Back to resultsTracking Intervention Effects With Eye Tracking
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pivotal Response Treatment
Sponsored by
About this trial
This is an interventional other trial for Autism Spectrum Disorder
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>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
- 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.
Sites / Locations
- Yale Child Study Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
No Intervention
No Intervention
Arm Label
PRT
Wait List / Non-Treatment Control
Typically Developing
Arm Description
Children with ASD who are currently receiving PRT treatment.
Children with ASD who are not currently receiving PRT treatment.
Children without ASD or developmental delay.
Outcomes
Primary Outcome Measures
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.
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
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02856061
First Posted
July 12, 2016
Last Updated
March 4, 2020
Sponsor
Yale University
Collaborators
Simons Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02856061
Brief Title
Tracking Intervention Effects With Eye Tracking
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
Simons Foundation
4. Oversight
5. Study Description
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.
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
None (Open Label)
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PRT
Arm Type
Other
Arm Description
Children with ASD who are currently receiving PRT treatment.
Arm Title
Wait List / Non-Treatment Control
Arm Type
No Intervention
Arm Description
Children with ASD who are not currently receiving PRT treatment.
Arm Title
Typically Developing
Arm Type
No Intervention
Arm Description
Children without ASD or developmental delay.
Intervention Type
Behavioral
Intervention Name(s)
Pivotal Response Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Laboratory Eye Tracking Measuring Longitudinal Change
Description
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.
Time Frame
16 Weeks
Title
Home-Based Eye Tracking
Description
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
Time Frame
16 Weeks
Title
Longitudinal Change in Autism Symptom Severity
Description
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).
Time Frame
16 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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>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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick Shic, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pamela Ventola, PhD
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
Learn more about this trial
Tracking Intervention Effects With Eye Tracking
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