Eye Tracking and Autism in Former Preterm Infants

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-48
SponsorIndiana University

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Eye-tracking device

    Device

    Eye-tracking device for autism detection

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1
2

Number of participants with suspected autism

The number of participants whose eye-tracker data suggest a potential autism diagnosis will be totaled.

Time frame
Day 1

Secondary outcomes

1

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."

Time frame
Day 1
2

Individual and Family Predictors (IFP)

Sociodemographic familial history and medical history information for the infant participant will be collected.

Time frame
Day 1

Other outcomes

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: