Online Evaluation of the Diagnostic Accuracy of BlinkLab's Digital Assessments for Autism

NCT07590973 | Recruiting FDA Device

• 1 other identifier: 08012025
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism; Neurodevelopmental Conditions; Autism Spectrum Disorder; Autism Spectrum Disorder (ASD)

Keywords

Autism Spectrum Disorder; Autism; Autism Diagnosis; Neurodevelopmental Conditions; Pediatric Assessment; Digital Assessment; Mobile Application; Smartphone-based Assessment; Digital Health; Remote Study; Observational Study; Eye Movements; Repetitive Behavior; Reflexive Sensorimotor Behavior; Machine Learning

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)

• 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.

  Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)

Secondary Outcomes (8)

• Adverse Events

  During individual enrollment period (up to 30 days)

• Usability

  During the individual enrollment period (up to 30 days)

• Autism Symptom Severity

  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])

• Positive Predictive Value (PPV) of BlinkLab Dx1

  Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)

• Negative Predictive Value of BlinkLab Dx1

  Baseline (including index test completed during the enrollment period and reference standard diagnosis from assessments conducted within 12 months prior to enrollment)

Other Outcomes (3)

• Timing Task Performance

  Single time point during enrollment period (up to 30 days after enrollment)

• Go/No-Go Taks Performance

  Single time point during enrollment period (up to 30 days after enrollment)

• Latency Task Performance

  Single time point during enrollment period (up to 30 days after enrollment)

Study Arms (2)

Model Development Group - Children evaluated for neurodevelopmental conditions.

Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition.

Diagnostic Test: BlinkLab Dx1; Behavioral: Retrospective Neurodevelopmental Diagnostic Assessment

Model Testing Group - Children evaluated for neurodevelopmental conditions.

Children aged 2-11 who have formally been evaluated for neurodevelopmental conditions in the 12 months prior to the enrollment date. This includes children with and without autism, children with other neurodevelopmental conditions and children eventually not diagnosed with any neurodevelopmental condition. Data collection for this group is blinded.

Diagnostic Test: BlinkLab Dx1; Behavioral: Retrospective Neurodevelopmental Diagnostic Assessment

Interventions

BlinkLab Dx1 DIAGNOSTIC_TEST

BlinkLab 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.

Model Development Group - Children evaluated for neurodevelopmental conditions.; Model Testing Group - Children evaluated for neurodevelopmental conditions.

Retrospective Neurodevelopmental Diagnostic Assessment BEHAVIORAL

The 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.

Model Development Group - Children evaluated for neurodevelopmental conditions.; Model Testing Group - Children evaluated for neurodevelopmental conditions.

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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).
• Videotaping: subjects must be willing to be videotaped during the diagnostic assessment by the BlinkLab App.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blinklab Limited: lead

Study Sites (1)

Remote study conducted nationwide; all participation occurs via smartphone app at home.

Princeton, New Jersey, 08540, United States

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Central Study Contacts

Myrthe J. Ottenhoff, MD, PhD

CONTACT

908-824-3471; study@blinklab.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 15, 2026
• Study Start: February 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)