Computer-based Social Skills Training for Autism Spectrum Disorder

BioStream Technologies

Status: Completed

Conditions: Autism Spectrum Disorder

Treatments: Device: Lookware TM Control Module; Device: Lookware TM

Study type: Interventional

Funder types: Industry

Identifiers

NCT03672344

08012018A

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 4 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Lookware TM

Active Comparator group

Description:

Lookware TM computer-based video game that requires the subject to engage in social skills related exercises during simulated social interactions with game characters.

Treatment:

Device: Lookware TM

Lookware TM Control Module

Placebo Comparator group

Description:

Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.

Treatment:

Device: Lookware TM Control Module