NCT05815095

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,400

participants targeted

Target at P75+ for all trials

Timeline
72mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress15%
Apr 2025Apr 2032

First Submitted

Initial submission to the registry

March 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
2 years until next milestone

Study Start

First participant enrolled

April 14, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2032

Last Updated

June 13, 2025

Status Verified

June 1, 2025

Enrollment Period

5 years

First QC Date

March 9, 2023

Last Update Submit

June 11, 2025

Conditions

Autism Spectrum DisorderNeurodevelopmental Disorders

Keywords

Autism Spectrum Disorder / diagnosisNeurodevelopmental Disorders /diagnosisInfantProspective Study

Outcome Measures

Primary Outcomes (1)

  • Proportion of children at 24 months with an Autism Spectrum Disorder or Neurodevelopmental Disorder diagnosis who received care before the age of one

    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)

    At 2 and 3 years of age

  • Predictive performance of the PREAUT grid (at four months and nine months) compared to the usual diagnosis

    At 2 and 3 years of age

  • Association between ASD-NDD diagnosis and neonatal or familial risk factors

    At 2 and 3 years of age of child's referral to the Medical psychological center

  • Quality of life assessed by the QUALIN score

    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

    At a Medical-psychological center and at 2 and 3 years of age

  • +7 more secondary outcomes

Study Arms (2)

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

Other: PREAUT grid

Interventions

PREAUT gridOTHER

Patient with abnormal results in this evaluation would be referred to a specialized center early for advice and treatment if necessary

Use of PREAUT Grid (intervention)

Eligibility Criteria

Age3 Months - 12 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants aged at least 4 months at study inclusion and followed in Maternal and Child Protection Services

You may qualify if:

  • 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

You may not qualify if:

  • Infant with a severe neurological pathology such as encephalopathy
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PMI Stalingrad

Champigny-sur-Marne, 94500, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40759525DERIVED

MeSH Terms

Conditions

Autism Spectrum DisorderNeurodevelopmental DisordersDisease

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Catherine DELMAS, MD

CONTACT

01 47 06 49 25catherine.delmas@chicreteil.fr

Camille JUNG, MD

CONTACT

01 57 02 22 68camille.jung@chicreteil.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2023

First Posted

April 18, 2023

Study Start

April 14, 2025

Primary Completion (Estimated)

April 14, 2030

Study Completion (Estimated)

April 14, 2032

Last Updated

June 13, 2025

Record last verified: 2025-06

Locations

FR(1)