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NCT06549179Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 25 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
410 (estimated)
First submitted
14 Feb 2024
Start date
4 Nov 2024
Primary completion date
1 Nov 2027
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Diseases
Autism
NCT number
NCT06549179

What you commit to

  • Study type: Observational
  • Planned participants: 410
  • From 4 Nov 2024 to the primary completion date, 1 Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient who has previously undergone a diagnostic assessment resulting in a diagnosis of Autism Spectrum Disorder (ASD) made by a psychiatrist or child psychiatrist

Other

  • 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)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Pitié Salpêtrière Hospital
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ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.