Early Screening of Autism Spectrum Disorder in General and Pediatric Practices

NCT04274127 | Completed

• 1 other identifier: 2015-A00823-46
• Study Type: interventional
• Target: 1,211
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; screening; ITC; M-CHAT-R

Outcome Measures

Primary Outcomes (1)

• number of children with a confirmed ASD diagnosis

  number of children with a confirmed ASD diagnosis who had an M-CHAT-R and/or CSBS- ITC score confirmed positive at phone call by the neuropsychologist

  V4 (age of 3)

Study Arms (1)

children aged 16 to 24

OTHER

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.

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

Interventions

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

Also known as: phone call by a neuropsychologist

children aged 16 to 24

Eligibility Criteria

• Age: 16 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged between 16 and 24 months

You may not qualify if:

• Patient with previous Autism spectrum disorder (ASD) diagnostic

Sponsors & Collaborators

• Hôpital le Vinatier: lead

Study Sites (1)

Centre Hospitalier Le Vinatier

Bron, Rhône, 69678, France

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Stéphanie Marignier

  CH Le Vinatier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: April 9, 2018
• Primary Completion: December 4, 2024
• Study Completion: December 31, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)