Autism Spectrum Disorder
Conditions
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.
Interventions
DEVICELookware TM
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.
DEVICELookware TM Control Module
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.
Sponsors
BioStream Technologies, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ekman-60 Faces Test | 6 Weeks | 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. |
| Social Responsiveness Scale | 6 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Childhood Joint Attention Rating Scale | 6 Weeks | The Childhood Joint Attention Rating Scale is used to assess joint attention in children with autism spectrum disorder. In this study, we used the asocial subscale, which consists of 14 items on a scale from 0 to 4. Scores were then summed, with a possible range from 0 to 56, and higher scores meant worse joint attention. |
Countries
United States
Participant flow
Pre-assignment details
No individuals who were enrolled in the study were subsequently excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| Lookware TM Lookware TM computer-based video game that requires the subject to engage in social skills related exercises during simulated social interactions with game characters. | 25 |
| Lookware TM Control Module Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises. | 29 |
| Total | 54 |
Baseline characteristics
| Characteristic | Lookware TM Control Module | Total | Lookware TM |
|---|---|---|---|
| Age, Continuous | 9.14 years STANDARD_DEVIATION 3.11 | 8.56 years STANDARD_DEVIATION 2.84 | 7.88 years STANDARD_DEVIATION 2.37 |
| Childhood Joint Attention Rating Scale | 30.28 units on a scale STANDARD_DEVIATION 5.93 | 29.23 units on a scale STANDARD_DEVIATION 8.37 | 28.09 units on a scale STANDARD_DEVIATION 10.42 |
| Ekman 60 Faces Test | 31.34 units on a scale STANDARD_DEVIATION 12.94 | 31.11 units on a scale STANDARD_DEVIATION 11.93 | 30.84 units on a scale STANDARD_DEVIATION 10.9 |
| Peabody Picture Vocabulary Test | 86.33 units on a scale STANDARD_DEVIATION 19.3 | 86.88 units on a scale STANDARD_DEVIATION 17.42 | 87.5 units on a scale STANDARD_DEVIATION 15.41 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 29 participants | 54 participants | 25 participants |
| Sex: Female, Male Female | 6 Participants | 7 Participants | 1 Participants |
| Sex: Female, Male Male | 23 Participants | 47 Participants | 24 Participants |
| Social Responsiveness Scale | 108.69 units on a scale STANDARD_DEVIATION 20.92 | 106.04 units on a scale STANDARD_DEVIATION 24.68 | 103.28 units on a scale STANDARD_DEVIATION 28.25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 29 |
| other Total, other adverse events | 0 / 25 | 0 / 29 |
| serious Total, serious adverse events | 0 / 25 | 0 / 29 |
Outcome results
Primary
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.
Time frame: 6 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lookware TM | Ekman-60 Faces Test | 38.56 score on a scale | Standard Deviation 12.66 |
| Lookware TM Control Module | Ekman-60 Faces Test | 32.03 score on a scale | Standard Deviation 13.16 |
Primary
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.
Time frame: 6 Weeks
Population: Missing data were not imputed for the Social Responsiveness Scale so the analysis sample for these measures differs from the other primary outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lookware TM | Social Responsiveness Scale | 90.44 score on a scale | Standard Deviation 19.93 |
| Lookware TM Control Module | Social Responsiveness Scale | 96.38 score on a scale | Standard Deviation 20.11 |
Secondary
Childhood Joint Attention Rating Scale
The Childhood Joint Attention Rating Scale is used to assess joint attention in children with autism spectrum disorder. In this study, we used the asocial subscale, which consists of 14 items on a scale from 0 to 4. Scores were then summed, with a possible range from 0 to 56, and higher scores meant worse joint attention.
Time frame: 6 Weeks
Population: Missing data were not imputed for the Childhood Joint Attention Rating Scale, so the analysis sample for these measures differs from the Ekman-60 Faces Test primary outcome measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lookware TM | Childhood Joint Attention Rating Scale | 27.17 score on a scale | Standard Deviation 8.05 |
| Lookware TM Control Module | Childhood Joint Attention Rating Scale | 28.62 score on a scale | Standard Deviation 7.7 |