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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Other: Gaze-contingent eye-tracking technology

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale Child Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Gaze-contingent eye-tracking technology; When participants look away from a prototypical or expected norm, their gaze patterns are redirected to those prototypical locations.
No Intervention: Control Condition; Participants will view unaltered social videos which do not change based on where the participant is looking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gaze behavior during eye tracking tasks measured by standard eye-tracking analysis protocols	Outcome measures for eye-tracking will include the Percentage of Time Spent Looking at Face, Body, and Background regions for stimuli involving people, and Percentage of Time Spent Looking at Activity, People, and Background regions. Percentage of time spent looking at the video (i.e. overall attention less motion, blinks, and inattention) will be calculated. Additional variables specific to the training sessions' adaptive cue condition will include the number of times the stimuli is adapted to redirect attention to locations consistent with the typical viewing pattern) and the amount of time spent in redirection. These will all be assessed by standard eye-tracking analysis protocols.	1-7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior during real-world interactions measured by coding of video recordings	Outcome measures include attention to social interactions and responses bids for engagement in social attention during a live experimental session, as measured by coding of video recordings.	1-7 days

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Frederick Shic, Ph.D., Yale University

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 24, 2015
• First Submitted That Met QC Criteria: July 1, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 1306012246