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
- Conditions
- Autism Spectrum Disorder
- Interventions
- Diagnostic Test: AMSE
- Registration Number
- NCT06549179
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 410
- Patient 18 years of age or older
- Patient who has requested, on his or her own or through a relative, a diagnostic evaluation in an expert center for the diagnosis of ASD.
- Patient covered by national health insurance
- Patient with a previous ASD diagnostic evaluation
- Patient with a previous AMSE assessment
- Absence of informed consent (patient or his/her legal guardian)
- Pregnant or breast-feeding
- Patient deprived of freedom
- Non-French-speaking patient and/or parents and/or legal guardians
- AMSE not, incorrectly or inadequately completed by non-expert psychiatrist or psychologist
- Patient covered by Aide Medicale d'Etat (AME)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients evaluated by AMSE AMSE Adult patients seeking ASD diagnostic evaluation in an expert center.
- Primary Outcome Measures
Name Time Method 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. 0-12 months from AMSE rating 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).
- Secondary Outcome Measures
Name Time Method Accuracy of the AMSE tool, rated by an expert psychiatrist or psychologist, in identifying ASD in adults. 0-12 months from AMSE expert rating 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.
AMSE score according to differential diagnosis 0-12 months from AMSE rating Mean, standard deviation, median, min, max, inter quartile range of AMSE rated by a non-expert psychiatrist or psychologist trained to the tool
Exploratory : predictive model of ASD diagnosis 0-12 months from AMSE rating 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.
Other accuracy measures of the AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool, in identifying ASD in adults. 0-12 months from AMSE rating Positive and negative likelihood ratio, positive and negative predictive values for different thresholds, compared to the reference standard.
Acceptability on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool. Immediately after AMSE rating 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.
Feedback on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool. Immediately after AMSE rating 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.
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). 0-12 months from AMSE rating 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.
Differential diagnoses 0-12 months from AMSE rating Presence and nature of differential diagnosis (personality disorders, anxiety disorders, schizophrenia spectrum disorders, other neurodevelopmental disorders) made by the expert multidisciplinary team.