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Computer-based Social Skills Training for Autism Spectrum Disorder

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ClinicalTrials.gov Identifier: NCT03672344
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
BioStream Technologies, LLC

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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 : August 16, 2019
Estimated Study Completion Date : August 16, 2019

Resource links provided by the National Library of Medicine


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




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.



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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 75 (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. The parent who completes the questionnaires needs to be proficient in English.
  7. Has successfully played a video game using a Microsoft Xbox game controller, Sony PlayStation game controller, or other comparable game controller.
  8. Parental/guardian permission (informed consent) and if appropriate, child assent.
  9. Wi-Fi internet connection at subject's home/school 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672344


Locations
United States, New Jersey
Mary Elizabeth Keefe Recruiting
Point Pleasant Beach, New Jersey, United States, 08742
Contact: Mary E Keefe, MS    732-245-8568    bethkeefe3@gmail.com   
Sponsors and Collaborators
BioStream Technologies, LLC

Responsible Party: BioStream Technologies, LLC
ClinicalTrials.gov Identifier: NCT03672344     History of Changes
Other Study ID Numbers: 08012018A
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
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:
Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders