Ireland
--:--IST
Recruiting Observational

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

NCT06549179 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-11-04
Last updated
2025-09-25

Condition(s) studied

Autism Spectrum Disorder

Investigational drug(s) / intervention(s)

AMSE

AMSE: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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)

Primary outcome measure(s)

  • 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 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).

Trial sites (1)

FacilityCityRegionStatus
Pitié-Salpêtrière Hospital Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06549179 on ClinicalTrials.gov ↗ ← All trials in France