Autism Spectrum DisorderNCT05815095
Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services
An observational study of Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
Trial summary
This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome Read more about this study
- Who is it for?
- Ages 3 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Neurodevelopmental Disorders
- What is being tested?
- PREAUT grid
- How many people
- 10,400 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2025to 14 Apr 2032
- 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 3 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants aged at least 4 months at study inclusion and followed in Maternal and Child Protection Services
Who may be able to join
- Infants between 4 and 9 months of age followed up in the participating Maternal and Child Protection Services for the fourth and ninth-month mandatory vaccinations
- Availability of a personnel telephone for at least one parent
- Information to the parents for data collection and the active follow-up of the child until 36 months and express consent to participate in the research
- Affiliation to a social security system or benefiting from the Medical assistance of the state
- Mastery of a minimum of French according to the principal investigator or the presence of a French-speaking relative
Who cannot join
- Infant with a severe neurological pathology such as encephalopathy
- Refusal to participate in the study
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, 1 recruiting
- Recruiting
PMI Stalingrad
Champigny-sur-Marne, 94500
Catherine DELMAS, MD, 0147064925
About this study
Official title: Randomized Pragmatic, Cluster, Stepped-wedge Trial of Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services for Care Before 1 Year of Follow-up
This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome
Read the detailed description
This prospective cohort study is performed at several Maternal and Child Protection Services in France. It aims to early detect infants under 12 months of age with a developmental gap compared to that expected for their age.
The first consultation will occur at the same time as the infant's usual medical follow-up at the Maternal and Child Protection Service (usually vaccination in the fourth month and developmental examination at nine months). Two strategies will be evaluated during this visit to assess the infant's neurodevelopmental characteristics. In the first one, a health professional will assess the infant's neurodevelopmental characteristics through routine practice evaluations, such as motor skills, vocalizations, babbling, and social interactions. In the second one, the PREAUT grid will be used for screening of screening for autism spectrum disorder.
Patients with abnormal results in these evaluations would be referred to a specialized center early for advice and treatment if necessary. We will consider an early referral as the referral of infants to an adapted consultation within the month following the first consultation. Also, these patients will be assessed using the State-Trait Anxiety Inventory-Form Y and T and the QUALIN score.
After 12 months of follow-up, data regarding the received treatments of patients who were addressed to a specialized center will be performed.
At 24 and 36 months of follow-up, all the included patients will be assessed with the Modified Checklist for Autism in Toddlers, Revised with Follow-up instrument (M-CHAT-R/F) ,and the IDE ( the French version of the Child Development Inventory). In case of an abnormal result of the M-CHAT-R/F, the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) will be administered. In case of an abnormal result of the IDE, the Brunet-Lézine scale will be administered.
Finally, the French health insurance claims databases will be used to evaluate the care pathway of all included patients up to 48 months of the child.
- Being tested
- PREAUT grid
- Keywords
- Autism Spectrum Disorder / diagnosis, Neurodevelopmental Disorders /diagnosis, Infant, Prospective Study
- Medical subject headings
- Autism Spectrum Disorder, Neurodevelopmental Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PREAUT gridOther
Patient with abnormal results in this evaluation would be referred to a specialized center early for advice and treatment if necessary
| Study group | Role | What they receive |
|---|---|---|
| Routine practice (control) | In this group, a health professional will assess the infant's neurodevelopmental characteristics through routine practice evaluations, such as motor skills, vocalizations, babbling, and social interactions | |
| Use of PREAUT Grid (intervention) | In this group, a health professional will assess the infant's neurodevelopmental characteristics using the PREAUT grid Receives: Other: PREAUT grid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one
Measured: At 2 years of age
Secondary outcomes (12)
Effectiveness of two screening strategies on the occurrence severity of Autism Spectrum Disorders (ASD) and Neurodevelopmental Disorders (NDD)
Measured: At 2 and 3 years of age
Predictive performance of the PREAUT grid (at four months and nine months) compared to the usual diagnosis
