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
NCT Number: NCT06549179
Acronym: AUTI-SCREEN
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Autism Spectrum Disorder
Interventions: DIAGNOSTIC_TEST: AMSE
Sponsor: Assistance Publique - Hôpitaux de Paris
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 410
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-09-15
Completion Date: 2027-08-01

Summary:
To improve diagnosis of Autism Spectrum Disorder (ASD), expert centers have been set up in France since 2000/2010. 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 (0.91) and specificity (0.93). 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.

Primary Outcome Measures: Accuracy of the AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool, and considered here as the index test, in identifying ASD in adults., Diagnostic performance as measured by sensitivity, specificity, area under the receiver operating characteristic curve for different thresholds, compared to the reference standard.

The reference standard is the final diagnosis made by the expert multidisciplinary team according to DSM-5 criteria for ASD, based on all routine assessments, i.e.: anamnesis and use of standardized tools with, at best, Autism Diagnostic Observation Scale (ADOS-2) (if fluid language) and Autism Diagnostic Interview (ADI-R) (if accompanying parent present), or, alternatively : Adult Asperger Assessment (AAA), (ASD-DA), Echelle des Comportements Répétés et Restreints (EC2R), Pervasive Developmental Disorder in Mental Retardation Scale (PDD-MRS)., 0-12 months from AMSE rating
Secondary Outcome Measures: Other accuracy measures of the AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool, in identifying ASD in adults., Positive and negative likelihood ratio, positive and negative predictive values for different thresholds, compared to the reference standard., 0-12 months from AMSE rating|Accuracy of the AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool, in identifying ASD in adults, according to the presence or absence of an intellectual disability (Intellectual coefficient<70 measured on the WAIS-IV)., Diagnostic performance as measured by sensitivity, specificity, positive and negative likelihood ratio, positive and negative predictive values, area under the receiver operating characteristic curve for different thresholds, compared to the reference standard., 0-12 months from AMSE rating|Accuracy of the AMSE tool, rated by an expert psychiatrist or psychologist, in identifying ASD in adults., Diagnostic performance as measured by sensitivity, specificity, positive and negative likelihood ratio, positive and negative predictive values, area under the receiver operating characteristic curve for different thresholds, compared to the reference standard., 0-12 months from AMSE expert rating|Differential diagnoses, Presence and nature of differential diagnosis (personality disorders, anxiety disorders, schizophrenia spectrum disorders, other neurodevelopmental disorders) made by the expert multidisciplinary team., 0-12 months from AMSE rating|AMSE score according to differential diagnosis, Mean, standard deviation, median, min, max, inter quartile range of AMSE rated by a non-expert psychiatrist or psychologist trained to the tool, 0-12 months from AMSE rating|Acceptability on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool., Perception of the tool's relevance, ease of completion, completion time (duration in minutes), use of written guide, use of self-training video tutorial, and previous experience with the tool., Immediately after AMSE rating|Feedback on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool., Perception of the tool's relevance, ease of completion, completion time (duration in minutes), use of written guide, use of self-training video tutorial, and previous experience with the tool., Immediately after AMSE rating|Exploratory : predictive model of ASD diagnosis, Predictive model of ASD diagnosis for patient with intellectual disability, with AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool., 0-12 months from AMSE rating|Exploratory : predictive model of ASD diagnosis, Predictive model of ASD diagnosis for patient without intellectual disability, with AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool., 0-12 months from AMSE rating