth parental interview; Other: Developmental Coordination Disorder Questionnaire (DCD-Q) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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.
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:
- Did parents/creche/family/friends/school express concerns which have led to seeking advice/help? Which concerns?
- Which advises or what help did parents receive from who? What did they do with them?
- Which caregivers did they consult? What were the results/advices?
- Who diagnosed the child with DCD? Who was involved?
- Which elements led to the diagnosis of DCD?
We will map the trajectories leading to a diagnosis of DCD in Flanders.
Measured: 20 interviews (duration: approximately 1.5 to 2 hours) starting from january 2019 to december 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start15 Jan 2019
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy De Roubaix, Master, Principal investigator, University GhentHilde Van Waelvelde, PhD, Study chair, University GhentDominique Van De Velde, PhD, Study chair, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617586
- Sponsor's protocol ID
- B670201836914
- Acronym
- DCD_Parent
- Status last verified
- Nov 2022
- First submitted
- 7 Jan 2019
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Development and Diagnostic Trajectories in the Child With DCD in Flanders
- ClinicalTrials.gov ID
- NCT05617586
- Acronym / sponsor ID
- DCD_Parent / B670201836914
- Conditions
- Developmental Coordination Disorder
- Keywords
- Early Development, Diagnostic trajectory, Parental report, Qualitative study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to map the early development of children with DCD and the diagnostic trajectory in Flanders.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DCD Parents | – | Other: In-depth parental interview, Other: Developmental Coordination Disorder Questionnaire (DCD-Q)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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parents of children with DCD
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- No severe diseases in early childhood greatly impacting development (cancer, severe accident,…)
- Diagnosis outside of Belgium
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-depth parental interviewA 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. | Other | DCD Parents |
| Developmental Coordination Disorder Questionnaire (DCD-Q)Parents will be asked to complete the DCD-Q. This will help us describe the sample. | Other | DCD Parents |
Primary outcome
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
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)
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)
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
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)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Developmental Coordination Disorder
Not yet recruiting
Video-Assisted Core Stabilization Exercises in Children With Developmental Coordination Disorder
Developmental Coordination Disorder (DCD)
Enrolling by invitation
BEhavioral Health Stratified Treatment (BEST) Study for Youth With Intellectual and/or Developmental Disabilities (IDD)
Depression, Anxiety
Not yet recruitingObservational study
Wearable Sensor Toolkit for Infant Motor Development
Motor Delay, Infant Development
Not yet recruiting
Neuromotor Task Training in Autistic Children With Motor Difficulties
Autism Spectrum Disorder (ASD)
Enrolling by invitationObservational study
Investigating the Relationship Between Motor Challenges and Postural Stability in ASD
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy De Roubaix, Master principal investigator
University Ghent
Hilde Van Waelvelde, PhD study chair
University Ghent
Dominique Van De Velde, PhD study chair
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Coordination Disorder, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022.