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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 (AUTI-SCREEN)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Autism Spectrum Disorder

Treatments

Diagnostic Test: AMSE

Study type

Observational

Funder types

Other

Identifiers

NCT06549179
APHP210995

Details and patient eligibility

About

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.

Full 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.

Enrollment

410 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

410 participants in 1 patient group

Patients evaluated by AMSE
Description:
Adult patients seeking ASD diagnostic evaluation in an expert center.
Treatment:
Diagnostic Test: AMSE

Trial contacts and locations

1

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Central trial contact

Hélène VULSER, MD-PhD

Data sourced from clinicaltrials.gov

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