SenseToKnow Autism Screening Device Validation Study

Study Overview
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Brief Summary
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This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the detection of autism spectrum disorder in children 16-36 months of age.

Detailed Description
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This is a pivotal, prospective, double-blind, study to evaluate the sensitivity and specificity of the SenseToKnow app for the classification of autism spectrum disorder when administered by parents in a sample of patients 16-36 months of age. The trial design is a non-interventional cross-sectional study comparing the SenseToKnow app classification of autism spectrum disorder (autism) versus non-autism with the patient's diagnostic status based on expert clinical diagnosis in a population of pediatric patients.

Official Title
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SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development

Conditions
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Autism, Autism Spectrum Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Duke Health pediatric patient at enrollment 16-<37 months of age at enrollment Parent/legal guardian speaks English or Spanish Parent/legal guardian understands and voluntarily provides informed consent Exclusion Criteria: Severe motor impairment that precludes study measure completion Known genetic disorders Severe hearing or visual impairment as determined on physical examination according to parent report Acute illnesses likely to prevent successful or valid data collection Uncontrolled epilepsy or seizure disorder History or presence of a clinically significant medical disease, or a mental state that could confound the study or be detrimental to the subject as determined by the investigator Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection Receiving therapies that affect vision Parent/legal guardian and/or investigator believes that the child will be unable/unwilling to sit in the parent's lap to watch the app videos Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment Participants who are otherwise judged as unable to comply with the protocol by the investigator Any other factor that the investigator feels would make the study measures invalid

Ages Eligible for Study
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Minimum Age: 16 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients, 16-37 months of age, recruited through pediatric medical clinics<br>Consecutive pediatric participants will be recruited and enrolled via > 6 participating sites comprised of pediatric medical clinics (e.g., primary care and family medicine clinics) that are part of the broader Duke University Health System (DUHS) located in North Carolina. Enrollment will proceed until the targets of N = 150 participants diagnosed with autism spectrum disorder and N = 200 without autism are reached. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of SenseToKnow for autism detection | Sensitivity = #participants positive for autism on both SenseToKnow and expert clinical diagnosis / #participants positive for autism on both SenseToKnow and expert clinical diagnosis + #participants negative for autism on SenseToKnow who were positive for autism by expert clinical diagnosis | Will be calculated based on data from Baseline/Timepoint 1 | 
| Specificity of SenseToKnow for autism detection | Specificity = #participants negative for autism on both SenseToKnow and expert clinical diagnosis / #participants negative for autism on both SenseToKnow and expert clinical diagnosis + #participants positive for autism on SenseToKnow who were negative for autism by expert clinical diagnosis | Will be calculated based on data from Baseline/Timepoint 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Predictive Value of SenseToKnow (with and without adjustment for population prevalence) | The likelihood that a participant with a positive test result has a diagnosis of autism. | Will be calculated based on data from Baseline/Timepoint 1 | 
| Negative Predictive Value of SenseToKnow (with and without adjustment for population prevalence) | The likelihood that a participant with a negative test result does not have a diagnosis of autism | Will be calculated based on data from Baseline/Timepoint 1 | 
| Receiver Operating Characteristic Curve (ROC) and Area Under the Curve (AUC) with respect to the accuracy of the SenseToKnow app for autism versus non-autism classification | ROC is a graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied. AUC measures the area underneath the entire ROC curve. | Will be calculated based on data from Baseline/Timepoint 1 | 
| Sensitivity of SenseToKnow + Parent Survey for autism detection | Sensitivity = #participants positive for autism on both SenseToKnow+Parent Survey and expert clinical diagnosis / # participants positive for autism on both SenseToKnow+Parent Survey and expert clinical diagnosis + #participants negative for autism on SenseToKnow+Parent Survey who were positive for autism by expert clinical diagnosis | Will be calculated based on data from Baseline/Timepoint 1 | 
| Specificity of SenseToKnow + Parent Survey Survey for autism detection | Specificity = #participants negative for autism on both SenseToKnow+Parent Survey and expert clinical diagnosis / #participants negative for autism on both SenseToKnow+Parent Survey and expert clinical diagnosis + #participants positive for autism on SenseToKnow+Parent Survey who were negative for autism by expert clinical diagnosis | Will be calculated based on data from Baseline/Timepoint 1 | 
| Positive Predictive Value of SenseToKnow + Parent Survey (with and without adjustment for population prevalence) | The likelihood that a participant with a positive test result has a diagnosis of autism. | Will be calculated based on data from Baseline/Timepoint 1 | 
| Negative Predictive Value of SenseToKnow + Parent Survey (with and without adjustment for population prevalence) | The likelihood that a participant with a negative test result does not have a diagnosis of autism | Will be calculated based on data from Baseline/Timepoint 1 | 
| Receiver Operating Characteristic Curve (ROC) and Area Under the Curve (AUC) with respect to the accuracy of the SenseToKnow app + Parent Survey for autism versus non-autism classification | ROC is a graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied. AUC measures the area underneath the entire ROC curve. | Will be calculated based on data from Baseline/Timepoint 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnosis, Digital device