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.
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
- Conditions the study is for
- Psychomotor Performance, Child Development, Culture
- 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
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.
- Conditions
- Psychomotor Performance, Child Development, Culture
- 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 group | Role | What they receive |
|---|---|---|
| Children born in France to parents born in Sub-Saharan Africa | Subject 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.
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)
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.
- First posted25 Sep 2025
- Study start6 Oct 2025 (estimated)
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Psychomotor PerformanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Etablissement Public de Santé Barthélemy Durand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille Aguillon, Principal investigator, Établissement Public de Santé Barthélemy Durand
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 24423629Rabain-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 2277816Karasik 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 20546664Aina 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Psychomotor Development in Children Born in France to Parents Born in Sub-Saharan Africa.
- ClinicalTrials.gov ID
- NCT07191691
- Acronym / sponsor ID
- DEVMOTSUD / 22P02
- Conditions
- Psychomotor Performance, Child Development, Culture
- Keywords
- Psychomotricity, Child Development, Culture, Migration, Bayley Scales of Infant and toddler Development
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Etablissement Public de Santé Barthélemy DurandUniversity, hospital or other
- Study start
- 6 Oct 2025 (estimated)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children born in France to parents born in Sub-Saharan Africa | – | Diagnostic Test: Bayley Scales of Infant and toddler Development, fourth edition (BSID-4)Subject 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. |
Who may qualify
- Ages
- 16 days to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children subjects from 16 days to 24 months, born in France to parents born in Sub-Saharan Africa
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Not Applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 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. | Diagnostic test | Children born in France to parents born in Sub-Saharan Africa |
Primary outcome
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
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.
1 secondary outcome
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.
Time frame: Between 60 and 90 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Background: PubMed 24423629Cromwell 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.
- Background: PubMed 2277816Rabain-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.
- Background: PubMed 20546664Karasik 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.
- Background: PubMed 16092318Aina 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.
- Batista Wiese, E., Van Dijk, M., \& Seddik, H. (2009). La matrice familiale dans l'immigration : trauma et résilience. Dialogue, 67-78.Link provided by the sponsor.
- Nguefack, S., Mbanga, V., \& Mbassi, A. (2017). Développement psychomoteur d'une population de nourrissons camerounais à Yaoundé. Afrique Pédiatre génétique médicale, 26-33.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Camille Aguillon principal investigator
Établissement Public de Santé Barthélemy Durand
1 site in 1 country: see every site and its status.
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.