Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder

NCT02488226 | Completed

• 1 other identifier: 1306012246
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Behavior during real-world interactions measured by coding of video recordings

  1-7 days

Study Arms (2)

Gaze Contingent

EXPERIMENTAL

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

Control Condition

NO INTERVENTION

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

Interventions

Gaze-contingent eye-tracking technology OTHER

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

Gaze Contingent

Eligibility Criteria

• Age: 18 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale Child Study Center

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Frederick Shic, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: July 2, 2015
• Study Start: June 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 6, 2020

Record last verified: 2020-03

Locations

US (1)