Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06549179
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-02-14
Brief Title:
Validation Study of the Performance of the French Version of the Autism Mental Status Examination Scale as a Tool for Identifying Autism Spectrum Disorder in Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Validation Study of the Screening Performance of the French Version of the Autism Mental Status Examination Scale as a Tool for Identifying Autism Spectrum Disorder in Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AUTI-SCREEN
Brief Summary:
To improve diagnosis of Autism Spectrum Disorder ASD expert centers have been set up in France since 20002010 However waiting times in these centers are long mean of 19 months for adults and more than half the people seen do not end up with an ASD even though referral by a psychiatrist is increasingly required
Therefore validated diagnostic tools for screening before referral are needed The Autism Mental Status Exam AMSE a 8-item tool which is quick and easy to use appears to have excellent sensitivity 091 and specificity 093 However this tool was only evaluated when used by experts and on a sample of 50 patients
The hypothesis of this study is that the AMSE used by non-expert psychiatrists has sufficiently good diagnostic performance minimal sensitivity and specificity of respectively 93 and 65 to be used in screening adults with suspected ASD
Therefore validated diagnostic tools for screening before referral are needed The Autism Mental Status Exam AMSE a 8-item tool which is quick and easy to use appears to have excellent sensitivity 091 and specificity 093 However this tool was only evaluated when used by experts and on a sample of 50 patients
The hypothesis of this study is that the AMSE used by non-expert psychiatrists has sufficiently good diagnostic performance minimal sensitivity and specificity of respectively 93 and 65 to be used in screening adults with suspected ASD
Detailed Description:
Patients who contact one of the expert centers participating in the study for an ASD diagnostic evaluation are first referred as in usual care to a non-expert psychiatrist or psychologist from a list of professionals provided by the center and previously trained to the AMSE to complete a pre-evaluation file For the study the AMSE and a brief AMSE-filling guide is added to the file
Seven days to 12 months after patients have a 2-day consecutive or separated by a maximum of 2 months full ASD evaluation in the expert center with a final diagnosis made by the expert multidisciplinary team according to Diagnostic and Statistical Manual DSM-5 criteria for ASD
Seven days to 12 months after patients have a 2-day consecutive or separated by a maximum of 2 months full ASD evaluation in the expert center with a final diagnosis made by the expert multidisciplinary team according to Diagnostic and Statistical Manual DSM-5 criteria for ASD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None