Trial Outcomes & Findings for Computer-based Social Skills Training for Autism Spectrum Disorder (NCT NCT03672344)

Last Updated: 2022-07-15

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

6 Weeks

Results posted on

2022-07-15

Participant Flow

No individuals who were enrolled in the study were subsequently excluded from the study.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	25	29
Overall Study COMPLETED	25	29
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lookware TM n=25 Participants 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 n=29 Participants Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.	Total n=54 Participants Total of all reporting groups
Age, Continuous	7.88 years STANDARD_DEVIATION 2.37 • n=25 Participants	9.14 years STANDARD_DEVIATION 3.11 • n=29 Participants	8.56 years STANDARD_DEVIATION 2.84 • n=54 Participants
Sex: Female, Male Female	1 Participants n=25 Participants	6 Participants n=29 Participants	7 Participants n=54 Participants
Sex: Female, Male Male	24 Participants n=25 Participants	23 Participants n=29 Participants	47 Participants n=54 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	25 participants n=25 Participants	29 participants n=29 Participants	54 participants n=54 Participants
Ekman 60 Faces Test	30.84 units on a scale STANDARD_DEVIATION 10.9 • n=25 Participants	31.34 units on a scale STANDARD_DEVIATION 12.94 • n=29 Participants	31.11 units on a scale STANDARD_DEVIATION 11.93 • n=54 Participants
Social Responsiveness Scale	103.28 units on a scale STANDARD_DEVIATION 28.25 • n=25 Participants	108.69 units on a scale STANDARD_DEVIATION 20.92 • n=29 Participants	106.04 units on a scale STANDARD_DEVIATION 24.68 • n=54 Participants
Childhood Joint Attention Rating Scale	28.09 units on a scale STANDARD_DEVIATION 10.42 • n=25 Participants	30.28 units on a scale STANDARD_DEVIATION 5.93 • n=29 Participants	29.23 units on a scale STANDARD_DEVIATION 8.37 • n=54 Participants
Peabody Picture Vocabulary Test	87.5 units on a scale STANDARD_DEVIATION 15.41 • n=25 Participants	86.33 units on a scale STANDARD_DEVIATION 19.30 • n=29 Participants	86.88 units on a scale STANDARD_DEVIATION 17.42 • n=54 Participants

PRIMARY outcome

Timeframe: 6 Weeks

Outcome measures

Outcome measures
Measure	Lookware TM n=25 Participants 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 n=29 Participants Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Ekman-60 Faces Test	38.56 score on a scale Standard Deviation 12.66	32.03 score on a scale Standard Deviation 13.16

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lookware TM n=25 Participants 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 n=26 Participants Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Social Responsiveness Scale	90.44 score on a scale Standard Deviation 19.93	96.38 score on a scale Standard Deviation 20.11

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Lookware TM n=24 Participants 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 n=26 Participants Lookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises.
Childhood Joint Attention Rating Scale	27.17 score on a scale Standard Deviation 8.05	28.62 score on a scale Standard Deviation 7.7

Adverse Events

Lookware TM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lookware TM Control Module

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Farber

BioStream Technologies, LLC

Phone: 856-222-1122

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research sites that employed the PIs agreed not to disclose the trial results without the sponsor's prior written consent.
Publication restrictions are in place

Restriction type: OTHER