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Набор скоро начнётся NCT07191691

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

Наблюдательное Psychomotor Performance Child Development Culture

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Bayley Scales of Infant and toddler Development, fourth edition (BSID-4).
Кому может быть актуально
Состояния в реестре: Psychomotor Performance, Child Development, Culture. Базовые параметры: 16 Days — 24 мес. · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Подробное описание

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.

Вмешательства

  • Диагностический тест 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 subte

Первичные конечные точки

  • Verify the existence of specific characteristics in the motor development of children born in France to parents born in Sub-Saharan Africa. [Срок оценки: Between 60 and 90 minutes]
Вторичные конечные точки (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. [Срок оценки: Between 60 and 90 minutes]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • Not Applicable

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Établissement Public de Santé Barthélemy Durand — Étampes

Публикации

  • Cromwell EA, Dube Q, Cole SR, Chirambo C, Dow AE, Heyderman RS, Van Rie A. Validity of US norms for the Bayley Scales of Infant Development-III in Malawian children. Eur J Paediatr Neurol. 2014 Mar;18(2):223-30. doi: 10.1016/j.ejpn.2013.11.011. Epub 2013 Dec 31. PMID 24423629
  • Rabain-Jamin J, Wornham WL. [Changes in maternal behavior and care practices in migrant women from Western Africa]. Psychiatr Enfant. 1990;33(1):287-319. French. PMID 2277816
  • Karasik LB, Adolph KE, Tamis-Lemonda CS, Bornstein MH. WEIRD walking: cross-cultural research on motor development. Behav Brain Sci. 2010 Jun;33(2-3):95-6. doi: 10.1017/S0140525X10000117. Epub 2010 Jun 15. PMID 20546664
  • Aina OF, Morakinyo O. Normative data on mental and motor development in Nigerian children. West Afr J Med. 2005 Apr-Jun;24(2):151-6. doi: 10.4314/wajm.v24i2.28187. PMID 16092318

Идентификаторы

NCT: NCT07191691 · 22P02 · 2025-A00487-42

Первоисточники (государственные реестры)

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