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Observational Study of Psychomotor Development in Children Born in France to Parents Born in Sub-Saharan Africa.

NCT07191691 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2025-09-25

No results posted yet for this study

Summary

The goal of this observational study is to determine whether there are specific characteristics of psychomotor development in children born in France to parents born in Sub-Saharan Africa, using the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4).

The main question it aims to answer :

Is there a difference in the average raw scores on the motor scale between children born in France to parents from Sub-Saharan Africa and the French standard of the Bayley-4?

Child participants will be included in the study, and their parents will complete a socio-demographic questionnaire. The children will then be observed by the investigator in an enriched environment for 60 to 90 minutes. If necessary, the investigator may provide verbal stimulation.

The children will not be physically manipulated by the investigator, and breaks may be taken at any time as needed. Once the observation is complete, the participant's involvement in the study will end.

Conditions

  • Psychomotor Performance
  • Child Development
  • Culture

Interventions

DIAGNOSTIC_TEST

Bayley Scales of Infant and toddler Development, fourth edition (BSID-4)

The BSID-4 is a test that evaluates three areas of child's development, divided into three scales: * The Motor Scale, which includes the fine motor and gross motor subtests; * The Cognitive Scale, which consists of items assessing sensorimotor development, object exploration and manipulation, concept formation, memory, and other primary functions from which the child's reasoning abilities emerge; * The Language Scale, which includes the receptive communication and expressive communication subtests. The administration of the BSID-4 involves the standardized delivery of items. The BSID-4 standardization does not specify a fixed order for administering the scales: depending on the child's temperament and spontaneous interest, the examiner adapts the order in which the motor, language, and cognitive scales are administered.

Sponsors & Collaborators

  • Etablissement Public de Santé Barthélemy Durand

    lead OTHER

Principal Investigators

  • Camille Aguillon · Établissement Public de Santé Barthélemy Durand

Eligibility

Min Age
16 Days
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-06
Primary Completion
2027-09-30
Completion
2027-09-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07191691 on ClinicalTrials.gov