Neurodevelopmental DisordersNCT07353112
Validation of the French Translation of the SOSI-M
A study testing Administration of the French translation of the SOSI-M test. in people with Neurodevelopmental Disorders, run by Haute Ecole Ilya Prigogine.
Trial summary
The aim of this study is to validate the French version of the SOSI-M test on healthy children as well as on children with neurodevelopmental disorders (NDDs). Therefore, the investigators will conduct a video recording of the test administration on a group of healthy children and on a group of children with NDDs. Read more about this study
- Who is it for?
- Ages 5 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- Administration of the French translation of the SOSI-M test.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- neurodevelopmental disorder (NDD)
- speak french and understand instructions in French
- and have not been assessed with the SOSI-M in the past 6 months.
- speak french and understand french instructions
Who cannot join
- Severe motor/cognitive impairment
- uncorrected visual/auditory impairment
- cerebral palsy diagnosis
- For the neurotypical children :
- diagnostic of musculoskeletal condition or neurodevelopmental or neurological condition
- health condition that contraindicates taking the SOSI-M
About this study
Official title: Validation of the French Translation of SOSI-M in Healthy Children and in Children With Mild to Moderate Neurodevelopmental Disorder
The aim of this study is to validate the French version of the SOSI-M test on healthy children as well as on children with neurodevelopmental disorders (NDDs).
Therefore, the investigators will conduct a video recording of the test administration on a group of healthy children and on a group of children with NDDs.
Read more
The research question is: Is the French translation of the SOSI-M test equivalent, in terms of functionality and expected results, to the original version for a population of healthy children and children with mild to moderate neurodevelopmental disorders?
The hypothesis is that the psychometric properties of the French version are similar to those of the original version.
Secondly, the investigators will investigate: Does the difference in socio-cultural context between healthy Belgian and Senegalese children influence the SOSI-M score?
The hypothesis is that healthy Belgian children obtain better scores compared to healthy Senegalese children.
The scores of the two groups will be compared with each other and with those obtained in previous studies. Intra- and inter-rater reliability will also be assessed.
- Conditions
- Neurodevelopmental Disorders
- Being tested
- Administration of the French translation of the SOSI-M test.
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of the French translation of the SOSI-M test.Diagnostic test
Filmed administration of the French translation of the SOSI-M test
We will then compare the scores of the two groups between them and with the scores obtained by other studies.
There will be two operators that will evaluate each video 2 times (3 weeks between each evaluation) in order to mesure the metrologics qualities like fidelity.
| Study group | Role | What they receive |
|---|---|---|
| Children with neurodevelopmental disorders (NDD) | Experimental | Not described Receives: Diagnostic Test: Administration of the French translation of the SOSI-M test. |
| Children with a neurotypical development | Experimental | Not described Receives: Diagnostic Test: Administration of the French translation of the SOSI-M test. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOSI-M score
For the total raw score :
0 = Abnormal 64 = Normal development of the child
Measured: 1 day for the filmed passation of the french version of the sosi-m test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haute Ecole Ilya Prigogine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Villa Lelia, Haute Ecole Ilya Prigogine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07353112
- Sponsor's protocol ID
- HUB2025977
- Status last verified
- Jan 2026
- First submitted
- 13 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Translation of SOSI-M in Healthy Children and in Children With Mild to Moderate Neurodevelopmental Disorder
- ClinicalTrials.gov ID
- NCT07353112
- Acronym / sponsor ID
- HUB2025977
- Conditions
- Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haute Ecole Ilya PrigogineUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 20 Jan 2026 (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 validate the French version of the SOSI-M test on healthy children as well as on children with neurodevelopmental disorders (NDDs).
Therefore, the investigators will conduct a video recording of the test administration on a group of healthy children and on a group of children with NDDs.
The research question is: Is the French translation of the SOSI-M test equivalent, in terms of functionality and expected results, to the original version for a population of healthy children and children with mild to moderate neurodevelopmental disorders?
The hypothesis is that the psychometric properties of the French version are similar to those of the original version.
Secondly, the investigators will investigate: Does the difference in socio-cultural context between healthy Belgian and Senegalese children influence the SOSI-M score?
The hypothesis is that healthy Belgian children obtain better scores compared to healthy Senegalese children.
The scores of the two groups will be compared with each other and with those obtained in previous studies. Intra- and inter-rater reliability will also be assessed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with neurodevelopmental disorders (NDD) | Experimental | Diagnostic Test: Administration of the French translation of the SOSI-M test. |
| Children with a neurotypical development | Experimental | Diagnostic Test: Administration of the French translation of the SOSI-M test. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- neurodevelopmental disorder (NDD)
- speak french and understand instructions in French
- and have not been assessed with the SOSI-M in the past 6 months.
- speak french and understand french instructions
Key exclusion criteria (6 listed)
- Severe motor/cognitive impairment
- uncorrected visual/auditory impairment
- cerebral palsy diagnosis
- diagnostic of musculoskeletal condition or neurodevelopmental or neurological condition
- health condition that contraindicates taking the SOSI-M
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 |
|---|---|---|
| Administration of the French translation of the SOSI-M test.Filmed administration of the French translation of the SOSI-M test We will then compare the scores of the two groups between them and with the scores obtained by other studies. There will be two operators that will evaluate each video 2 times (3 weeks between each evaluation) in order to mesure the metrologics qualities like fidelity. | Diagnostic test | Children with a neurotypical development, Children with neurodevelopmental disorders (NDD) |
Primary outcome
SOSI-M score
Time frame: 1 day for the filmed passation of the french version of the sosi-m test.
For the total raw score : 0 = Abnormal 64 = Normal development of the child
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
Related trials for Neurodevelopmental Disorders
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Administration of the French translation of the SOSI-M test. in people with Neurodevelopmental Disorders, run by Haute Ecole Ilya Prigogine.
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 6 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: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
SOSI-M score (time frame: 1 day for the filmed passation of the french version of the sosi-m test.). 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 20 Jan 2026.