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Computer-based Social Skills Training for Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lookware TM
Lookware TM Control Module
Sponsored by
BioStream Technologies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

4 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Milestones Behavioral Services
  • Els for Autism Foundation
  • Positive Behavior Supports Corporation
  • Positive Behavior Supports Corporation
  • Positive Behavior Supports Corporation
  • Nashoba Learning Group, Inc.
  • Y.A.L.E. School
  • Connect Plus Therapy, Inc.
  • Partners in Learning, Inc.
  • Mary E. Keefe
  • The Pathway School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lookware TM

Lookware TM Control Module

Arm Description

Lookware TM computer-based video game that requires the subject to engage in social skills related exercises during simulated social interactions with game characters.

Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 11, 2018
Last Updated
June 22, 2022
Sponsor
BioStream Technologies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03672344
Brief Title
Computer-based Social Skills Training for Autism Spectrum Disorder
Official Title
Computer-based Social Skills Training for Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 25, 2018 (Actual)
Primary Completion Date
February 19, 2020 (Actual)
Study Completion Date
February 19, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioStream Technologies, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lookware TM
Arm Type
Active Comparator
Arm Description
Lookware TM computer-based video game that requires the subject to engage in social skills related exercises during simulated social interactions with game characters.
Arm Title
Lookware TM Control Module
Arm Type
Placebo Comparator
Arm Description
Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Intervention Type
Device
Intervention Name(s)
Lookware TM
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Lookware TM Control Module
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ekman-60 Faces Test
Description
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.
Time Frame
6 Weeks
Title
Social Responsiveness Scale
Description
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.
Time Frame
6 Weeks
Secondary Outcome Measure Information:
Title
Childhood Joint Attention Rating Scale
Description
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.
Time Frame
6 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ages 4-14. Meets diagnostic criteria for ASD. 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)). Parent reports difficulty with at least one of two social skills (via modified questions from the Social Responsiveness Scale) English as the child's primary/first language (key measures used in the study do not have alternate language versions). Attains a score equal to or less than 75% correct on the Ekman 60 Faces Test The parent who completes the questionnaires needs to be proficient in English. Has successfully played a video game using a Microsoft Xbox game controller, Sony PlayStation game controller, or other comparable game controller. Parental/guardian permission (informed consent) and if appropriate, child assent. Wi-Fi internet connection at subject's home/school/therapy center/research organization available for use by study laptop computer. Exclusion Criteria: History of seizures. History of traumatic brain injury or other significant medical or neurological abnormality affecting motor or higher cortical functioning. Certain visual, auditory, DSM 5, or conduct disorders (see below). A visual disorder that cannot be corrected through the use of corrective lenses to a level of 20-40 in both eyes. Use of corrective visual lenses that would significantly impede the valid collection of visual attention and gaze pattern data during dyadic interaction tasks. Auditory impairment (that cannot be corrected by a hearing aid) that would significantly impede the valid collection of test measures. 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. 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. History of one or more psychiatric hospitalizations. Presence of significant symptoms of a conduct disorder.
Facility Information:
Facility Name
Milestones Behavioral Services
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
Facility Name
Els for Autism Foundation
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Positive Behavior Supports Corporation
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Positive Behavior Supports Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Positive Behavior Supports Corporation
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Nashoba Learning Group, Inc.
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Facility Name
Y.A.L.E. School
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
Connect Plus Therapy, Inc.
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Partners in Learning, Inc.
City
Clementon
State/Province
New Jersey
ZIP/Postal Code
08021
Country
United States
Facility Name
Mary E. Keefe
City
Point Pleasant Beach
State/Province
New Jersey
ZIP/Postal Code
08742
Country
United States
Facility Name
The Pathway School
City
Jeffersonville
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Computer-based Social Skills Training for Autism Spectrum Disorder

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