Skip to main content
Clinical Trials/NCT02856061
NCT02856061
Completed
Not Applicable

Tracking Intervention Effects With Eye Tracking

Yale University1 site in 1 country76 target enrollmentJanuary 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
Yale University
Enrollment
76
Locations
1
Primary Endpoint
Laboratory Eye Tracking Measuring Longitudinal Change
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This pilot study examines concurrent and predictive relationships between eye tracking and clinical outcomes during a 16-week behavioral intervention (PRT) for children with ASD. Eye tracking will be comprised of both laboratory-based measures (using a commercial eye-tracking system) as well as home-based measures (using tablet-based eye tracking systems). The major goals of this study are both to improve our understanding of the potential role of eye tracking in clinical trials and to advance technologies that may further improve the sensitivity, robustness, accessibility, and ultimate utility of eye tracking methodologies.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
March 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Individuals ages 4-7 years diagnosed previously with ASD and meet criteria for ASD when characterized by our research team, English is a language spoken in the family, and Full-scale IQ\>
  • Participants must also complete laboratory and home-based eye tracking sessions, with success determined by the Principal Investigator.

Exclusion Criteria

  • Individuals will be excluded from participation based on the presence of
  • a physical or neurological disorder (e.g., cerebral palsy) which is likely to impact development and learning, as intervention procedures for these individuals may need to be modified beyond the standard approach to address more complex developmental needs,
  • hearing loss or other severe sensory impairment,
  • history of significant head trauma or serious brain or psychiatric illness,
  • parents/caregivers who do not speak fluent English,
  • parents/caregivers who have previous training in PRT
  • individuals who must be excluded from eye tracking. These families will be offered the treatment clinically (i.e., fee-based), and they will be given referrals to outside agencies offering the treatment as well.

Outcomes

Primary Outcomes

Laboratory Eye Tracking Measuring Longitudinal Change

Time Frame: 16 Weeks

A comprehensive laboratory eye-tracking battery will be administered to participants before, at midpoint, and at the end of a 16-week period to assess change over the course of treatment.

Home-Based Eye Tracking

Time Frame: 16 Weeks

Participants will also receive a tablet equipped with eye-tracking paradigms specifically designed for continuous monitoring in homes. Caregivers will be asked to complete a brief questionnaire

Longitudinal Change in Autism Symptom Severity

Time Frame: 16 Weeks

Clinical assessments and caregiver surveys will be administered at baseline. A subset of measures will be administered again post-study. Assessments include the Autism Diagnostic Observation Schedule™ Second Edition (ADOS™-2), Autism Diagnostic Interview™ Revised (ADI™-R), Social Responsiveness Scale™ (SRS™), Repetitive Behaviors Scale - Revised (RBS-R), Differential Ability Scales®-II (DAS-II®), Vineland Adaptive Behavior Scales™ Second Edition (Vineland™-II), and the Child Behavior Checklist (CBCL).

Study Sites (1)

Loading locations...

Similar Trials