Tracking Intervention Effects With Eye Tracking

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Pivotal Response Treatment

• Study Type: Interventional
• Enrollment (Actual): 76
• 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: 4 years to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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>50. 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

  1. 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,
  2. hearing loss or other severe sensory impairment,
  3. history of significant head trauma or serious brain or psychiatric illness,
  4. parents/caregivers who do not speak fluent English,
  5. parents/caregivers who have previous training in PRT
  6. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: PRT; Children with ASD who are currently receiving PRT treatment.	Behavioral: Pivotal Response Treatment; Pivotal response treatment (PRT) is an empirically validated behavioral treatment for individuals with ASD that has its foundation in principles of Applied Behavioral Analysis. It was designed to improve social communication skills by addressing core deficits in social motivation or pivotal responses. By working specifically with each child's natural motivations, PRT focuses on naturalistic, functional skills, as opposed to rote skills. In this study, participants randomized to the PRT group will receive 6 hours of direct PRT, across three sessions per week, provided by Dr. Ventola's clinical team. Parents will have an additional one-hour session per week focused on PRT parent training using a practice-with-feedback model. Specific intervention goals in our target population include: Speech to respond to inquiries, Speech to inquire, Speech to comment, Reciprocal conversation, Monitor nonverbal information, and Perspective taking.
No Intervention: Wait List / Non-Treatment Control; Children with ASD who are not currently receiving PRT treatment.
No Intervention: Typically Developing; Children without ASD or developmental delay.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory Eye Tracking Measuring Longitudinal Change	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.	16 Weeks
Home-Based Eye Tracking	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	16 Weeks
Longitudinal Change in Autism Symptom Severity	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).	16 Weeks

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Simons Foundation
• Investigators: Principal Investigator: Frederick Shic, PhD, Yale University; Principal Investigator: Pamela Ventola, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: August 3, 2016
• First Posted (Estimate): August 4, 2016

Study Record Updates

• Last Update Posted (Actual): March 9, 2020
• Last Update Submitted That Met QC Criteria: March 4, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: 1106008625a; 383661 (Other Grant/Funding Number: Simons Foundation Autism Research Initiative)