Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder

NCT ID: NCT02488226

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2016-12-31

Brief Summary

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.

Detailed 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.

Conditions

Autism Spectrum Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Gaze Contingent

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.

Group Type: EXPERIMENTAL

Gaze-contingent eye-tracking technology

Intervention Type: OTHER

When participants look away from a prototypical or expected norm, their gaze patterns are redirected to those prototypical locations.

Control Condition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gaze-contingent eye-tracking technology

When participants look away from a prototypical or expected norm, their gaze patterns are redirected to those prototypical locations.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Frederick Shic

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frederick Shic, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Child Study Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1306012246

Identifier Type: -

Identifier Source: org_study_id