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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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.

Первичные конечные точки

• 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. [Срок оценки: 0-12 months from AMSE rating]

Вторичные конечные точки (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. [Срок оценки: 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). [Срок оценки: 0-12 months from AMSE rating]
• Accuracy of the AMSE tool, rated by an expert psychiatrist or psychologist, in identifying ASD in adults. [Срок оценки: 0-12 months from AMSE expert rating]
• Differential diagnoses [Срок оценки: 0-12 months from AMSE rating]
• AMSE score according to differential diagnosis [Срок оценки: 0-12 months from AMSE rating]
• Acceptability on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool. [Срок оценки: Immediately after AMSE rating]
• Feedback on the AMSE tool by non-expert psychiatrists or psychologists trained to use the tool. [Срок оценки: Immediately after AMSE rating]
• Exploratory : predictive model of ASD diagnosis [Срок оценки: 0-12 months from AMSE rating]
• Exploratory : predictive model of ASD diagnosis [Срок оценки: 0-12 months from AMSE rating]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• Pitié-Salpêtrière Hospital — Paris

Идентификаторы

NCT: NCT06549179 · APHP210995

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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