A Repeatability and Reproducibility Study of the EarliPoint™ Device
Condition: Autism Spectrum Disorder (ASD)
MeSH terms: Autism Spectrum Disorder
Study type: Observational

Summary: 
      The study is a prospective randomized repeatability and reproducibility (R&R) study of the
      EarliPoint DeviceTM in pediatric subjects 16-30 months of age. The study will enroll subjects
      who are both clinically-positive and clinically-negative for ASD.

      The study will be conducted at a single center in the US. The Study consists of a screening
      period in order to review the subject's medical history to determine subject eligibility,
      followed by a device administration period during which subjects will undergo testing with
      the EarliPoint Devices and Expert Clinician Diagnosis (ECD) procedures to determine if they
      are clinically-positive or clinically-negative for ASD.
    

Detailed description: 
      Subjects will undergo testing with the same two (2) devices, with one (1) testing session per
      device per subject, with each testing session yielding three (3) measurements per endpoint
      per subject, for a total of six (6) measurements per endpoint for each subject enrolled. The
      order in which the subjects receive testing with each device will be randomized so that the
      same device is not always used first or last for each subject.

      The primary objectives of this study are to quantify the repeatability variability and
      reproducibility variability of all of the EarliPoint device's continuous valued outputs: the
      underlying continuous score used to classify patients into the binary diagnostic
      classification of either clinically-positive or clinically-negative for autism spectrum
      disorder (ASD) as well as each of the three EarliPoint Device severity scores (the social
      disability index, verbal ability index, and nonverbal ability index).

      The secondary objectives of this study are to quantify the repeatability and reproducibility
      variability in producing each of the three EarliPoint Device severity scores: the social
      disability index, verbal ability index, and nonverbal ability index.
    

Intervention name(s): EarliPoint
Intervention type(s): Device
Intervention description(s): EarliPoint is a non-invasive diagnostic device for ASD
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Toddlers and young children will be enrolled in this study, as the aim of this research is
        to examine repeatability of eye-tracking measures in children aged 16-30 months.
        Precautions will be taken when working with young children. Our clinicians and research
        staff are well trained and experienced in working with children and families with some
        level of anxiety.

        All subject's parent or legal guardian will be consented to the study. No protocol-specific
        procedures, including screening, will be performed until the parent has signed and dated
        the consent form. Subjects will also satisfy the inclusion and exclusion criteria in order
        to be enrolled in the study.
      
Keywords: EarliPoint; Pediatric; Diagnosis