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Psychomotor PerformanceDEVMOTSUDNCT07191691

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

An observational study of Psychomotor Performance and Child Development, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 16 days to 24 months
What is being tested?
Bayley Scales of Infant and toddler Development, fourth edition (BSID-4)
How many people
240 participants
Where
1 siteFrance
Study dates
6 Oct 2025to 30 Sep 2027
How long will I take part?
1 Day
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 days to 24 months
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

  • 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

Who cannot join

  • Not Applicable

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site
  • Établissement Public de Santé Barthélemy Durand

    Étampes, France, 91150

    Adelaide Aduayi, +33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr

    Camille Aguillon

Other trials in France

About this study

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 :

Read more

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.

Read the detailed 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.

Being tested
Bayley Scales of Infant and toddler Development, fourth edition (BSID-4)
Keywords
Psychomotricity, Child Development, Culture, Migration, Bayley Scales of Infant and toddler Development

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT07191691
Study groupRoleWhat they receive
Children born in France to parents born in Sub-Saharan AfricaSubject 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.
Receives: Diagnostic Test: Bayley Scales of Infant and toddler Development, fourth edition (BSID-4)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Between 60 and 90 minutes

Secondary outcomes (1)
  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.

    Measured: Between 60 and 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2025
  2. Study start6 Oct 2025 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
240 participants (estimated)
Target duration
1 Day
IDs, dates and publications
ClinicalTrials.gov ID
NCT07191691
Sponsor's protocol ID
22P02
Other IDs
2025-A00487-42
Acronym
DEVMOTSUD
Status last verified
Sep 2025
First submitted
17 Sep 2025
Last updated
25 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 16092318

Questions about this trial

What is this clinical trial studying?

An observational study of Psychomotor Performance and Child Development, run by Etablissement Public de Santé Barthélemy Durand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adelaide Aduayi (+33 1 75 02 16 81, adelaide.aduayi@eps-etampes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Verify the existence of specific characteristics in the motor development of children born in France to parents born in Sub-Saharan Africa. (time frame: Between 60 and 90 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07191691, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.

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