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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-24
SponsorEtablissement Public de Santé Barthélemy Durand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Not Applicable

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: Children born in France to parents born in Sub-Saharan Africa1 intervention

Trial outcomes

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.

Time frame
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.

The development timeline for psychomotor skills in children born in France to parents born in Sub-Saharan Africa will be determined by calculating the average age of acquisition in the study's population for : Head control ; Grasps a presented object ; Social smile ; Reacts when spoken to ; Babbling ; Sitting unsupported ; Pulls to stand ; Moves independently (crawling, creeping, or other forms of movement) ; Imitation ; Independent walking ; Object permanence ; Thumb-index finger pincer grasp ; Turns head when name is called ; Reaction to the word "no" ; First word ; Joint attention ; Symbolic gestures ; Stacking blocks ; Points to a named object ; First phrases ; Proto-imperative pointing ; Running ; Kicking a ball.

Time frame
Between 60 and 90 minutes

Other outcomes

Sponsors and contacts

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