Tracking Intervention Effects With Eye Tracking

NCT ID: NCT02856061

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PRT

Children with ASD who are currently receiving PRT treatment.

Group Type: OTHER

Pivotal Response Treatment

Intervention Type: 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.

Wait List / Non-Treatment Control

Children with ASD who are not currently receiving PRT treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Typically Developing

Children without ASD or developmental delay.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

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

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.

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Simons Foundation

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick Shic, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Pamela Ventola, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Child Study Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

383661

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1106008625a

Identifier Type: -

Identifier Source: org_study_id