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

NCT ID: NCT06549179

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 410 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-04
• Study Completion Date: 2027-11-01

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.

Conditions

Autism Spectrum Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients evaluated by AMSE

Adult patients seeking ASD diagnostic evaluation in an expert center.

AMSE

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pitié-Salpêtrière Hospital

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Hélène VULSER, MD-PhD

Role: CONTACT

helene.vulser@aphp.fr

01 42 16 18 25

Facility Contacts

Hélène VULSER, MD

Role: primary

helene.vulser@aphp.fr

01 42 16 18 25

Other Identifiers

APHP210995

Identifier Type: -

Identifier Source: org_study_id