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

NCT07191691 | Not Yet Recruiting

• 2 other identifiers: 22P022025-A00487-42
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Psychomotricity; Child Development; Culture; Migration; Bayley Scales of Infant and toddler Development

Outcome Measures

Primary Outcomes (1)

• Verify the existence of specific characteristics in the motor development of children born in France to parents born in Sub-Saharan Africa.

  The primary outcome is to determine whether there are any specific characteristics exist in the motor development of children born in France to parents from Sub-Saharan Africa by comparing their average raw scores on the BSID-4 motor scale with the the French norms.

  Between 60 and 90 minutes

Secondary Outcomes (1)

• Establish a developmental timeline for psychomotor skills in children born in France to parents born in Sub-Saharan Africa, based on 23 items from the early screening developmental norms provided by the government to early childhood professionals.

  Between 60 and 90 minutes

Study Arms (1)

Children born in France to parents born in Sub-Saharan Africa

Subject evaluation included during 60 to 90 minutes. Step 1: The investigator will complete a socio-demographic questionnaire based on the parents' responses. Step 2: The BSID-4 (Bayley Scales of Infant and Toddler Development, Fourth Edition) will be completed through observation of the child's behavior. Parents will remain with their child throughout the assessment. The test concludes after five consecutive failures on the final scale administered. Step 3: Subjects will exit the research protocol upon completion of the BSID-4 assessment.

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

Interventions

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

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.

Children born in France to parents born in Sub-Saharan Africa

Eligibility Criteria

• Age: 16 Days - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children subjects from 16 days to 24 months, born in France to parents born in Sub-Saharan Africa

You may qualify if:

• Both parents born in a geographically homogeneous area: Sub-Saharan African countries
• Children with no known medical conditions
• Born between 37 and 42 weeks of gestational age
• Birth weight equal to or greater than 2.5 kg
• Apgar score of 10 at 5 minutes after birth
• No objection from the holders of parental authority to the collection of data

You may not qualify if:

• Not Applicable

Sponsors & Collaborators

• Etablissement Public de Santé Barthélemy Durand: lead

Study Sites (1)

Établissement Public de Santé Barthélemy Durand

Étampes, France, 91150, France

Location

Related Publications (4)

• Cromwell EA, Dube Q, Cole SR, Chirambo C, Dow AE, Heyderman RS, Van Rie A. Validity of US norms for the Bayley Scales of Infant Development-III in Malawian children. Eur J Paediatr Neurol. 2014 Mar;18(2):223-30. doi: 10.1016/j.ejpn.2013.11.011. Epub 2013 Dec 31.

  PMID: 24423629 BACKGROUND

• Rabain-Jamin J, Wornham WL. [Changes in maternal behavior and care practices in migrant women from Western Africa]. Psychiatr Enfant. 1990;33(1):287-319. French.

  PMID: 2277816 BACKGROUND

• Karasik LB, Adolph KE, Tamis-Lemonda CS, Bornstein MH. WEIRD walking: cross-cultural research on motor development. Behav Brain Sci. 2010 Jun;33(2-3):95-6. doi: 10.1017/S0140525X10000117. Epub 2010 Jun 15.

  PMID: 20546664 BACKGROUND

• Aina OF, Morakinyo O. Normative data on mental and motor development in Nigerian children. West Afr J Med. 2005 Apr-Jun;24(2):151-6. doi: 10.4314/wajm.v24i2.28187.

  PMID: 16092318 BACKGROUND

Related Links

• Batista Wiese, E., Van Dijk, M., \& Seddik, H. (2009). La matrice familiale dans l'immigration : trauma et résilience. Dialogue, 67-78.
• Nguefack, S., Mbanga, V., \& Mbassi, A. (2017). Développement psychomoteur d'une population de nourrissons camerounais à Yaoundé. Afrique Pédiatre génétique médicale, 26-33.

Study Officials

• Camille Aguillon

  Établissement Public de Santé Barthélemy Durand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adelaide Aduayi

CONTACT

+33 1 75 02 16 81; adelaide.aduayi@eps-etampes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 25, 2025
• Study Start: October 6, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)