Validation of the French Translation of the SOSI-M

Официальное название

Validation of the French Translation of SOSI-M in Healthy Children and in Children With Mild to Moderate Neurodevelopmental Disorder

Обзор

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• SOSI-M score [Срок оценки: 1 day for the filmed passation of the french version of the sosi-m test.]

Критерии участия

For the groupe of children with neurodevelopmental disorders :

Критерии включения

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

Критерии исключения

• Severe motor/cognitive impairment
• uncorrected visual/auditory impairment
• cerebral palsy diagnosis

For the neurotypical children :

Критерии включения

\- speak french and understand french instructions

Критерии исключения

• diagnostic of musculoskeletal condition or neurodevelopmental or neurological condition
• health condition that contraindicates taking the SOSI-M

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07353112 · HUB2025977

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