Clinical trial NCT06549179: 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
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Autism Spectrum Disorder
Keywords: Autism Mental Status Disorder
Adult
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 410
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults (aged 18 or over) requesting a diagnostic assessment in an expert center.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: 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.
timeFrame: 0-12 months from AMSE rating
Secondary outcomes:
measure: Other accuracy measures of the AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool, in identifying ASD in adults.
timeFrame: 0-12 months from AMSE rating
measure: 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).
timeFrame: 0-12 months from AMSE rating
measure: Accuracy of the AMSE tool, rated by an expert psychiatrist or psychologist, in identifying ASD in adults.
timeFrame: 0-12 months from AMSE expert rating
measure: Differential diagnoses
timeFrame: 0-12 months from AMSE rating
measure: AMSE score according to differential diagnosis
timeFrame: 0-12 months from AMSE rating
measure: Acceptability on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool.
timeFrame: Immediately after AMSE rating
measure: Feedback on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool.
timeFrame: Immediately after AMSE rating
measure: Exploratory : predictive model of ASD diagnosis
timeFrame: 0-12 months from AMSE rating
measure: Exploratory : predictive model of ASD diagnosis
timeFrame: 0-12 months from AMSE rating
Other outcomes:
Locations:
Study officials:
References: