Computer-based Social Skills Training for Autism Spectrum Disorder

The primary objective of this study is to evaluate changes in subject performance on social skills assessments after engaging in a gaze-controlled video game that leverages ABA principles of learning, in comparison to an alternative game. The secondary objectives of this study are to evaluate changes in subject gaze patterns during social skills assessments after engaging in the video game, including in comparison to an alternative game and to evaluate possible correlations in changes in social skills assessments with changes in subject game play performance.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Lookware TM; Device: Lookware TM Control Module

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Orange, Connecticut, United States, 06477
      • Milestones Behavioral Services
  • Florida
    • Jupiter, Florida, United States, 33458
      • Els for Autism Foundation
    • Melbourne, Florida, United States, 32901
      • Positive Behavior Supports Corporation
    • Miami, Florida, United States, 33173
      • Positive Behavior Supports Corporation
    • West Palm Beach, Florida, United States, 33409
      • Positive Behavior Supports Corporation
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Nashoba Learning Group, Inc.
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08002
      • Y.A.L.E. School
    • Cherry Hill, New Jersey, United States, 08003
      • Connect Plus Therapy, Inc.
    • Clementon, New Jersey, United States, 08021
      • Partners in Learning, Inc.
    • Point Pleasant Beach, New Jersey, United States, 08742
      • Mary E. Keefe
  • Pennsylvania
    • Jeffersonville, Pennsylvania, United States, 19403
      • The Pathway School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages 4-14.
2. Meets diagnostic criteria for ASD.
3. Estimated intelligence standard score of at least 40 (can be substituted for a receptive language score such as PPVT or use of the Differential Ability Scales, 2nd Edition (DAS-II)).
4. Parent reports difficulty with at least one of two social skills (via modified questions from the Social Responsiveness Scale)
5. English as the child's primary/first language (key measures used in the study do not have alternate language versions).
6. Attains a score equal to or less than 75% correct on the Ekman 60 Faces Test
7. The parent who completes the questionnaires needs to be proficient in English.
8. Has successfully played a video game using a Microsoft Xbox game controller, Sony PlayStation game controller, or other comparable game controller.
9. Parental/guardian permission (informed consent) and if appropriate, child assent.
10. Wi-Fi internet connection at subject's home/school/therapy center/research organization available for use by study laptop computer.

Exclusion Criteria:

1. History of seizures.
2. History of traumatic brain injury or other significant medical or neurological abnormality affecting motor or higher cortical functioning.
3. Certain visual, auditory, DSM 5, or conduct disorders (see below).
4. A visual disorder that cannot be corrected through the use of corrective lenses to a level of 20-40 in both eyes.
5. Use of corrective visual lenses that would significantly impede the valid collection of visual attention and gaze pattern data during dyadic interaction tasks.
6. Auditory impairment (that cannot be corrected by a hearing aid) that would significantly impede the valid collection of test measures.
7. Profound intellectual disability or sensory-motor difficulties that would preclude valid use of diagnostic instruments and/or use of a computer or mobile computing device.
8. A DSM 5 disorder or other psychiatric symptoms that would interfere with the participant's ability to participate in the study (e.g., active psychosis), per parent report.
9. History of one or more psychiatric hospitalizations.
10. Presence of significant symptoms of a conduct disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lookware TM; Lookware TM computer-based video game that requires the subject to engage in social skills related exercises during simulated social interactions with game characters.	Device: Lookware TM; Lookware TM is a computer-based video game that requires the subject engage in social skills related exercises that include certain visual behaviors. These exercises combine techniques from applied behavior analysis (ABA) and use of gaze-contingent eye tracking technology during simulated social interactions with 3D animated characters to target certain social skills deficits in children with autism spectrum disorder (ASD). The game is delivered through a laptop computer, eye tracker, and game controller.
Placebo Comparator: Lookware TM Control Module; Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.	Device: Lookware TM Control Module; Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises. The game is delivered through a laptop computer, eye tracker, and game controller.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ekman-60 Faces Test	The Ekman-60 Faces Test is used to assesses emotion recognition using pictures. In this study, children were presented with 60 faces across 10 actors displaying six basic emotions (i.e., happiness, sadness, disgust, fear, surprise, and anger). Facial expressions are displayed on the computer for five seconds, after which the image disappears, and participants select from a list of emotions which best described the facial expression shown. Correct responses are summed to create a total score with a possible range from 0-60, and higher scores indicate better emotion recognition.	6 Weeks
Social Responsiveness Scale	The Social Responsiveness Scale is used to identify social impairment in children with autism spectrum disorder. The measure consists of five subscales: social motivation; social awareness; social cognition; social communication; and restricted interests and repetitive behavior, each with items scored on a scale from 1 to 4. A total score can be computed by summing scores across subscales, including, or excluding the restricted interests and repetitive behavior subscale. In this study, response options were re-coded from a scale of 1 to 4, to 0 to 3. Scores were then summed across four subscales, excluding the restrictive and repetitive behavior subscale. Possible scores ranged from 0 to 195, with higher scores meaning a better outcome.	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Joint Attention Rating Scale	The Childhood Joint Attention Rating Scale is used to assess joint attention in children with autism spectrum disorder. In this study, we used the asocial subscale, which consists of 14 items on a scale from 0 to 4. Scores were then summed, with a possible range from 0 to 56, and higher scores meant worse joint attention.	6 Weeks

Collaborators and Investigators

• Sponsor: BioStream Technologies, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2018
• Primary Completion (Actual): February 19, 2020
• Study Completion (Actual): February 19, 2020

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Actual): July 15, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 08012018A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No