Computer-based Social Skills Training for Autism Spectrum Disorder

NCT03672344 | Completed Results FDA Device

• 1 other identifier: 08012018A
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 11

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Childhood Joint Attention Rating Scale

  6 Weeks

Study Arms (2)

Lookware TM

ACTIVE COMPARATOR

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 Control Module

PLACEBO COMPARATOR

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

Interventions

Lookware TM DEVICE

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

Lookware TM Control Module DEVICE

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.

Lookware TM Control Module

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• BioStream Technologies, LLC: lead

Study Sites (11)

Milestones Behavioral Services

Orange, Connecticut, 06477, United States

Location

Els for Autism Foundation

Jupiter, Florida, 33458, United States

Location

Positive Behavior Supports Corporation

Melbourne, Florida, 32901, United States

Location

Positive Behavior Supports Corporation

Miami, Florida, 33173, United States

Location

Positive Behavior Supports Corporation

West Palm Beach, Florida, 33409, United States

Location

Nashoba Learning Group, Inc.

Bedford, Massachusetts, 01730, United States

Location

Y.A.L.E. School

Cherry Hill, New Jersey, 08002, United States

Location

Connect Plus Therapy, Inc.

Cherry Hill, New Jersey, 08003, United States

Location

Partners in Learning, Inc.

Clementon, New Jersey, 08021, United States

Location

Mary E. Keefe

Point Pleasant Beach, New Jersey, 08742, United States

Location

The Pathway School

Jeffersonville, Pennsylvania, 19403, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Michael Farber
• Organization: BioStream Technologies, LLC

farberm@biostreamtech.com

856-222-1122

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 14, 2018
• Study Start: August 25, 2018
• Primary Completion: February 19, 2020
• Study Completion: February 19, 2020
• Last Updated: July 15, 2022
• Results First Posted: July 15, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)