Developmental Coordination DisorderSocial_DCDNCT05092893
Social Skills in Children With Developmental Coordination Disorder (DCD)
An observational study of Developmental Coordination Disorder, run by University Ghent at 1 site in Belgium.
Trial summary
In this study we will examine the social-communicative skills of children with Developmental Coordination Disorder (DCD) by using online parental questionnaires in children aged 5 to 15y. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Online parental questionnaires
- How many people
- 175 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Sep 2021to 18 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 5 to 15 years
- All sexes
- Child
Study population: All children diagnosed with DCD in Belgium and The Netherlands between 5 and 15y.
Who may be able to join
- Confirmed diagnosis of DCD
- Comorbidities are allowed (f.e. ASD, ADHD, ADD,…)
Who cannot join
- Any other neurodevelopmental disorder which might affect motor development (f.e. CP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Social Skills in Children With Developmental Coordination Disorder (DCD): a Cross-sectional Study
In this study we will examine the social-communicative skills of children with Developmental Coordination Disorder (DCD) by using online parental questionnaires in children aged 5 to 15y.
Read the detailed description
Developmental Coordination Disorder (DCD) is a neurodevelopmental disorder described in the DSM-V characterized by motor coordination problems which significantly interfere with daily living activities and participation. The problems cannot be explained by another disorder and are already present in early life.
Although DCD is a 'motor' disorder, other domains may equally be affected. Children with DCD show lower health-related quality of life, more socio-emotional problems, and experience more academic difficulties. It has been proposed that social skills may mediate the emergence of socio-emotional problems at a later age. Previous research has suggested that socials skills of children with DCD may be altered. However, the process remains unclear. One possible hypothesis is that early motor coordination problems leads to avoiding or inhibits age-appropriate physical and social activities, which may reduce the opportunities to develop adequate socials skills and/or may impact negatively on a child's developing self-esteem and create a sense of isolation and exclusion.
Indeed, it has been reported that these children spend more time playing alone and are often onlookers instead of actively engaging in play. In general they exhibit a lower participation rate which may contribute to the reported poorer peer relations, less (deep) friendships, and a tendency for more bullying and loneliness. They also feel less competent in peer and social relations. Poorer social interaction skills and more social communication problems have been recognized in these children even interfering in non-verbal skills such as poorer recognizing of facial expressions and emotions and a reduced tendency to follow gaze which may be similar to children with ASD.
It can be debated if these social problems are comorbid or rather a secondary consequence.
With this study the investigators aim to map social responsiveness problems in children with Developmental Coordination Disorder and clarify if and which domains are most affected. The investigators defined the following research question: "Do children with Developmental Coordination Disorder experience social responsiveness problems compared to typically developing children? If so, which domains are most affected?".
- Conditions
- Developmental Coordination Disorder
- Being tested
- Online parental questionnaires
- Keywords
- Children, Social communication
- Medical subject headings
- Motor Skills Disorders, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online parental questionnairesOther
The SRS-2 is a parental 65-item questionnaire to detect difficulties in social responsiveness in children with autism spectrum disorder. Four different forms are available: preschoolers (2.5-4.5 years), school-aged children (4-18 years), adults (≥ 19 years) and adults self-report. In this study, only the form for school-aged children will be used.
The DCDQ'07 is a parental 15-item questionnaire to detect the risk of DCD in children between 5 and 15 years of age. Parents are asked to compare their child's motor performance to his/her peers using a 5-point Likert scale. The total sum score is compared to age-specific cut-off scores to determine the risk of DCD. Belgian norms are available since 2007.
| Study group | Role | What they receive |
|---|---|---|
| Children with Developmental Coordination Disorder | INCLUSION:
* Confirmed diagnosis of DCD
* Comorbidities are allowed (f.e. ASD, ADHD, ADD,…)
EXCLUSION:
o Any other neurodevelopmental disorder which might affect motor development (f.e. CP). Receives: Other: Online parental questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Questionnaire
Outcomes are reported in a total score and five subscales (social awareness, social cognition, social communication, social motivation and restricted interests and repetitive behavior).
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start28 Sep 2021
- Primary completion18 Jan 2022
- Study completion18 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Developmental Coordination DisorderStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominique Van de Velde, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092893
- Sponsor's protocol ID
- b6702021000688
- Acronym
- Social_DCD
- Status last verified
- Aug 2021
- First submitted
- 26 Aug 2021
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Roubaix A, Roeyers H, Van Waelvelde H, Bar-On L. Social responsiveness in children with developmental coordination disorder. Braz J Phys Ther. 2024 Jan-Feb;28(1):100591. doi: 10.1016/j.bjpt.2024.100591. Epub 2024 Feb 9.
PubMed 38394720
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Skills in Children With Developmental Coordination Disorder (DCD): a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT05092893
- Acronym / sponsor ID
- Social_DCD / b6702021000688
- Conditions
- Developmental Coordination Disorder
- Keywords
- Children, Social communication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 18 Jan 2022 (actual)
- Study completion
- 18 Jan 2022 (actual)
- First posted
- 26 Oct 2021 (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.
In this study we will examine the social-communicative skills of children with Developmental Coordination Disorder (DCD) by using online parental questionnaires in children aged 5 to 15y.
Detailed description
Developmental Coordination Disorder (DCD) is a neurodevelopmental disorder described in the DSM-V characterized by motor coordination problems which significantly interfere with daily living activities and participation. The problems cannot be explained by another disorder and are already present in early life.
Although DCD is a 'motor' disorder, other domains may equally be affected. Children with DCD show lower health-related quality of life, more socio-emotional problems, and experience more academic difficulties. It has been proposed that social skills may mediate the emergence of socio-emotional problems at a later age. Previous research has suggested that socials skills of children with DCD may be altered. However, the process remains unclear. One possible hypothesis is that early motor coordination problems leads to avoiding or inhibits age-appropriate physical and social activities, which may reduce the opportunities to develop adequate socials skills and/or may impact negatively on a child's developing self-esteem and create a sense of isolation and exclusion.
Indeed, it has been reported that these children spend more time playing alone and are often onlookers instead of actively engaging in play. In general they exhibit a lower participation rate which may contribute to the reported poorer peer relations, less (deep) friendships, and a tendency for more bullying and loneliness. They also feel less competent in peer and social relations. Poorer social interaction skills and more social communication problems have been recognized in these children even interfering in non-verbal skills such as poorer recognizing of facial expressions and emotions and a reduced tendency to follow gaze which may be similar to children with ASD.
It can be debated if these social problems are comorbid or rather a secondary consequence.
With this study the investigators aim to map social responsiveness problems in children with Developmental Coordination Disorder and clarify if and which domains are most affected. The investigators defined the following research question: "Do children with Developmental Coordination Disorder experience social responsiveness problems compared to typically developing children? If so, which domains are most affected?".
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Developmental Coordination Disorder | – | Other: Online parental questionnairesINCLUSION: * Confirmed diagnosis of DCD * Comorbidities are allowed (f.e. ASD, ADHD, ADD,…) EXCLUSION: o Any other neurodevelopmental disorder which might affect motor development (f.e. CP). |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- All children diagnosed with DCD in Belgium and The Netherlands between 5 and 15y.
Key inclusion criteria (2 listed)
- Confirmed diagnosis of DCD
- Comorbidities are allowed (f.e. ASD, ADHD, ADD,…)
Key exclusion criteria (1 listed)
- Any other neurodevelopmental disorder which might affect motor development (f.e. CP).
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 |
|---|---|---|
| Online parental questionnairesThe SRS-2 is a parental 65-item questionnaire to detect difficulties in social responsiveness in children with autism spectrum disorder. Four different forms are available: preschoolers (2.5-4.5 years), school-aged children (4-18 years), adults (≥ 19 years) and adults self-report. In this study, only the form for school-aged children will be used. The DCDQ'07 is a parental 15-item questionnaire to detect the risk of DCD in children between 5 and 15 years of age. Parents are asked to compare their child's motor performance to his/her peers using a 5-point Likert scale. The total sum score is compared to age-specific cut-off scores to determine the risk of DCD. Belgian norms are available since 2007. | Other | Children with Developmental Coordination Disorder |
Primary outcome
Social Responsiveness Questionnaire
Time frame: through study completion, an average of 6 months
Outcomes are reported in a total score and five subscales (social awareness, social cognition, social communication, social motivation and restricted interests and repetitive behavior).
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 8 Aug 2022.
- Derived from this study: PubMed 38394720De Roubaix A, Roeyers H, Van Waelvelde H, Bar-On L. Social responsiveness in children with developmental coordination disorder. Braz J Phys Ther. 2024 Jan-Feb;28(1):100591. doi: 10.1016/j.bjpt.2024.100591. Epub 2024 Feb 9.
- Individual participant dataSharing planned: No
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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.
Dominique Van de Velde principal investigator
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 2 inclusion and 1 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 8 Aug 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?
Social Responsiveness Questionnaire (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05092893, which also lists 1 linked publication.
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 8 Aug 2022.