Computer-based Social Skills Training for Autism Spectrum Disorder

• ClinicalTrials.gov Identifier: NCT03672344
• Recruitment Status: Active, not recruiting
• First Posted: September 14, 2018
• Last Update Posted: July 20, 2021
• Sponsor: BioStream Technologies, LLC
• Information provided by (Responsible Party): BioStream Technologies, LLC

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.

Condition or disease	Intervention/treatment	Phase
Autism Spectrum Disorder	Device: BioStream Training; Device: Alternative Game	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Computer-based Social Skills Training for Autism Spectrum Disorder
• Actual Study Start Date: August 25, 2018
• Estimated Primary Completion Date: January 31, 2022
• Estimated Study Completion Date: January 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: BioStream Training	Device: BioStream Training; Gaze-controlled video game that leverages ABA principles of learning to target social skills deficits in children with autism spectrum disorder.
Placebo Comparator: Alternative Game	Device: Alternative Game; Alternative Control Group Game

Outcome Measures

Primary Outcome Measures :

1. Intervention's Efficacy in Improving Eye Contact - Primary Outcome Measure 1 [ Time Frame: 8 weeks ]
   The mean change from baseline score based on post-final game play session assessment compared to the alternate game group with respect to subject gaze patterns as measured by video eye tracking assessment using an eye tracking device.
2. Intervention's Efficacy in Improving Eye Contact - Primary Outcome Measure 2 [ Time Frame: 8 Weeks ]
   The mean change from baseline score based on post-final game play session assessment compared to the alternate game group with respect to subject gaze patterns as measured during a dyadic interaction task using a video recording device.
3. Intervention's Efficacy in Improving Emotion Recognition - Primary Outcome Measure 3 [ Time Frame: 8 Weeks ]
   The mean change from baseline score based on post-final game play session assessment compared to the alternate game group on the Ekman 60 Faces Test.
4. Intervention's Efficacy in Improving Attention - Primary Outcome Measure 4 [ Time Frame: 8 Weeks ]
   The mean change from baseline score based on post-final game play session assessment compared to the alternate game group on the Test of Variables of Attention.
5. Intervention's Efficacy in Improving Eye Contact and Emotion Recognition - Primary Outcome Measure 5 [ Time Frame: 8 Weeks ]
   The mean change from baseline score based on post-final game play session assessment compared to the alternate game group on the Social Responsiveness Scale.

Secondary Outcome Measures :

1. Gaze Pattern Based Assessment Capability [ Time Frame: 8 Weeks ]
   To observe changes in subject gaze patterns, as measured by an eye tracking device, during viewing of social videos and during engaging in dyadic interaction task, social skills assessments, after engaging in BioStream Training, including in comparison to an alternate game.
2. Game Performance Based Assessment Capability [ Time Frame: 8 Weeks ]
   To observe possible correlations in changes in social skills assessments with changes in subject game play performance by comparing measurements taken using an eye tracking device, during viewing of social videos and during engaging in dyadic interaction task, the results of the Ekman 60 Faces Test, the results of Test of Variables of Attention, the results of the Social Responsiveness Scale, and the results of the Childhood Joint Attention Rating Scale, and comparing those measurements against performance of in-game tasks during simulated social interactions.
3. Intervention's Efficacy in Improving Joint Attention [ Time Frame: 8 Weeks ]
   The mean change from baseline score based on post-final game play session assessment compared to the alternate game group on the Childhood Joint Attention Rating Scale.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Connecticut

Milestones Behavioral Services

Orange, Connecticut, United States, 06477

United States, Florida

Els for Autism Foundation

Jupiter, Florida, United States, 33458

Positive Behavior Supports Corporation

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

United States, Massachusetts

Nashoba Learning Group, Inc.

Bedford, Massachusetts, United States, 01730

United States, New Jersey

Y.A.L.E. School

Cherry Hill, New Jersey, United States, 08002

Connect Plus Therapy, Inc.

Cherry Hill, New Jersey, United States, 08003

Partners in Learning, Inc.

Clementon, New Jersey, United States, 08021

Mary E. Keefe

Point Pleasant Beach, New Jersey, United States, 08742

United States, Pennsylvania

The Pathway School

Jeffersonville, Pennsylvania, United States, 19403

Sponsors and Collaborators

BioStream Technologies, LLC

More Information

• Responsible Party: BioStream Technologies, LLC
• ClinicalTrials.gov Identifier: NCT03672344
• Other Study ID Numbers: 08012018A
• First Posted: September 14, 2018
• Last Update Posted: July 20, 2021
• Last Verified: July 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders