Smartphone assessments for diagnosing autism
Smartphone-Based Neurobehavioral Assessments as a Diagnostic Aid in Autism
This study is testing a smartphone app that checks for signs of autism in children to see if it can accurately match up with traditional diagnoses.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 450 (estimated) |
| Ages | 3 Years to 12 Years |
| Sex | All |
| Sponsor | Blinklab Limited Industry-sponsored |
| Locations | 1 site (Salé) |
| Trial ID | NCT06497218 on ClinicalTrials.gov |
What this trial studies
This study evaluates the diagnostic accuracy of a smartphone-based platform designed to conduct neurobehavioral assessments for Autism Spectrum Disorder (ASD). It is a retrospective multi-centre case-control study that compares the results of smartphone assessments with formal clinical diagnoses. The assessments involve measuring facial and behavioral reflexes through various neurometric tests while children watch an audio-normalized movie. The study aims to utilize machine learning algorithms to analyze the data collected from children diagnosed with ASD and neurotypical children.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 to 12 years with a formal diagnosis of Autism Spectrum Disorder or neurotypical children without psychiatric diagnoses.
Not a fit: Patients outside the age range of 3 to 12 years or those with severe hearing or visual impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more accessible and accurate method for diagnosing autism in children.
How similar studies have performed: While similar approaches using technology for diagnostic purposes have shown promise, this specific method is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female individuals between the ages of 3 - 12 years old at the time of consent. * Caregiver must be able to read, understand and sign the Informed Consent Form (ICF). * Normal or corrected-to-normal vision with visual acuity sufficient to watch short videos. * Hearing adequate to hear the auditory stimuli delivered via headphones. Exclusion Criteria: * Participants under 3 or over 12 years old. * Severe hearing or visual impairment. * Participants using medication that affects the nervous system (classified as ATC N0 medication, https://www.whocc.no).
Where this trial is running
Salé
- Mohammed VI National Center for the Disabled — Salé, Morocco (Recruiting)
Study contacts
- Study coordinator: Henk-Jan Boele, MD
- Email: henkjan@blinklab.org
- Phone: +31611132247
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.