About this trial
This is a single center, intervention study of integrating the eye-tracking (ET) biomarker battery into the existing autism evaluation process at the Riley Early Years Program (EYP). Eligible participants referred for autism testing through EYP will undergo a traditional comprehensive diagnostic assessment by an EYP clinical psychologist.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children born at <37 weeks' gestational age who are 14-48 months old at time of referral
Ambulatory (i.e., cruising, walking)
Without significant visual impairment
Referred for autism testing through EYP (i.e. medium- or high-risk M-CHAT-R/F screening result at 16-22 months corrected age or by referral to Early Years based on caregiver or provider concern for autism)
Disqualifiers
Non-English-speaking participants and families.
Trial design
Single group
Treatments tested in this trial
Eye-tracking device
DeviceEye-tracking device for autism detection
Treatment groups
Trial outcomes
Primary outcomes
Number of participants with usable eye-tracking biomarker data
The number of participants from whom usable eye-tracking biomarker data is collected will be totaled.
Number of participants with suspected autism
The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.
Secondary outcomes
Caregiver attitudes towards use of the eye-tracking device
Caregiver attitudes will be measured toward healthcare devices form. Caregivers will rate their openness to the use of devices or computer programs in medical care and how important the details of using these devices are to them. Participants will respond to questions on a 5 point Likert scale from "Not Important" to "Extremely Important."
Individual and Family Predictors (IFP)
Sociodemographic familial history and medical history information for the infant participant will be collected.
Sponsors and contacts
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Indiana University
Lead sponsor
Indiana University Health
Collaborator
This trial is not recruiting at the moment. You can still explore other options: