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
| NCT ID | NCT06549179 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Autism Spectrum Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 410 participants |
| Start Date | 2024-11-04 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 410 participants in total. It began in 2024-11-04 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06549179 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06549179 currently recruiting?
Yes, NCT06549179 is actively recruiting participants. Contact the research team at helene.vulser@aphp.fr for enrollment information.
Where is the NCT06549179 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT06549179 clinical trial?
NCT06549179 is sponsored by Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 410 participants.