Early Screening of Autism Spectrum Disorder in General and Pediatric Practices (KitCAT)

Early Screening of Autism Spectrum Disorder in General and Pediatric Practices, Nurseries and Early Child Care Centers, Using Parent Questionnaires and Guidance for Addressing the Child

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Diagnostic test: early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC)

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.

• Study Type: Interventional
• Enrollment (Actual): 1211
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône
    • Bron, Rhône, France, 69678
      • Centre Hospitalier le Vinatier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 2 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged between 16 and 24 months

Exclusion Criteria:

• Patient with previous Autism spectrum disorder (ASD) diagnostic

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

Diagnostic test: 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.; Other Names: phone call by a neuropsychologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Hôpital le Vinatier
• Investigators: Principal Investigator: Stéphanie Marignier, CH Le Vinatier

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2018
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 14, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: screening; Autism Spectrum Disorder; ITC; M-CHAT-R
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autism Spectrum Disorder; Autistic Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 2015-A00823-46

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No