Computer-based Social Skills Training for Autism Spectrum Disorder

• Sponsor: BioStream Technologies, LLC (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03672344
• Collaborator: (none)
• Enrollment: 54
• Locations: 11
• Arms: 2
• Actual Duration (Months): 17.8
• Patients Per Site: 4.9
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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: Lookware TM; Device: Lookware TM Control Module	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 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: Aug 25, 2018
• Actual Primary Completion Date: Feb 19, 2020
• Actual Study Completion Date: Feb 19, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: Lookware 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.
Placebo Comparator: 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.	Device: 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. The game is delivered through a laptop computer, eye tracker, and game controller.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Milestones Behavioral Services	Orange	Connecticut	United States	06477
2	Els for Autism Foundation	Jupiter	Florida	United States	33458
3	Positive Behavior Supports Corporation	Melbourne	Florida	United States	32901
4	Positive Behavior Supports Corporation	Miami	Florida	United States	33173
5	Positive Behavior Supports Corporation	West Palm Beach	Florida	United States	33409
6	Nashoba Learning Group, Inc.	Bedford	Massachusetts	United States	01730
7	Y.A.L.E. School	Cherry Hill	New Jersey	United States	08002
8	Connect Plus Therapy, Inc.	Cherry Hill	New Jersey	United States	08003
9	Partners in Learning, Inc.	Clementon	New Jersey	United States	08021
10	Mary E. Keefe	Point Pleasant Beach	New Jersey	United States	08742
11	The Pathway School	Jeffersonville	Pennsylvania	United States	19403

Sponsors and Collaborators

• BioStream Technologies, LLC

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 7, 2019

More Information

Publications

None provided.

• Responsible Party: BioStream Technologies, LLC
• ClinicalTrials.gov Identifier: NCT03672344
• Other Study ID Numbers: 08012018A
• First Posted: Sep 14, 2018
• Last Update Posted: Jul 15, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive

Study Results

Participant Flow

Pre-assignment Detail	No individuals who were enrolled in the study were subsequently excluded from the study.

Arm/Group Title	Lookware TM	Lookware TM Control Module
Arm/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.	Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Period Title: Overall Study
STARTED	25	29
COMPLETED	25	29
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Lookware TM	Lookware TM Control Module	Total
Arm/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.	Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.	Total of all reporting groups
Overall Participants	25	29	54
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	7.88 (2.37)	9.14 (3.11)	8.56 (2.84)
Sex: Female, Male (Count of Participants)
Female	1 4%	6 20.7%	7 13%
Male	24 96%	23 79.3%	47 87%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	25 100%	29 100%	54 100%
Ekman 60 Faces Test (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	30.84 (10.9)	31.34 (12.94)	31.11 (11.93)
Social Responsiveness Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	103.28 (28.25)	108.69 (20.92)	106.04 (24.68)
Childhood Joint Attention Rating Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	28.09 (10.42)	30.28 (5.93)	29.23 (8.37)
Peabody Picture Vocabulary Test (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	87.5 (15.41)	86.33 (19.30)	86.88 (17.42)

Outcome Measures

1. Primary Outcome

Title	Ekman-60 Faces Test
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lookware TM	Lookware TM Control Module
Arm/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.	Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Measure Participants	25	29
Mean (Standard Deviation) [score on a scale]	38.56 (12.66)	32.03 (13.16)

2. Primary Outcome

Title	Social Responsiveness Scale
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lookware TM	Lookware TM Control Module
Arm/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.	Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Measure Participants	25	26
Mean (Standard Deviation) [score on a scale]	90.44 (19.93)	96.38 (20.11)

3. Secondary Outcome

Title	Childhood Joint Attention Rating Scale
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Lookware TM	Lookware TM Control Module
Arm/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.	Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Measure Participants	24	26
Mean (Standard Deviation) [score on a scale]	27.17 (8.05)	28.62 (7.7)

Adverse Events

Time Frame	Through study completion, which was approximately 6 weeks.
Arm/Group Title	Lookware TM		Lookware TM Control Module
Arm/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.		Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
All Cause Mortality
	Lookware TM		Lookware TM Control Module
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/29 (0%)
Serious Adverse Events
	Lookware TM		Lookware TM Control Module
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Lookware TM		Lookware TM Control Module
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/29 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Research sites that employed the PIs agreed not to disclose the trial results without the sponsor's prior written consent.