Validation of the French Translation of the SOSI-M
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Administration of the French translation of the SOSI-M test..
- Who it may be relevant to
- Registry conditions: Neurodevelopmental Disorders. Basic parameters: 5 years — 14 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Validation of the French Translation of SOSI-M in Healthy Children and in Children With Mild to Moderate Neurodevelopmental Disorder
Overview
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.
Interventions
- Diagnostic test 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.
Primary outcome measures
- SOSI-M score [Time frame: 1 day for the filmed passation of the french version of the sosi-m test.]
Eligibility criteria
For the groupe of children with neurodevelopmental disorders :
Inclusion criteria
- neurodevelopmental disorder (NDD)
- speak french and understand instructions in French
- and have not been assessed with the SOSI-M in the past 6 months.
Exclusion criteria
- Severe motor/cognitive impairment
- uncorrected visual/auditory impairment
- cerebral palsy diagnosis
For the neurotypical children :
Inclusion criteria
\- speak french and understand french instructions
Exclusion criteria
- diagnostic of musculoskeletal condition or neurodevelopmental or neurological condition
- health condition that contraindicates taking the SOSI-M
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07353112 · HUB2025977