Clinical trial NCT03672344: Computer-based Social Skills Training for Autism Spectrum Disorder
Official title: Computer-based Social Skills Training for Autism Spectrum Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: BioStream Technologies, LLC
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 54
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Ekman-60 Faces Test
timeFrame: 6 Weeks
measure: Social Responsiveness Scale
timeFrame: 6 Weeks
Secondary outcomes:
measure: Childhood Joint Attention Rating Scale
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Orange
country: United States
facility: Milestones Behavioral Services
state: Connecticut
city: Jupiter
country: United States
facility: Els for Autism Foundation
state: Florida
city: Melbourne
country: United States
facility: Positive Behavior Supports Corporation
state: Florida
city: Miami
country: United States
facility: Positive Behavior Supports Corporation
state: Florida
city: West Palm Beach
country: United States
facility: Positive Behavior Supports Corporation
state: Florida
city: Bedford
country: United States
facility: Nashoba Learning Group, Inc.
state: Massachusetts
city: Cherry Hill
country: United States
facility: Y.A.L.E. School
state: New Jersey
city: Cherry Hill
country: United States
facility: Connect Plus Therapy, Inc.
state: New Jersey
city: Clementon
country: United States
facility: Partners in Learning, Inc.
state: New Jersey
city: Point Pleasant Beach
country: United States
facility: Mary E. Keefe
state: New Jersey
city: Jeffersonville
country: United States
facility: The Pathway School
state: Pennsylvania
Study officials:
References: