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

Etablissement Public de Santé Barthélemy Durand

Status: Not yet enrolling

Conditions: Culture; Child Development; Psychomotor Performance

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

Study type: Observational

Funder types: Other

Identifiers

NCT07191691

2025-A00487-42 (Registry Identifier)

22P02

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 16 days to 24 months old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• Not Applicable

Trial design

240 participants in 1 patient group

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

Description:

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.

Treatment:

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