Skip to content

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

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
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06549179
Acronym
AUTI-SCREEN
Enrollment
410
Registered
2024-08-12
Start date
2024-11-04
Completion date
2027-11-01
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

Autism Mental Status Disorder, Adult

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.

Interventions

DIAGNOSTIC_TESTAMSE

Evaluation of the performance of the French-language AMSE tool used by non-expert psychiatrists and psychologists, trained in the tool, in the identification of ASD in adults.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient 18 years of age or older * Patient who has requested, either personally, through a relative, or through a healthcare professional, a diagnostic evaluation at a center specializing in ASD diagnosis. * Patient covered by national health insurance

Exclusion criteria

* Patient who has previously undergone a diagnostic assessment resulting in a diagnosis of Autism Spectrum Disorder (ASD) made by a psychiatrist or child psychiatrist * 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)

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of the AMSE tool rated by a non-expert psychiatrist or psychologist but trained to in ASD diagnosis and to the tool, and considered here as the index test, in identifying ASD in adults.0-12 months from AMSE ratingDiagnostic 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

MeasureTime frameDescription
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 ratingDiagnostic 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.
Accuracy of the AMSE tool, rated by an expert psychiatrist or psychologist, in identifying ASD in adults.0-12 months from AMSE expert ratingDiagnostic 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 diagnoses0-12 months from AMSE ratingPresence and nature of differential diagnosis (personality disorders, anxiety disorders, schizophrenia spectrum disorders, other neurodevelopmental disorders) made by the expert multidisciplinary team.
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 ratingPositive 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 ratingPerception 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 ratingPerception 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.
Exploratory : predictive model of ASD diagnosis0-12 months from AMSE ratingPredictive model of ASD diagnosis for patient with intellectual disability, with AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool.
AMSE score according to differential diagnosis0-12 months from AMSE ratingMean, standard deviation, median, min, max, inter quartile range of AMSE rated by a non-expert psychiatrist or psychologist trained to the tool

Countries

France

Contacts

Primary ContactHélène VULSER, MD-PhD
helene.vulser@aphp.fr01 42 16 18 25

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026