An observational study in Autism Spectrum Disorder and Autism, sponsored by EarliTec Diagnostics, Inc. Completed at 9 sites in United States. Open to participants aged 31 Months to 84 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by EarliTec Diagnostics, Inc · Observational
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:
This is a prospective, multi-center, double-blind, within-subject comparison study of Dynamic Quantification of Social-Visual Engagement (DQSVE) for diagnosis of ASD and/or related developmental delays (DD) in children ages 31 - 96 months (2.5 - 7 years chronological age). The study will enroll children suspected to have ASD (ASD-positive) and those who do not have ASD (ASD-negative). Eligible participants who sign the Informed Consent Form will be consecutively screened at each study site and enrolled in the appropriate subject group (either suspected ASD/DD or non-ASD).
The main questions it aims to answer are:
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's enrollment of 929 is above the median of 101 across 189 observational studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →EarliTec Diagnostics, Inc is the lead sponsor of 4 studies on the registry; none are open to participants now.
Compared within Autistic Disorder, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Autism Spectrum Disorder. The counts are of registry records indexed under each term, refreshed daily. How we classify →
children ages 31-84 months who are suspected of having autism spectrum disorder or related developmental delays and those who are typically developing.
Subjects must meet all the following inclusion criteria to participate in this study.
Subjects who meet any of the following exclusion criteria are not eligible to participate in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Diagnosis by the EarliPoint System: Evaluation for Autism Spectrum Disorder
Also known as: EarliPoint
Diagnosis by an expert clinician using gold standard developmental assessment tools.
Also known as: CC-ECD
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.
Time frame: 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.
Time frame: at baseline
EarliPoint Social Disability Index Score
The Correlation between the EarliPoint Social Disability Index score and the Autism Diagnostic Observation Schedule, second edition (ADOS-2) Overall Total Score.
Time frame: at baseline
EarliPoint Verbal Ability Index score
The correlation between the EarliPoint Verbal Ability Index score and the clinical measures of verbal ability as measured by the Differential Ability Scales (Verbal Ability Cluster).
Time frame: at baseline
EarliPoint Receptive Language Ability Index Score
The correlation between the EarliPoint Receptive Language Ability Index Score and the Differential Ability Scales (Verbal Comprehension Sub-scale).
Time frame: at baseline
EarliPoint Expressive Language Ability Index score
The correlation between the EarliPoint Expressive Language Ability Index score and the clinical measures of expressive language ability as measured by the Differential Ability Scales (Naming Vocabulary Subscale).
Time frame: at baseline
EarliPoint Nonverbal Ability Index score
The correlation between the EarliPoint Nonverbal Ability Index score and the clinical measures of nonverbal abilities as measured by the Differential Abilities Scales (nonverbal ability cluster).
Time frame: at baseline
Adverse Device Effects
The occurrence of adverse device effects associated with the use of the EarliPoint device.
Time frame: at baseline
Negative Predictive Value (NPV)
The proportion of EarliPoint negative subjects who also received a negative clinically certain expert clinician diagnosis.
Time frame: at baseline
Positive Predictive Value (PPV)
The proportion of the EarliPoint positive subjects who also received a positive clinically certain expert clinician diagnosis
Time frame: at baseline
False Negative Rate (FNR)
False negative rate defined as 1-sensitivity.
Time frame: at baseline
False Positive Rate (FPR)
False positive rate defined as 1-specificity.
Time frame: at baseline
Diagnostic Accuracy
Diagnostic accuracy defined as the total number of subjects with matching CC-ECD and EarliPoint results divided by the number of subjects.
Time frame: at baseline
Plan to share: No
Ran from Aug 2023 to primary completion in Mar 2025, 19 months.
Of 65 observational studies under Autistic Disorder, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 120. This study's 19 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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EarliTec Diagnostics, Inc