Eye Tracking for Autism Detection

(RCFET Trial)

Overseen By Angela R Paxton, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Age, Language, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how eye-tracking technology can help detect autism in young children. Participants will engage in a simple activity where researchers track their eye movements as they view pictures and movies. This non-invasive method gathers data that might improve autism detection. Families with children aged 12 to 48 months visiting certain clinics for developmental evaluations, and who have English- or Spanish-speaking caregivers, might be a good fit for this study. As an unphased trial, this study offers families the chance to contribute to groundbreaking research that could enhance early autism detection methods.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that this eye-tracking method is safe for children?

A previous study found eye-tracking technology to be safe and easy to use. This tool reveals where and how long individuals focus their gaze, highlighting differences in attention. Eye-tracking has been applied to both children with autism and those without. Research has shown that this technology does not cause harm or discomfort. It is non-invasive, requiring no medical procedures or physical contact. Consequently, participants typically find it easy to engage in activities involving eye-tracking. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring eye tracking as a tool for detecting autism, which could revolutionize early diagnosis. Unlike current methods, such as behavioral assessments and parental questionnaires, eye tracking provides an objective and non-invasive way to analyze how children visually engage with their environment. This technique could potentially identify autism earlier and more accurately, allowing for timely interventions that can significantly improve developmental outcomes.

What evidence suggests that this eye-tracking method is effective for autism detection?

Studies have shown that eye-tracking technology can effectively diagnose autism. One study found that eye-tracking data was nearly 100% accurate in distinguishing children with autism from those without. Another study linked specific eye movement patterns to autism diagnoses. Research also shows that eye-tracking provides clear and consistent measurements, aiding early autism detection. In this trial, children undergoing a standard developmental evaluation will participate in a one-time eye-tracking activity to further explore its potential as a valuable tool for identifying autism in children. ^{1 2 6 7 8}

Who Is on the Research Team?

Rebecca R McNally Keehn, PhD, HSPP

Principal Investigator

IU School of Medicine

Are You a Good Fit for This Trial?

This trial is for young children aged 12-48 months who are patients at Riley Hospital for Children in Indiana. They must have caregivers who speak English or Spanish and can give consent. It's not open to kids younger than 12 months, older than 48 months, or those with non-English/Spanish-speaking caregivers.

Inclusion Criteria

My child is between 1 and 4 years old and has an appointment at Riley Hospital.

Children must have a legal guardian that is able to provide consent

Exclusion Criteria

My child is not between 1 and 4 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Developmental Evaluation

Children undergo a standard of care developmental evaluation including a clinical interview and observational measures

1 day

1 visit (in-person)

Eye-Tracking Activity

Participants engage in a one-time eye-tracking activity to view pictures and movies while eye movements are tracked

15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the eye-tracking activity

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eye Tracking

Trial Overview

The study is testing a non-invasive eye-tracking system called Eyelink Portable Duo to see if it can help identify the risk of autism in young children during routine health care visits.

How Is the Trial Designed?

Group I: Children Undergoing Developmental Evaluation Experimental Treatment 1 Intervention

Children undergoing a standard of care developmental evaluation will be enrolled into the study. After the completion of the developmental evaluation, research participation includes a one-time eye-tracking activity in which the child will view a series of different pictures and movies while their eye movements are tracked and recorded.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

A multisite study involving 280 children with autism spectrum disorder (ASD) and 119 typically developing children demonstrated that eye tracking (ET) tasks effectively measure attention to human faces, with the Oculomotor Index of Gaze to Human Faces (OMI) showing strong associations with cognitive and communicative skills in ASD.

The OMI has been accepted into the FDA's Biomarker Qualification program, indicating its potential as a reliable biomarker for clinical trials in ASD, although further research is needed to assess its effectiveness in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The autism biomarkers consortium for clinical trials: evaluation of a battery of candidate eye-tracking biomarkers for use in autism clinical trials. Shic, F., Naples, AJ., Barney, EC., et al.[2023]

In a study involving 74 children (37 with autism spectrum disorder and 37 typically developing), eye tracking revealed that children with ASD had significantly shorter fixation times on key areas of interest while watching a 10-second video.

