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临床试验/NCT07191691
NCT07191691尚未招募不适用

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

Etablissement Public de Santé Barthélemy Durand1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2025年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
240
试验地点
1
主要终点
Verify the existence of specific characteristics in the motor development of children born in France to parents born in Sub-Saharan Africa.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Days 至 24 Months(Child)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Not Applicable

结局指标

主要结局

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

时间窗: 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.

次要结局

  • 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)

研究者

发起方
Etablissement Public de Santé Barthélemy Durand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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