NCT07353112

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

28 days

First QC Date

December 13, 2025

Last Update Submit

January 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • SOSI-M score

    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.

Study Arms (2)

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.

Interventions

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.

Children with a neurotypical developmentChildren with neurodevelopmental disorders (NDD)

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • neurodevelopmental disorder (NDD)
  • speak french and understand instructions in French
  • and have not been assessed with the SOSI-M in the past 6 months.

You may not qualify if:

  • Severe motor/cognitive impairment
  • uncorrected visual/auditory impairment
  • cerebral palsy diagnosis
  • For the neurotypical children :
  • \- speak french and understand french instructions
  • diagnostic of musculoskeletal condition or neurodevelopmental or neurological condition
  • health condition that contraindicates taking the SOSI-M

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

December 13, 2025

First Posted

January 20, 2026

Study Start

February 1, 2026

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

January 20, 2026

Record last verified: 2026-01