Établissement Public de Santé Barthélemy Durand
Étampes, France, 91150
Location contact
Adelaide Aduayi
CONTACT
Camille Aguillon
PRINCIPAL_INVESTIGATOR
Carole Veinberg
PRINCIPAL_INVESTIGATOR
Elisabeth Dieu
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07191691
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.
Trial opening soon.
Get Notified16 day–24 month
All sexes
Observational
Étampes, France, 91150
Adelaide Aduayi
CONTACT
Camille Aguillon
PRINCIPAL_INVESTIGATOR
Carole Veinberg
PRINCIPAL_INVESTIGATOR
Elisabeth Dieu
PRINCIPAL_INVESTIGATOR
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
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The BSID-4 is a test that evaluates three areas of child's development, divided into three scales:
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.
Time frame: Between 60 and 90 minutes
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
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.
Contact information is provided by the study sponsor or research team.
Etablissement Public de Santé Barthélemy Durand
Other
Acronym: DEVMOTSUD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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