Early Screening of Autism Spectrum Disorder in General and Pediatric Practices

NCT ID: NCT04274127

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-09
• Study Completion Date: 2024-12-31

Brief Summary

Early screening for Autism Spectrum Disorder has been validated using different screening tools, in particular M-CHAT-R and ITC in different countries. Unfortunaltely, in France, they are not often used. Thus, medium age for diagnosis in France is late. Yet, early interventions has shown efficiency (grade B of HAS 2010 recommendations, HAS 2018) . The American have described an efficient method using partnership between pediatricians and autism specialists (Miller et al). Autism Spectrum Disorders concern 1% of population. The third Autism Plan in France then HAS 2018 Recommandations and The 2018 National Strategy for Autism have propose to implement three levels for early diagnostic : the frontline is constituted by professionals who can detect the firsts signs ( in nurseries, general practice, pediatric practice, early childhood centers), the second line is constituted by the proximity network of professionals who can diagnose " simple " autism ( CMP, CAMSP, neurologic pediatricians), the third line is constituted by expert teem in specialized hospital centers for neurodevelopmental disorders diagnostic.

This organization is, for now, not efficient. First lines professionals are not always formed to autism detection. When the screening is efficient, professionals have difficulties to address children to proximity teem trained to autism diagnostic because of delays or lack of professionals. The second line professionals are note always trained to use diagnostic tools and tend to address all the children to the third line, even when the diagnostic is not complex. The third lign is saturated by all these requests.

Detailed Description

The investigator propose to improve autism screening in our region of Rhône-Alpes basing on the detection in nursery, and by first line doctors in order to diagnose autism before 3 year of age. After screening, a specialized teem will realize a follow-up by phone to guide practitioners to a diagnostic teem in proximity. Early screening realized near family house is compulsory to facilitate accessibility and collaboration between professionals. Diagnostic should be realized in a three month delay, conform to the recommendations. Our project proposes to screen the general population of children who hasn't been screened yet for autism.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

children aged 16 to 24

estimate the positive predictive value of an early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC) followed by a confirmation of the detection with a phone call by a neuropsychologist, in children aged 16 to 24 months seen by their usual general practitioner or pediatrician or child care centers or attending nurseries.

Group Type: OTHER

early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC)

Intervention Type: DIAGNOSTIC_TEST

completion of 2 questionnaires (M-CHAT-R + CSBS-ITC) followed by a confirmation of the detection with a phone call by a neuropsychologist, in children aged 16 to 24 months seen by their usual general practitioner or pediatrician or child care centers or attending nurseries.

Interventions

early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC)

completion of 2 questionnaires (M-CHAT-R + CSBS-ITC) followed by a confirmation of the detection with a phone call by a neuropsychologist, in children aged 16 to 24 months seen by their usual general practitioner or pediatrician or child care centers or attending nurseries.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

phone call by a neuropsychologist

Eligibility Criteria

Inclusion Criteria

• Patients aged between 16 and 24 months

Exclusion Criteria

• Patient with previous Autism spectrum disorder (ASD) diagnostic

• Minimum Eligible Age: 16 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hôpital le Vinatier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stéphanie Marignier

Role: PRINCIPAL_INVESTIGATOR

CH Le Vinatier

Locations

Centre Hospitalier Le Vinatier

Bron, Rhône, France

Countries

France

Other Identifiers

2015-A00823-46

Identifier Type: -

Identifier Source: org_study_id