Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
Sponsor: Blinklab Limited
Trial Details
| Condition | Autism, Autism Spectrum Disorder, Autism Spectrum Disorder (ASD), Neurodevelopmental Conditions |
| Intervention | BlinkLab Dx1; Retrospective Neurodevelopmental Diagnostic Assessment |
| Status | Recruiting |
| Participants | 1,000 |
| Est. Completion | 1 Sept 2026 |
| Last Updated | 15 May 2026 |
Primary Outcome
Sensitivity of BlinkLab Dx1; Specificity of BlinkLab Dx1
Eligibility Criteria
Inclusion Criteria
Inclusion Criteria: 1. Age: Children between 2 to 11 years old 2. Parent/Caregiver/Healthcare Provider Concern: The child has received a diagnostic outcome of a neurodevelopmental assessment based on DSM-5 criteria within the past 12 months. 3. Language Proficiency: Parents and subjects must have functional English capability in the home environment. 4. Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF). 5. Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App. Exclusion Criteria: 1. Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app. 2. Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study. 3. Location of at home testing: Not being able to complete all remote at-home study sessions within the US. 4. History of audiogenic seizures: Participants with a known history of seizures that are triggered by auditory stimuli, including reflex or startle epilepsy provoked by sounds (audiogenic seizures), or any other form of sound-induced epilepsy.
Trial Sites
Countries
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