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

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gaze-contingent eye-tracking technology
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder

Eligibility Criteria

18 Months - 60 Months (Child)All SexesDoes not accept 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.

Sites / Locations

  • Yale Child Study Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Gaze Contingent

Control Condition

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 24, 2015
Last Updated
March 3, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02488226
Brief Title
Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder
Acronym
ASD
Official Title
Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gaze Contingent
Arm Type
Experimental
Arm 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.
Arm Title
Control Condition
Arm Type
No Intervention
Arm Description
Participants will view unaltered social videos which do not change based on where the participant is looking.
Intervention Type
Other
Intervention Name(s)
Gaze-contingent eye-tracking technology
Intervention Description
When participants look away from a prototypical or expected norm, their gaze patterns are redirected to those prototypical locations.
Primary Outcome Measure Information:
Title
Gaze behavior during eye tracking tasks measured by standard eye-tracking analysis protocols
Description
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.
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Behavior during real-world interactions measured by coding of video recordings
Description
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.
Time Frame
1-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Shic, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Child Study Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

12. IPD Sharing Statement

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Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder

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