Measured: At 2 and 3 years of age
Association between ASD-NDD diagnosis and neonatal or familial risk factors
Measured: At 2 and 3 years of age of child's referral to the Medical psychological center
Quality of life assessed by the QUALIN score
Measured: At inclusion in Maternal and Child Protection Services or at Medical-psychological center and at 2 and 3 years of age
Measurement of the parents' psychological state at the time of the child's referral to the Medical psychological center
Measured: At a Medical-psychological center and at 2 and 3 years of age
Impact on the family life (IOFS) of a child diagnosed with risk of Autism Spectrum and Neurodevelopmental Disorders
Measured: At 2 and 3 years of age
Evaluation of the implementation of the new model of systematic screening of infants in Maternal and Child Protection Services and systematic referral to the Medical-psychological center
Measured: Through study completion, an average of 4 years
Evaluation of the implementation of infant care in the Medical-psychological center
Measured: Through study completion, an average of 4 years
Qualitative study of the incentives and obstacles of the screening and early referral strategy with the Maternal and Child Protection Service's workers
Measured: Through study completion, an average of 4 years
Qualitative study of the screening and early referral strategy with parents
Measured: Through study completion, an average of 4 years
Description of the practice of identification by the Maternal and Child Protection Services and referral to the Medical-psychological center
Measured: At the inclusion, at the end of inclusion and at the late visit
Description of the care pathway in the two groups
Measured: At 4 years of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start14 Apr 2025
- Primary completion14 Apr 2030 (estimated)
- Study completion14 Apr 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies 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
- 10,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815095
- Sponsor's protocol ID
- PRECO TSA
- Status last verified
- Jun 2025
- First submitted
- 9 Mar 2023
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Delmas C, Wang XX, Pelloux AS, Caeymaex L, Bouaziz N, Aegerter P, Jung C. Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol). BMJ Open. 2025 Aug 4;15(8):e094729. doi: 10.1136/bmjopen-2024-094729.
PubMed 40759525
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pragmatic, Cluster, Stepped-wedge Trial of Early Detection and Referral for Autism and Neurodevelopmental Disorders at the Maternal and Child Protection Services for Care Before 1 Year of Follow-up
- ClinicalTrials.gov ID
- NCT05815095
- Acronym / sponsor ID
- PRECO TSA
- Keywords
- Autism Spectrum Disorder / diagnosis, Neurodevelopmental Disorders /diagnosis, Infant, Prospective Study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 14 Apr 2030 (estimated)
- Study completion
- 14 Apr 2032 (estimated)
- First posted
- 18 Apr 2023 (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.
This study aims to compare two screening strategies for identifying infants with a potential risk of Autism Spectrum and Neurodevelopmental Disorders to provide early access to care and increase the likelihood of a favorable outcome
Detailed description
This prospective cohort study is performed at several Maternal and Child Protection Services in France. It aims to early detect infants under 12 months of age with a developmental gap compared to that expected for their age.
The first consultation will occur at the same time as the infant's usual medical follow-up at the Maternal and Child Protection Service (usually vaccination in the fourth month and developmental examination at nine months). Two strategies will be evaluated during this visit to assess the infant's neurodevelopmental characteristics. In the first one, a health professional will assess the infant's neurodevelopmental characteristics through routine practice evaluations, such as motor skills, vocalizations, babbling, and social interactions. In the second one, the PREAUT grid will be used for screening of screening for autism spectrum disorder.
Patients with abnormal results in these evaluations would be referred to a specialized center early for advice and treatment if necessary. We will consider an early referral as the referral of infants to an adapted consultation within the month following the first consultation. Also, these patients will be assessed using the State-Trait Anxiety Inventory-Form Y and T and the QUALIN score.
After 12 months of follow-up, data regarding the received treatments of patients who were addressed to a specialized center will be performed.
At 24 and 36 months of follow-up, all the included patients will be assessed with the Modified Checklist for Autism in Toddlers, Revised with Follow-up instrument (M-CHAT-R/F) ,and the IDE ( the French version of the Child Development Inventory). In case of an abnormal result of the M-CHAT-R/F, the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule (ADOS) will be administered. In case of an abnormal result of the IDE, the Brunet-Lézine scale will be administered.
