Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-11
SponsorBlinklab Limited
About this trial
This observational study aims to evaluate how patterns of behavioral and sensorimotor responses measured using the BlinkLab Dx1 smartphone application relate to autism diagnoses in children ages 2 to 11. BlinkLab Dx1 is a non-invasive, smartphone-based application under development as a diagnostic aid for healthcare providers assessing autism.
In this study, children who have undergone a neurodevelopmental assessment within the past 12 months will complete two short, video-based sessions using the BlinkLab Dx1 app. The app presents visual and auditory stimuli and records reflexive sensorimotor responses and patterns of repetitive behavior. Additionally, primary caregivers will answer a short questionnaire in the app about symptoms and development. Information about prior neurodevelopmental assessments, including documented DSM-5-based diagnoses from routine clinical practice, will be collected retrospectively.
The study will examine how the app's neurobehavioral measurements relate to previously assigned clinical diagnoses. These paired data will be used to develop and evaluate a machine learning-based algorithm using separate training and testing datasets to assess whether patterns measured by BlinkLab Dx1 can help distinguish children with autism from children without an autism diagnosis.
This study does not involve any treatment or medical intervention.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: Children between 2 to 11 years old
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.
Language Proficiency: Parents and subjects must have functional English capability in the home environment.
Informed Consent: Parents must be able to read, understand, and voluntarily sign the Informed Consent Form (ICF).
Disqualifiers
Device Compatibility: Parents without smartphone capabilities necessary for using the BlinkLab app.
Previous Enrollment: Subjects who have been previously enrolled in any BlinkLab clinical study.
Location of at home testing: Not being able to complete all remote at-home study sessions within the US.
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 population
Children aged 2-11 years of which the parents/caregivers and/or pediatrician (or other primary care provider) have raised concerns regarding their neurodevelopment and have undergone neurodevelopmental assessment in the last 12 months that would allow diagnosing any neurodevelopmental condition according to DSM5 criteria.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
BlinkLab Dx1
Diagnostic testBlinkLab Dx1 is a machine learning-based algorithm that generates a continuous score reflecting likelihood of autism from neurobehavioral responses (including measures such as pre-pulse inhibition and habituation, motor activity, and vocalizations) recorded during standardized video-watching sessions in a mobile application. Pre-specified thresholds, determined during model development and fixed prior to evaluation in the independent test dataset, are applied to categorize results as " Positive for autism", "Intermediate" or "Nagative for autism". Results in the intermediate category are considered indeterminate and are excluded from primary diagnostic performance analyses, which are based on participants with definitive positive or negative test results.
Retrospective Neurodevelopmental Diagnostic Assessment
BehavioralThe clinical reference standard is a retrospective neurodevelopmental diagnostic assessment conducted within 12 months prior to enrollment, based on DSM-5 criteria. Participants are classified as having or not having an autism diagnosis based on the documented diagnostic conclusions of these assessments.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Model Development Group - Children evaluated for neurodevelopmental conditions.2 interventions
Group B: Model Testing Group - Children evaluated for neurodevelopmental conditions.2 interventions
Trial outcomes
Primary outcomes
1
Sensitivity of BlinkLab Dx1
Sensitivity of BlinkLab Dx1, defined as the proportion of participants with a positive clinical reference standard diagnosis of autism who are correctly identified as positive by the index test.
Time frame
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)2
Specificity of BlinkLab Dx1
Specificity of the BlinkLab Dx1 algorithm, defined as the proportion of participants without a clinical reference standard diagnosis of autism who are correctly identified as negative by the index test.
Time frame
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)Secondary outcomes
1
Adverse Events
A qualitative description of any adverse events that occurred during the study from the time of informed consent until the completion of the diagnostic evaluation.
Time frame
During individual enrollment period (up to 30 days)2
Usability
The usability of the device for parents/caregivers in relation to the use-related risk analysis identified risks.
Time frame
During the individual enrollment period (up to 30 days)3
Autism Symptom Severity
Based on prospectively collected SRS-2 questionnaire scores and retrospectively collected standardized autism assessment results documented in the neurodevelopmental assessment report.
Time frame
Baseline (including neurodevelopmental assessment data from up to 12 months prior to enrollment and a single SRS-2 assessment collected once during the enrollment period [up to 30 days after enrollment])4
Positive Predictive Value (PPV) of BlinkLab Dx1
Positive predictive value, defined as the proportion of participants with a positive BlinkLab Dx1 test result who have a positive clinical reference standard diagnosis of autism.
Time frame
Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)Other outcomes
1
Timing Task Performance
Performance on the BlinkLab timing task and its relation with ADHD symptom severity as measured with the modified Vanderbilt ADHD Diagnostic Parent Rating Scale (VADRS)
Time frame
Single time point during enrollment period (up to 30 days after enrollment)2
Go/No-Go Taks Performance
Performance on the Blinklab go/no-go task and its relation with ADHD symptom severity as measured with the VADRS.
Time frame
Single time point during enrollment period (up to 30 days after enrollment)3
Latency Task Performance
Performance on the Blinklab latency task and its relation with ADHD symptom severity as measured with the VADRS.
Time frame
Single time point during enrollment period (up to 30 days after enrollment)Sponsors and contacts
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Source ClinicalTrials.gov