Validation of the French Translation of the SOSI-M

January 15, 2026 updated by: Villa Lelia, Haute Ecole Ilya Prigogine

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.

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Children with neurodevelopmental disorders (NDD)
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.
Experimental: Children with a neurotypical development
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day for the filmed passation of the french version of the sosi-m test.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haute Ecole Ilya Prigogine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

December 13, 2025

First Submitted That Met QC Criteria

January 15, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB2025977

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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