A Repeatability and Reproducibility Study of the EarliPoint™ Device (RnR)

A Repeatability and Reproducibility Study of the EarliPoint™ Device in Pediatric Subjects 16-30 Months of Age

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder (ASD)
• Intervention / Treatment: Device: EarliPoint

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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 months (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• Children between 16 and 30 months of age.
• No acute illnesses by physical observation.
• Normal or corrected-to-normal vision, and normal or corrected-to-normal hearing.
• Communicate meaningfully with patent in English, and the principal investigator /the study team.
• Parent or legal guardian is able to read and understand the Informed Consent Form.
• Parent voluntarily provides written informed consent.

Exclusion Criteria:

• Genetic disorders (e.g., Fragile X, Williams Syndrome, Tuberous Sclerosis, muscular Dystrophy, Neurofibromatosis, Down Syndrome).
• History or presence of a clinically significant medical disease or a mental state that might confound the study result as assessed by the investigator, such as severe hearing or visual impairment; or uncontrolled epilepsy or seizure disorder, et al.
• Acute exacerbations of chronic illnesses likely to prevent successful data collection.
• Receiving therapies that may affect vision.
• Therapies that may affect the ability to focus.
• Known allergies or sensitivity to the plastic, leather, or metal components.
• Unable or unwilling to sit in a child safety seat.
• Use of any investigational drug, therapies or diagnostic device within the past 14 days.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The EarliPoint Device repeatability	EarliPoint Device repeatability agreement in producing binary diagnostic outcomes (clinically-positive or negative for ASD) between multiple measurements per subject conducted with the same device (i.e., intra-device agreement);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).	Anticipated in about 6 months
The EarliPoint Device reproducibility	EarliPoint Device reproducibility agreement in producing binary diagnostic outcomes (clinically-positive or negative for ASD) between single measurements per subject conducted with multiple devices (i.e., inter-device agreement);	Anticipated in about 6 months
The repeatability variance of the underlying EarliPoint Device	Repeatability variance of the underlying EarliPoint Device ASD presence metric (this metric is a continuous score underlying the binary diagnostic outcome: values less than or equal to 0 indicate a patient has ASD [clinically-positive], values greater than 0 indicate a patient does not have ASD [clinically-negative]);	Anticipated in about 6 months
The reproducibility variance of the underlying EarliPoint Device	reproducibility variance of the underlying EarliPoint Device ASD presence metric (this metric is a continuous score underlying the binary diagnostic outcome: values less than or equal to 0 indicate a patient is ASD positive, values greater than 0 indicate a patient is ASD negative).	Anticipated in about 6 months

Collaborators and Investigators

• Sponsor: EarliTec Diagnostics, Inc
• Investigators: Study Chair: Sew-Wah Tay, EarliTec Diagnostics, Inc

Publications and helpful links

General Publications

• Jones W, Klaiman C, Richardson S, Lambha M, Reid M, Hamner T, Beacham C, Lewis P, Paredes J, Edwards L, Marrus N, Constantino JN, Shultz S, Klin A. Development and Replication of Objective Measurements of Social Visual Engagement to Aid in Early Diagnosis and Assessment of Autism. JAMA Netw Open. 2023 Sep 5;6(9):e2330145. doi: 10.1001/jamanetworkopen.2023.30145.
• Jones W, Klaiman C, Richardson S, Aoki C, Smith C, Minjarez M, Bernier R, Pedapati E, Bishop S, Ence W, Wainer A, Moriuchi J, Tay SW, Klin A. Eye-Tracking-Based Measurement of Social Visual Engagement Compared With Expert Clinical Diagnosis of Autism. JAMA. 2023 Sep 5;330(9):854-865. doi: 10.1001/jama.2023.13295.

Helpful Links

• EarliPoint Evaluation for Autism Spectrum Disorder

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): November 17, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pediatric; Diagnosis; EarliPoint
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: CLN-1001-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to share individual participant data (IPD) to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No