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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lookware TM | Active Comparator | Lookware TM computer-based video game that requires the subject to engage in social skills related exercises during simulated social interactions with game characters. |
|
| Lookware TM Control Module | Placebo Comparator | Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lookware TM | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Weeks |
| 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. | 6 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Milestones Behavioral Services | Orange | Connecticut | 06477 | United States | ||
| Els for Autism Foundation |
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No individuals who were enrolled in the study were subsequently excluded from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Lookware TM Control Module |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 7, 2019 |
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|
| Lookware TM Control Module | Device | 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. |
|
| Jupiter |
| Florida |
| 33458 |
| United States |
| Positive Behavior Supports Corporation | Melbourne | Florida | 32901 | United States |
| Positive Behavior Supports Corporation | Miami | Florida | 33173 | United States |
| Positive Behavior Supports Corporation | West Palm Beach | Florida | 33409 | United States |
| Nashoba Learning Group, Inc. | Bedford | Massachusetts | 01730 | United States |
| Y.A.L.E. School | Cherry Hill | New Jersey | 08002 | United States |
| Connect Plus Therapy, Inc. | Cherry Hill | New Jersey | 08003 | United States |
| Partners in Learning, Inc. | Clementon | New Jersey | 08021 | United States |
| Mary E. Keefe | Point Pleasant Beach | New Jersey | 08742 | United States |
| The Pathway School | Jeffersonville | Pennsylvania | 19403 | United States |
Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Social Responsiveness Scale | The Social Responsiveness Scale identifies social impairment in children with ASD. There are five subscales, 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. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| 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 mean worse joint attention. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Peabody Picture Vocabulary Test | The Peabody Picture Vocabulary Test assesses receptive vocabulary. The measure consists of 228 test items, each consisting of four full-color pictures as response options on a page. For each item, the examiner says a word, and the participant responds by selecting the picture that best illustrates that word's meaning. Raw scores are then summed and reported with a population mean of 100 and standard deviation of 15, with a possible range of 20 to 160. In this study, we calculated age-based standard scores, with higher scores indicating better receptive vocabulary. | Mean | Standard Deviation | units on a scale |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Weeks |
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| 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. | Missing data were not imputed for the Social Responsiveness Scale so the analysis sample for these measures differs from the other primary outcome measure. | Posted | Mean | Standard Deviation | score on a scale | 6 Weeks |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 6 Weeks |
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Through study completion, which was approximately 6 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG001 | 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. | 0 | 29 | 0 | 29 | 0 | 29 |
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Research sites that employed the PIs agreed not to disclose the trial results without the sponsor's prior written consent.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Farber | BioStream Technologies, LLC | 856-222-1122 | farberm@biostreamtech.com |
| Apr 26, 2022 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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