Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder (ASD)

Yale University

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Other: Gaze-contingent eye-tracking technology

Study type: Interventional

Funder types: Other

Identifiers

NCT02488226

1306012246

Details and patient eligibility

About

This project seeks to understand how the gaze behavior of infants and children with or at high risk for autism spectrum disorder (ASD) may be manipulated in the contexts of dynamic social and non-social scenes. The study explores not only the methods which may be most effective in aligning and teaching normative patterns of scene exploration, but also seeks to establish what behavioral characteristics may be most predictive of atypical scanning and atypical learning.

Full description

This study initiates a highly novel line of research which uses adaptive, gaze-contingent, eye-tracking technology to help infants and children with or at high risk for ASD learn to direct their attention to people and their actions in a more typical fashion. This study will begin with a Normative Collection phase, and will conclude with a Gaze-Shaping phase. In the Normative Collection phase, the investigators will examine the gaze behavior of a group of typically developing infants and children with typical development (TD), in order to establish a normative gaze pattern. In the Gaze-Shaping phase, within the same videos shown in the Normative Collection phase, the investigators will highlight selectively targeted people, objects, and activities, in an attempt to shape participants' viewing patterns to match the normative gaze pattern.

Manual coding of live-action interaction probes will provide an additional evaluative measure, allowing the investigators to track real-world (live-action) correlates alongside video-eye-tracking behaviors. In addition, live-action probes may allow the investigators to check for generalization to live interaction with another person (as opposed to gaze behavior when watching videos). In live-action probes, one or two clinical research staff member(s) will interact with each participant (or with each other in front of the participant), in a manner analogous to the actions performed in the training videos.

Please note: The original estimated enrollment as specified to and funded by NIH was 98 participants, but was incorrectly listed on ClinicalTrials.gov as 220 participants reflecting maximal recruitment in this and other ongoing studies.

Enrollment: 81 patients

Sex: All

Ages: 18 to 60 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Between the ages of 18 and 60 months
• Fulfill criteria for autistic disorder or PDD-NOS (Pervasive Developmental Disorder- Not Otherwise Specified) on the Autism Diagnostic Observation Schedule - Module 1
• A diagnosis of autism or PDD-NOS by experienced clinicians

Exclusion criteria

• Gestational age below 32 weeks
• Suspected or diagnosed hearing loss or visual impairment
• History of head trauma with loss of consciousness
• Non-febrile seizure disorders
• Diagnosed neurological abnormality significantly impacting on visual or auditory acuity.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups

Gaze Contingent

Experimental group

Description:

Participants will view social videos using Gaze-contingent eye-tracking technology . If the participants looking patterns deviate from a normative pattern, they will be redirected to the normative point of regard using gaze-contingent cues.

Treatment:

Other: Gaze-contingent eye-tracking technology

Control Condition

No Intervention group

Description:

Participants will view unaltered social videos which do not change based on where the participant is looking.