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 | Recruiting

• 1 other identifier: APHP210995
• Study Type: observational
• Target: 410
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Mental Status Disorder; Adult

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (9)

• 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

• 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

• Accuracy of the AMSE tool, rated by an expert psychiatrist or psychologist, in identifying ASD in adults.

  0-12 months from AMSE expert rating

• Differential diagnoses

  0-12 months from AMSE rating

• AMSE score according to differential diagnosis

  0-12 months from AMSE rating

Study Arms (1)

Patients evaluated by AMSE

Adult patients seeking ASD diagnostic evaluation in an expert center.

Diagnostic Test: AMSE

Interventions

AMSE DIAGNOSTIC_TEST

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.

Patients evaluated by AMSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults (aged 18 or over) requesting a diagnostic assessment in an expert center.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Pitié-Salpêtrière Hospital

Paris, France

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Hélène VULSER, MD-PhD

CONTACT

01 42 16 18 25; helene.vulser@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: August 12, 2024
• Study Start: November 4, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

FR (1)