Online test of BlinkLab Dx1 for autism in kids aged 2–11

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects remote BlinkLab Dx1 measurements during short video sessions and caregiver reports from children who recently had a neurodevelopmental assessment. The app records reflexive sensorimotor responses and patterns of repetitive behavior while children watch and listen to stimuli, and caregivers complete a brief questionnaire. Researchers will compare these digital measurements with DSM-5-based diagnoses from routine care to develop a machine learning model that classifies participants as Positive for autism, Intermediate, or Negative for autism. The primary diagnostic analyses exclude intermediate results to focus on definitive positive or negative classifications. Data are gathered retrospectively for the clinical reference standard and prospectively for the app measurements, with model development and testing done on separate datasets.

Why it matters

Who can join: the full rules

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.

Where it's running

• Remote study conducted nationwide; all participation occurs via smartphone app at home.
  Princeton, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Myrthe J. Ottenhoff, MD, PhD
• Email: study@blinklab.org
• Phone: 908-824-3471

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.