Finally, the French health insurance claims databases will be used to evaluate the care pathway of all included patients up to 48 months of the child.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine practice (control) | – | –In this group, a health professional will assess the infant's neurodevelopmental characteristics through routine practice evaluations, such as motor skills, vocalizations, babbling, and social interactions |
| Use of PREAUT Grid (intervention) | – | Other: PREAUT gridIn this group, a health professional will assess the infant's neurodevelopmental characteristics using the PREAUT grid |
Who may qualify
- Ages
- 3 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants aged at least 4 months at study inclusion and followed in Maternal and Child Protection Services
Key inclusion criteria (5 listed)
- Infants between 4 and 9 months of age followed up in the participating Maternal and Child Protection Services for the fourth and ninth-month mandatory vaccinations
- Availability of a personnel telephone for at least one parent
- Information to the parents for data collection and the active follow-up of the child until 36 months and express consent to participate in the research
- Affiliation to a social security system or benefiting from the Medical assistance of the state
- Mastery of a minimum of French according to the principal investigator or the presence of a French-speaking relative
Key exclusion criteria (2 listed)
- Infant with a severe neurological pathology such as encephalopathy
- Refusal to participate in the study
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 |
|---|---|---|
| PREAUT gridPatient with abnormal results in this evaluation would be referred to a specialized center early for advice and treatment if necessary | Other | Use of PREAUT Grid (intervention) |
Primary outcome
Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one
Time frame: At 2 years of age
12 secondary outcomes
Effectiveness of two screening strategies on the occurrence severity of Autism Spectrum Disorders (ASD) and Neurodevelopmental Disorders (NDD)
Time frame: At 2 and 3 years of age
Predictive performance of the PREAUT grid (at four months and nine months) compared to the usual diagnosis
Time frame: At 2 and 3 years of age
Association between ASD-NDD diagnosis and neonatal or familial risk factors
Time frame: At 2 and 3 years of age of child's referral to the Medical psychological center
Quality of life assessed by the QUALIN score
Time frame: At inclusion in Maternal and Child Protection Services or at Medical-psychological center and at 2 and 3 years of age
Measurement of the parents' psychological state at the time of the child's referral to the Medical psychological center
Time frame: At a Medical-psychological center and at 2 and 3 years of age
Impact on the family life (IOFS) of a child diagnosed with risk of Autism Spectrum and Neurodevelopmental Disorders
Time frame: At 2 and 3 years of age
Evaluation of the implementation of the new model of systematic screening of infants in Maternal and Child Protection Services and systematic referral to the Medical-psychological center
Time frame: Through study completion, an average of 4 years
Evaluation of the implementation of infant care in the Medical-psychological center
Time frame: Through study completion, an average of 4 years
Qualitative study of the incentives and obstacles of the screening and early referral strategy with the Maternal and Child Protection Service's workers
Time frame: Through study completion, an average of 4 years
Qualitative study of the screening and early referral strategy with parents
Time frame: Through study completion, an average of 4 years
Description of the practice of identification by the Maternal and Child Protection Services and referral to the Medical-psychological center
Time frame: At the inclusion, at the end of inclusion and at the late visit
Description of the care pathway in the two groups
Time frame: At 4 years of the child
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 13 Jun 2025.
- Derived from this study: PubMed 40759525Delmas C, Wang XX, Pelloux AS, Caeymaex L, Bouaziz N, Aegerter P, Jung C. Effectiveness of early detection and coordinated referral of infants before 1 year at risk for autism spectrum and neurodevelopmental disorders in maternal and child protection centre: a French randomised pragmatic trial in a stepped-wedge trial (PRECO-TSA protocol). BMJ Open. 2025 Aug 4;15(8):e094729. doi: 10.1136/bmjopen-2024-094729.
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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.
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 Autism Spectrum Disorder and Neurodevelopmental Disorders, run by Centre Hospitalier Intercommunal Creteil 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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 Jun 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 Catherine DELMAS, MD (01 47 06 49 25, catherine.delmas@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one (time frame: At 2 years of age). 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 NCT05815095, which also lists 1 linked publication.
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 13 Jun 2025.