Autism Spectrum DisorderNCT03672344
Computer-based Social Skills Training for Autism Spectrum Disorder
A study testing Lookware TM in people with Autism Spectrum Disorder, run by BioStream Technologies, LLC at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Lookware TM
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 11 sitesUnited States
- Study dates
- 25 Aug 2018to 19 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ages 4-14.
- Meets diagnostic criteria for ASD.
- 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)).
- Parent reports difficulty with at least one of two social skills (via modified questions from the Social Responsiveness Scale)
- English as the child's primary/first language (key measures used in the study do not have alternate language versions).
- Attains a score equal to or less than 75% correct on the Ekman 60 Faces Test
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- The parent who completes the questionnaires needs to be proficient in English.
- Has successfully played a video game using a Microsoft Xbox game controller, Sony PlayStation game controller, or other comparable game controller.
- Parental/guardian permission (informed consent) and if appropriate, child assent.
- Wi-Fi internet connection at subject's home/school/therapy center/research organization available for use by study laptop computer.
Who cannot join
- History of seizures.
- History of traumatic brain injury or other significant medical or neurological abnormality affecting motor or higher cortical functioning.
- Certain visual, auditory, DSM 5, or conduct disorders (see below).
- A visual disorder that cannot be corrected through the use of corrective lenses to a level of 20-40 in both eyes.
- Use of corrective visual lenses that would significantly impede the valid collection of visual attention and gaze pattern data during dyadic interaction tasks.
- Auditory impairment (that cannot be corrected by a hearing aid) that would significantly impede the valid collection of test measures.
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- 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.
- 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.
- History of one or more psychiatric hospitalizations.
- Presence of significant symptoms of a conduct disorder.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Nashoba Learning Group, Inc.
Bedford, Massachusetts, 01730
Y.A.L.E. School
Cherry Hill, New Jersey, 08002
Connect Plus Therapy, Inc.
Cherry Hill, New Jersey, 08003
Partners in Learning, Inc.
Clementon, New Jersey, 08021
The Pathway School
Jeffersonville, Pennsylvania, 19403
Els for Autism Foundation
Jupiter, Florida, 33458
Positive Behavior Supports Corporation
Melbourne, Florida, 32901
Positive Behavior Supports Corporation
Miami, Florida, 33173
Milestones Behavioral Services
Orange, Connecticut, 06477
Mary E. Keefe
Point Pleasant Beach, New Jersey, 08742
Positive Behavior Supports Corporation
West Palm Beach, Florida, 33409
About this study
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Lookware TM, Lookware TM Control Module
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lookware TMDevice
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.
Lookware TM Control ModuleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lookware TM |
| 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. Receives: Device: Lookware TM Control Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 Weeks
Secondary outcomes (1)
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.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start25 Aug 2018
- Primary completion19 Feb 2020
- Study completion19 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioStream Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672344
- Sponsor's protocol ID
- 08012018A
- Status last verified
- Jun 2022
- First submitted
- 11 Sep 2018
- Last updated
- 15 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Social Skills Training for Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT03672344
- Acronym / sponsor ID
- 08012018A
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- BioStream Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 19 Feb 2020 (actual)
- Study completion
- 19 Feb 2020 (actual)
- First posted
- 14 Sep 2018 (actual)
- Results
- Posted 15 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lookware TM | Active comparator | Device: Lookware TMLookware 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 | Device: Lookware TM Control ModuleLookware TM Control Module is a version of the Lookware TM computer-based video game that excludes the social skills related exercises. |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Ages 4-14.
- Meets diagnostic criteria for ASD.
- 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)).
- Parent reports difficulty with at least one of two social skills (via modified questions from the Social Responsiveness Scale)
- English as the child's primary/first language (key measures used in the study do not have alternate language versions).
Key exclusion criteria (10 listed)
- History of seizures.
- History of traumatic brain injury or other significant medical or neurological abnormality affecting motor or higher cortical functioning.
- Certain visual, auditory, DSM 5, or conduct disorders (see below).
- A visual disorder that cannot be corrected through the use of corrective lenses to a level of 20-40 in both eyes.
- Use of corrective visual lenses that would significantly impede the valid collection of visual attention and gaze pattern data during dyadic interaction tasks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lookware TMLookware 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. | Device | Lookware TM |
| Lookware TM Control ModuleLookware 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. | Device | Lookware TM Control Module |
Primary outcome
Ekman-60 Faces Test
Time frame: 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
Time frame: 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.
1 secondary outcome
Childhood Joint Attention Rating Scale
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lookware TM in people with Autism Spectrum Disorder, run by BioStream Technologies, LLC at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ekman-60 Faces Test (time frame: 6 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.