Computer-based Social Skills Training for Autism Spectrum Disorder

Autism Spectrum Disorder Clinical Trial

Official title:

Computer-based Social Skills Training for Autism Spectrum Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03672344
• Other study ID #: 08012018A
• Status: Completed
• Phase: N/A
• Start date: August 25, 2018
• Est. completion date: February 19, 2020

Study information

• Verified date: June 2022
• Source: BioStream Technologies, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: February 19, 2020
• Est. primary completion date: February 19, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Nashoba Learning Group, Inc.	Bedford	Massachusetts
United States	Connect Plus Therapy, Inc.	Cherry Hill	New Jersey
United States	Y.A.L.E. School	Cherry Hill	New Jersey
United States	Partners in Learning, Inc.	Clementon	New Jersey
United States	The Pathway School	Jeffersonville	Pennsylvania
United States	Els for Autism Foundation	Jupiter	Florida
United States	Positive Behavior Supports Corporation	Melbourne	Florida
United States	Positive Behavior Supports Corporation	Miami	Florida
United States	Milestones Behavioral Services	Orange	Connecticut
United States	Mary E. Keefe	Point Pleasant Beach	New Jersey
United States	Positive Behavior Supports Corporation	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
BioStream Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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