Dynamic Quantification of Social-Visual Engagement in Autism Spectrum Disorder (ASD)

NCT05806216 | Completed FDA Device

• 1 other identifier: CLN-1005-02
• Study Type: observational
• Target: 929
• Locations: 1 country
• Sites: 9

Brief Summary

The goal of this clinical study is to learn about the utility and performance of the EarliPoint System (™): Evaluation for Autism Spectrum Disorder to diagnose and assess autism spectrum disorder (ASD) in children ages 31-96 months (2.5 - 7 years chronological age). The main questions it aims to answer are:

1. 1.To determine the sensitivity and specificity of the EarliPoint device (test) compared to Expert Clinician Diagnosis (ECD) using gold-standard clinical reference assessments in the target age-expanded population.
2. 2.To determine the association between the EarliPoint Verbal Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).
3. 3.To determine the association between the EarliPoint Nonverbal Ability Index score and the clinical measures of non-verbal abilities as measured by the Differential Ability Scales (DAS-II).
4. 4.To determine the association between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-II) Overall Total Score.
5. 5.To determine the association between the EarliPoint Expressive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).
6. 6.To determine the association between the EarliPoint Receptive Language Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (DAS-II).
7. 7.To estimate the incidence of adverse device effects associated with the use of the EarliPoint device.

Conditions

Autism Spectrum Disorder; Autism

Keywords

autism spectrum disorder; autism; ASD; autism in children; autism spectrum disorder in children; Dynamic Quantification of Social Visual Engagement; DQSVE; EarliPoint System: Evaluation for Autism Spectrum Disorder; EarliPoint; developmental delay

Outcome Measures

Primary Outcomes (2)

• EarliPoint sensitivity

  The sensitivity of the EarliPoint device relative to the Clinically Certain-Expert Clinician Diagnosis (CC-ECD), defined as the proportion of clinically positive subjects for whom both the EarliPoint and CC-ECD diagnoses are positive.

  at baseline

• EarliPoint specificity

  The specificity of the EarliPoint device relative to the CC-ECD, defined as the proportion of clinically negative subjects for whom the EarliPoint and CC-ECD procedure are negative.

  at baseline

Secondary Outcomes (6)

• EarliPoint Social Disability Index Score

  at baseline

• EarliPoint Verbal Ability Index score

  at baseline

• EarliPoint Receptive Language Ability Index Score

  at baseline

• EarliPoint Expressive Language Ability Index score

  at baseline

• EarliPoint Nonverbal Ability Index score

  at baseline

Other Outcomes (5)

• Negative Predictive Value (NPV)

  at baseline

• Positive Predictive Value (PPV)

  at baseline

• False Negative Rate (FNR)

  at baseline

Study Arms (2)

2a - Model Development

Enrollment for the purposes of training the EarliPoint system data models in children ages 31-84 months suspected of autism spectrum disorder or related developmental delays or those who are typically developing.

Device: EarliPoint Diagnosis; Behavioral: Clinically Certain Expert Clinician Diagnosis (CC-ECD)

2b - Model Testing

Enrollment for the purposes of testing/validating the EarliPoint system data models in children ages 31-84 months suspected of autism spectrum disorder or related developmental delays or those who are typically developing.

Device: EarliPoint Diagnosis; Behavioral: Clinically Certain Expert Clinician Diagnosis (CC-ECD)

Interventions

EarliPoint Diagnosis DEVICE

Diagnosis by the EarliPoint System: Evaluation for Autism Spectrum Disorder

Also known as: EarliPoint

2a - Model Development; 2b - Model Testing

Clinically Certain Expert Clinician Diagnosis (CC-ECD) BEHAVIORAL

Diagnosis by an expert clinician using gold standard developmental assessment tools.

Also known as: CC-ECD

2a - Model Development; 2b - Model Testing

Eligibility Criteria

• Age: 31 Months - 84 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children ages 31-84 months who are suspected of having autism spectrum disorder or related developmental delays and those who are typically developing.

You may qualify if:

• Male or female individuals between the ages of 31 - 84 months (2.5 - 7 years chronological age) at the time of consent.
• Generally healthy with no acute illnesses.
• Normal or corrected-to-normal vision with visual acuity and oculomotor function sufficient to watch short videos.
• Hearing adequate to hear information presented in age-appropriate videos of social interactions.
• Subject and parent (or legally authorized representative) are able and agree to attend the required study visit and complete the full battery of psychometric assessments and questionnaires (electronically or in-person where required).
• Subject's parent (or legally authorized representative) can understand information, instructions, and videos presented in the English language.
• Subject's parent (or legally authorized representative) can read and understand the Informed Consent Form (ICF).
• Subject's parent (or legally authorized representative) provides written informed consent allowing the child subject to participate in the study. NOTE: where able, the child subject should also provide assent.

You may not qualify if:

• Known genetic disorders (e.g., Fragile X, Williams Syndrome, Tuberous Sclerosis, Muscular Dystrophy, Neurofibromatosis, Down Syndrome).
• Severe hearing or visual impairment (e.g., congenital nystagmus, congenital cataracts, previous diagnosis of severe hearing deficits by otoacoustic emissions or auditory brainstem response), which in the opinion of the investigator, would limit the child from completing the EarliPoint eye-tracking procedure or clinical reference assessments. (Note: Corrective lenses are allowable up to a prescription of +/- 5.0.)
• Acute illnesses likely to prevent successful or valid data collection, i.e., conjunctivitis, fever, uncontrolled allergy symptoms, etc.
• Subject has an uncontrolled seizure disorder.
• History or presence of a clinically significant medical disease or a mental state that might confound the study or be detrimental to the subject in the opinion of the investigator.
• Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection.
• Receiving therapies that may affect the subject's vision, (i.e., currently receiving or have received the following therapies within 2 weeks of screening: topiramate, chlorpromazine, thioridazine, prednisone, prednisolone (including ophthalmic solutions and ointments), diphenhydramine, or hydroxyzine; or have received ophthalmic antibiotics within 3 days of screening: tobramycin, ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin and ofloxacin solutions and/or bacitracin ointment).
• Receiving therapies that may affect the subject's ability to focus attention on the videos, (i.e., if on central nervous system stimulants, Central Nervous System (CNS) depressants, or anticonvulsants, dose must have been stable for at least 2 weeks).
• Subject is unable or unwilling to undergo EarliPoint testing for up to 20 minutes per assessment (e.g., child has frequent tantrums and tantrums do not subside within 5 minutes).
• In the opinion of the investigator, the subject and/or parent (or legally authorized representative) are unable, unwilling, or unlikely to comply with all study required procedures and follow-up assessments or to complete the full battery of psychometric assessments (electronically or in-person where required).
• Subject is receiving or plans to receive any investigational drug or device for the duration of their participation in this study.
• In the opinion of the Investigator, subject is not a suitable candidate for participation in a research study (NOTE: reason must be specified).

Sponsors & Collaborators

• EarliTec Diagnostics, Inc: lead

Study Sites (9)

Southwest Autism Research and Resource Center

Phoenix, Arizona, 85006, United States

Location

Emory University - Marcus Autism Center

Altanta, Georgia, 30329, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

ThompsonCenter for Autism & Neurodevelopment; University of Missouri

Columbia, Missouri, 65211, United States

Location

Monroe-Meyer Institute for Genetics and Rehabilitation / University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98115, United States

Location

Related Publications (2)

• 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.

  PMID: 37668621 BACKGROUND

• 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.

  PMID: 37669054 BACKGROUND

Related Links

• EarliPoint Evaluation For Autism Spectrum Disorder

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder; Learning Disabilities

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• John Reviere

  EarliTec Diagnostics, Inc

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: April 10, 2023
• Study Start: August 23, 2023
• Primary Completion: March 27, 2025
• Study Completion: August 31, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)