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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-10-06

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Context From the 1950s to the 1970s, studies conducted in Sub-Saharan Africa showed that children acquired independent walking skills at an earlier age. Anthropological research carried out between 1970 and 2000 highlighted differences in mothering practices, shaped by the cultural and environmental context in which children and their parents live.

Since the 2000s, research on child development in Sub-Saharan Africa has increasingly focused on the timing of motor development. The frequency and nature of caregiving practices have been shown to influence the early acquisition of certain skills, while contributing to delays or absence of others. It has therefore been established that the timing and sequence of motor milestones differ between children raised in Sub-Saharan Africa and those raised in France.

In contrast, no data currently exist on the development of children of Sub-Saharan African origin raised in France. Migration-often accompanied by the loss of familiar social and cultural frameworks-is recognized as a significant vulnerability factor. Studies have shown that migration leads to changes in both the frequency and style of caregiving practices.

To date, to the investigators' knowledge, there are no scientific data on the developmental timeline of children born in France to parents from Sub-Saharan Africa (referred to as PNA subjects). However, empirical observations by psychomotor therapists working with PNA children suggest the persistence of certain developmental specificities. One of the most commonly reported signs by parents is early independent walking.

Objectives The primary objective is to determine whether there are specific characteristics of psychomotor development in children born in France to parents born in Sub-Saharan Africa The secondary objective is to establish a timetable of psychomotor development in children born in France to parents born in Sub-Saharan Africa for twenty three items from the developmental early screening standards provided by the government to early childhood professionals.

Hypothesis 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?

Methods This study is prospective, comparative, multicenter, non-randomized observational, cohort study

The only visit for included subjects will proceed as follows:

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. The total duration of the single study visit is estimated to be between 60 and 90 minutes.

Inclusion criteria

* Children born in France aged 16 days to 24 months at the time of inclusion;
* Both parents born in a homogeneous geographical area: Sub-Saharan African countries;
* Children with no known pathology;
* Birth from 37 SA and before 42 SA;
* Birth weight greater than or equal to 2kg500 ;
* Apgar score at 10 to 5 minutes after birth;
* No opposition to data collection from holders of parental authority.

Non-inclusion criteria Not applicable

Study location Barthélemy Durand Hospital at Etampes, France

Results and Outcome Confirmation of the existence of specific psychomotor development characteristics in children born in France to parents born in Sub-Saharan Africa.

Conditions

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Psychomotor Performance Child Development Culture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Children born in France, aged 16 days to 24 months at the time of inclusion
* 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