Tracking Intervention Effects With Eye Tracking

NCT02856061 | Completed

• 2 other identifiers: 1106008625a383661
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

PRT

OTHER

Children with ASD who are currently receiving PRT treatment.

Behavioral: Pivotal Response Treatment

Wait List / Non-Treatment Control

NO INTERVENTION

Children with ASD who are not currently receiving PRT treatment.

Typically Developing

NO INTERVENTION

Children without ASD or developmental delay.

Interventions

Pivotal Response Treatment BEHAVIORAL

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.

PRT

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• Simons Foundation: collaborator

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, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

• Pamela Ventola, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: August 4, 2016
• Study Start: January 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: March 9, 2020

Record last verified: 2020-03

Locations

US (1)