Autism Spectrum Disorder
Conditions
Brief summary
The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.
Interventions
DIAGNOSTIC_TESTASD Diagnostic Device
The ASD Diagnostic Device is a machine learning algorithm-based software as a medical device that is incorporated into a parent/caregiver-facing mobile application, the Cognoa App, used outside of a clinical setting
Sponsors
Cognoa, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Participants, care providers, and diagnostic clinicians are blinded to the diagnostic output of the ASD diagnostic device
Eligibility
Sex/Gender
ALL
Age
18 Months to 72 Months
Healthy volunteers
No
Inclusion criteria
* ≥ 18 months of age and \< 72 months of age * Functional English capability in the home environment * Documented parental and/or clinician concern for developmental delay * Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)
Exclusion criteria
* Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia. * Children with known sensory impairment such as deafness or blindness * Children with known physical impairment affecting their ability to use their hands * Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome) * Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X) * Children with microcephaly * Children with history or prior diagnosis of epilepsy or seizures * Children with history of or suspected neglect * Children with history of brain defect, injury or insult requiring interventions such as surgery or chronic medication * Children whose age on the date of enrollment is outside the target age range * Children who have been previously enrolled in any Cognoa clinical study or survey * Children whose medical records had been included in any internal Cognoa training or validation sets
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive and negative predictive value of ASD Dx in relation to clinician diagnostic evaluation | approximately one month |
Countries
United States
Outcome results
None listed