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NCT Number: 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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

    Time frame: 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).

Secondary outcomes

  1. Other accuracy measures of the AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool, in identifying ASD in adults.

    Time frame: 0-12 months from AMSE rating

    Positive and negative likelihood ratio, positive and negative predictive values for different thresholds, compared to the reference standard.

  2. 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).

    Time frame: 0-12 months from AMSE rating

    Diagnostic 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.

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

    Time frame: 0-12 months from AMSE expert rating

    Diagnostic 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.

  4. Differential diagnoses

    Time frame: 0-12 months from AMSE rating

    Presence and nature of differential diagnosis (personality disorders, anxiety disorders, schizophrenia spectrum disorders, other neurodevelopmental disorders) made by the expert multidisciplinary team.

  5. AMSE score according to differential diagnosis

    Time frame: 0-12 months from AMSE rating

    Mean, standard deviation, median, min, max, inter quartile range of AMSE rated by a non-expert psychiatrist or psychologist trained to the tool

  6. Acceptability on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool.

    Time frame: Immediately after AMSE rating

    Perception 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.

  7. Feedback on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool.

    Time frame: Immediately after AMSE rating

    Perception 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.

  8. Exploratory : predictive model of ASD diagnosis

    Time frame: 0-12 months from AMSE rating

    Predictive model of ASD diagnosis for patient with intellectual disability, with AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool.

  9. Exploratory : predictive model of ASD diagnosis

    Time frame: 0-12 months from AMSE rating

    Predictive model of ASD diagnosis for patient without intellectual disability, with AMSE tool rated by a non-expert psychiatrist or psychologist trained to the tool.

Study contacts

Contact information is provided by the study sponsor or research team.

Hélène VULSER, MD-PhD

CONTACT

[email protected]

01 42 16 18 25

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: AUTI-SCREEN

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2024
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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