Early Screening of Autism Spectrum Disorder in General and Pediatric Practices (KitCAT)
Primary Purpose
Autism Spectrum Disorder
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC)
Sponsored by
About this trial
This is an interventional diagnostic trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, screening, ITC, M-CHAT-R
Eligibility Criteria
Inclusion Criteria:
- Patients aged between 16 and 24 months
Exclusion Criteria:
- Patient with previous Autism spectrum disorder (ASD) diagnostic
Sites / Locations
- Centre Hospitalier Le VinatierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
children aged 16 to 24
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04274127
Brief Title
Early Screening of Autism Spectrum Disorder in General and Pediatric Practices
Acronym
KitCAT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2018 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
Autism Spectrum Disorder, screening, ITC, M-CHAT-R
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
1700 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
children aged 16 to 24
Arm Type
Other
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC)
Other Intervention Name(s)
phone call by a neuropsychologist
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of children with a confirmed ASD diagnosis
Description
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
Time Frame
V4 (age of 3)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients aged between 16 and 24 months
Exclusion Criteria:
Patient with previous Autism spectrum disorder (ASD) diagnostic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Marignier
Phone
+33 4 37 91 54 65
Email
cra@ch-le-vinatier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique VIAL
Phone
+ 33 4 37 91 55 31
Email
veronique.vial@ch-le-vinatier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie Marignier
Organizational Affiliation
CH Le Vinatier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
State/Province
Rhône
ZIP/Postal Code
69678
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Marignier
Phone
+33 4 37 91 54 65
Email
cra@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Early Screening of Autism Spectrum Disorder in General and Pediatric Practices
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