The analysis showed that fixation times on the mouth and body could accurately distinguish between ASD and typically developing children with an accuracy of 85.1%, indicating that this method could be a promising tool for early detection of autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying Eye Tracking to Identify Autism Spectrum Disorder in Children. Wan, G., Kong, X., Sun, B., et al.[2021]

Eye tracking can effectively identify early signs of autism spectrum disorder (ASD) in young children, such as reduced attention to faces and difficulties in disengaging attention, which can appear as early as the first year of life.

In toddlers with ASD, specific altered looking patterns, particularly towards facial features like the eyes and mouth, as well as reduced responsiveness to biological motion, have been observed, suggesting that eye tracking can provide valuable insights into the neurocognitive aspects of autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye tracking in early autism research. Falck-Ytter, T., Bölte, S., Gredebäck, G.[2021]

Eye-tracking technology is a powerful tool in psychological research, particularly for studying autism spectrum disorders (ASD), as it provides objective measures of gaze behavior that can help identify disorder-specific characteristics and inform treatment strategies.

While eye-tracking can be especially beneficial for assessing young children with ASD, researchers face unique challenges, such as ensuring compliance during tasks and addressing psychosocial factors, which necessitate careful methodological planning to optimize data collection and analysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye tracking young children with autism. Sasson, NJ., Elison, JT.[2021]

The study found that eye-tracking data can be used to automatically detect high-functioning autism in adults with an accuracy of approximately 74%, based on the visual processing differences observed during web page navigation.

Data was collected from 71 participants (31 with autism and 40 controls) across two studies, confirming that distinct gaze patterns exist between adults with and without autism when processing visual information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detecting High-Functioning Autism in Adults Using Eye Tracking and Machine Learning. Yaneva, V., Ha, LA., Eraslan, S., et al.[2021]

The study found that children with autism spectrum disorder (ASD) had significantly smaller baseline pupil sizes compared to both mental age-matched and chronological age-matched controls, suggesting a potential biomarker for ASD.

Using eye-tracking technology, pupil responses during visual scanning could accurately predict group membership in 72% of participants, with 89% accuracy for the ASD group, indicating that pupil size may reflect underlying neurological differences associated with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can pupil size and pupil responses during visual scanning contribute to the diagnosis of autism spectrum disorder in children? Martineau, J., Hernandez, N., Hiebel, L., et al.[2011]

Eye detection and tracking technology has made significant advancements over the past 30 years, but challenges remain due to individual differences in eyes, occlusion, and varying environmental conditions.

The review highlights the need for further theoretical developments in eye detection techniques, as they are crucial for applications in face detection, biometric identification, and human-computer interaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In the eye of the beholder: a survey of models for eyes and gaze. Hansen, DW., Ji, Q.[2010]

This systematic review highlights the variability in eye-tracking protocols and the diversity of stimuli used in research on young children at risk for Autism Spectrum Disorder (ASD), which can affect the reliability of eye-tracking as a screening tool.

The authors emphasize the need for standardized eye-tracking methods and the creation of a publicly available bank of validated stimuli to improve the replicability and effectiveness of future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye-Tracking in Infants and Young Children at Risk for Autism Spectrum Disorder: A Systematic Review of Visual Stimuli in Experimental Paradigms. Mastergeorge, AM., Kahathuduwa, C., Blume, J.[2021]

Citations

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In this prospective diagnostic study, a composite eye-tracking biomarker was associated with a best-estimate clinical diagnosis of autism.

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Applying Eye Tracking with Deep Learning Techniques for ...

The dataset comprises raw eye-tracking data collected from 29 children diagnosed with autism spectrum disorder (ASD) and 30 typically developing (TD) children.

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To aid in early autism diagnosis, eye-tracking measurement of social visual engagement has shown potential as a performance-based biomarker.

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