Developmental Coordination DisorderTOM_DCDNCT06183411
Theory of Mind in Children With DCD
A study testing Assessment in people with Developmental Coordination Disorder, run by University Ghent at 1 site in Belgium.
Trial summary
The aim of the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Developmental Coordination Disorder
- What is being tested?
- Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Nov 2023to 30 Oct 2024
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age of child: from six to 12 years old
- Confirmed diagnosis of DCD by a multidisciplinary team (including a physician)
- Child lives in Flanders or the Netherlands
- Child has Dutch as the mother tongue
Who cannot join
- Diagnosis of autism spectrum disorder (ASD)
- Blood related siblings of the child
- Parent/legal guardian does not have an adequate level of Dutch
- (IQ lower than 70) OR (no IQ information and child attends special education type 1 (mild intellectual disability) or type 2 (moderate to severe mental disability))
Trial locations and contacts
1 site in 1 country.
Lynn Bar-On, Prof. Dr. contact
Belgium1 site, 1 recruiting
- Recruiting
Universiteit Gent - Vakgroep revalidatiewetenschappen
Ghent
Lynn Bar-On
About this study
The aim of the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. In addition, children should be six until twelve years old with a DCD diagnosis confirmed by a multidisciplinary team (including a doctor).
During the test moment, ToM will be tested by ToM test-R and the motor skills by MABC-2. Beside, the ToM test-R will be filmed, but the child's face not shown. The parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, CVO, SRS-2, SDQ and ToMBC), this can be completed in advance at home or at the test moment (researchers provide a laptop).
- Conditions
- Developmental Coordination Disorder
- Being tested
- Assessment
- Keywords
- Child, Development, Theory of mind
- 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.
AssessmentBehavioural
- Observations using two valid, observational instruments (MABC-2 and ToM test-R) that each child completes once at random.
- A demographic and developmental questionnaire is completed once by the parent/guardian at recruitment.
- Standardized questionnaires (Coordination Questionnaire For Parents (CVO), Social Responsiveness Scale second edition (SRS-2), Strengths and Difficulties Questionnaire (SDQ) and Theory of Mind Behavior Checklist (ToMBC)) are also questioned once to parent/guardian for data collection.
| Study group | Role | What they receive |
|---|---|---|
| Children with DCD | Other | Not described Receives: Behavioral: Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Theory of Mind
Measured with ToM test-R andTheory of Mind Behavior Checklist (ToMBC)
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start17 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VakgroepRevalidatiewetenschappen, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183411
- Sponsor's protocol ID
- ONZ-2023-0329
- Acronym
- TOM_DCD
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 27 Dec 2023
- 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 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Theory of Mind in Children With DCD
- ClinicalTrials.gov ID
- NCT06183411
- Acronym / sponsor ID
- TOM_DCD / ONZ-2023-0329
- Conditions
- Developmental Coordination Disorder
- Keywords
- Child, Development, Theory of mind
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 17 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 27 Dec 2023 (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 the study is to investigate theory of mind (ToM) in children with developmental coordination disorder (DCD). Dutch-speaking children, who are living in Flanders or The Netherlands (because comparisons will be made with Flemish and Dutch norms), will be included. In addition, children should be six until twelve years old with a DCD diagnosis confirmed by a multidisciplinary team (including a doctor).
During the test moment, ToM will be tested by ToM test-R and the motor skills by MABC-2. Beside, the ToM test-R will be filmed, but the child's face not shown. The parent/legal guardian will be asked to complete five online questionnaires (demographic and developmental questionnaire, CVO, SRS-2, SDQ and ToMBC), this can be completed in advance at home or at the test moment (researchers provide a laptop).
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with DCD | Other | Behavioral: Assessment |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age of child: from six to 12 years old
- Confirmed diagnosis of DCD by a multidisciplinary team (including a physician)
- Child lives in Flanders or the Netherlands
- Child has Dutch as the mother tongue
Key exclusion criteria (4 listed)
- Diagnosis of autism spectrum disorder (ASD)
- Blood related siblings of the child
- Parent/legal guardian does not have an adequate level of Dutch
- (IQ lower than 70) OR (no IQ information and child attends special education type 1 (mild intellectual disability) or type 2 (moderate to severe mental disability))
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 |
|---|---|---|
| Assessment* Observations using two valid, observational instruments (MABC-2 and ToM test-R) that each child completes once at random. * A demographic and developmental questionnaire is completed once by the parent/guardian at recruitment. * Standardized questionnaires (Coordination Questionnaire For Parents (CVO), Social Responsiveness Scale second edition (SRS-2), Strengths and Difficulties Questionnaire (SDQ) and Theory of Mind Behavior Checklist (ToMBC)) are also questioned once to parent/guardian for data collection. | Behavioural | Children with DCD |
Primary outcome
Theory of Mind
Time frame: 2 hours
Measured with ToM test-R andTheory of Mind Behavior Checklist (ToMBC)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- 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.
Lynn Bar-On, Prof. Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assessment in people with 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynn Bar-On, Prof. Dr. (+3293326920, lynn.baron@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Theory of Mind (time frame: 2 hours). 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 27 Dec 2023.