Clinical trial NCT05874466: SenseToKnow Autism Screening Device Validation Study
Official title: SenseToKnow STAR Study: A Study of Technologies for Assessing Children's Development
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autism
Autism Spectrum Disorder
Keywords: Diagnosis
Digital device
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-05-25
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be patients 16-36 months of age recruited from \> 6 sites comprised of pediatric medical clinics that are part of the broader Duke University Health System in North Carolina.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Duke Health pediatric patient at enrollment
2. 16-\<37 months of age at enrollment
3. Parent/legal guardian speaks English or Spanish
4. Parent/legal guardian understands and voluntarily provides informed consent

Exclusion Criteria:

1. Severe motor impairment that precludes study measure completion
2. Known genetic disorders
3. Severe hearing or visual impairment as determined on physical examination according to parent report
4. Acute illnesses likely to prevent successful or valid data collection
5. Uncontrolled epilepsy or seizure disorder
6. 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
7. Acute exacerbations of chronic illnesses likely to prevent successful or valid data collection
8. Receiving therapies that affect vision
9. 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
10. Parent/legal guardian indicates that they or their child is unwilling or unable to complete the app administration, surveys, or diagnostic assessment
11. Participants who are otherwise judged as unable to comply with the protocol by the investigator
12. Any other factor that the investigator feels would make the study measures invalid

Primary outcomes:
measure: Sensitivity of SenseToKnow for autism detection
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: Specificity of SenseToKnow for autism detection
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
Secondary outcomes:
measure: Positive Predictive Value of SenseToKnow (with and without adjustment for population prevalence)
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: Negative Predictive Value of SenseToKnow (with and without adjustment for population prevalence)
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: 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
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: Sensitivity of SenseToKnow + Parent Survey for autism detection
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: Specificity of SenseToKnow + Parent Survey Survey for autism detection
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: Positive Predictive Value of SenseToKnow + Parent Survey (with and without adjustment for population prevalence)
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: Negative Predictive Value of SenseToKnow + Parent Survey (with and without adjustment for population prevalence)
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
measure: 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
timeFrame: Will be calculated based on data from Baseline/Timepoint 1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Geraldine Dawson, PhD
role: PRINCIPAL_INVESTIGATOR
References: