Autism Spectrum DisorderNCT03569176
Examining the Efficacy of a Mobile Therapy for Children With Autism Spectrum Disorder
A study testing Autism Glass in people with Autism Spectrum Disorder, run by Dennis Paul Wall.
Trial summary
The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Autism Glass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2016to 15 Apr 2018
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the child has been diagnosed professionally with ASD
- the child is currently receiving ABA therapy at least twice per week at home.
- The child's family is willing to drive to Stanford University for up to 4 study appointments.
Who cannot join
- The child scores less than 15 on the Social Communication Questionnaire
- The child's family does not speak English
About this study
Official title: Superpower Glass Project: A Mobile At-home Intervention for Children With Autism
The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that the system's ability to provide continuous behavioral therapy during social interactions will enable faster gains in social skills.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Autism Glass
- Keywords
- mobile health, autism, ASD, mobile therapy, digital, wearable computing, technology
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autism GlassDevice
The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
| Study group | Role | What they receive |
|---|---|---|
| Autism Glass Intervention | Experimental | Participants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. Receives: Device: Autism Glass |
| Crossover Control for Autism Glass | Other | Participants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). Receives: Device: Autism Glass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.
Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Socialization subscale will be conducted at the university by a trained research team member. Scores from the socialization domain of the VABS-II reflects one's functioning in social situations. The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores (mean: 100 sd: 15) for each domain and for the composite adaptive behavior score.The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.
Measured: Baseline (week 0), Week 6
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6
The SRS-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severity. Social Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
Measured: Baseline (week 0), Week 6
Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6
The Emotion Guessing Game is a novel test created for purposes of this study to evaluate the child's ability to correctly label emotions expressed by an examiner in real time. EGG is a pre-set list of 8 emotions, listed 5 times each (Happy, Sad, Angry, Afraid, Surprised, Calm, Disgust, and "Meh"/contempt). During the quick 40-question evaluation, the research coordinator first lists the various emotion choices to the child before beginning the evaluation. Then, the examiner acts out each emotion listed, in order, and waits for a guess from the child, who labels the emotion. The EGG is scored by summing the number of correct responses from the child, higher scores indicated better emotion recognition, where scores can range from 0 to 40.
Measured: Baseline (week 0), Week 6
Secondary outcomes (4)
Change in ASD Symptoms as Measured by Brief Observation of Social Communication Change (BOSCC) From Baseline to Week 6
The Brief Observation of Social Communication Change (BOSCC) is designed to measure change in core symptoms of children with autism. It aims to capture change in social communication, interaction, and eye contact. The BOSCC is a play based assessment that consists of two boxes filled with specific toys and takes about 12 minutes to complete.
Measured: Baseline (week 0), week 6
Change in Adaptive Social and Personal Skills as Measured by Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) Full Scale From Baseline to Week 6.
The VABS-II is a robust and comprehensive measure of personal and social skills needed in everyday living. The VABS-II covers a child's conceptual, social, and practical skills and can assess children from birth to 90 years. The parent can complete the entire questionnaire in about 20-30 minutes. The raw score in each domain and total raw score are converted to an age-equivalent score. The domain scores are also expressed as standard scores with a mean of 100 and standard deviation of 15. The range for each subscale is from 20 to 140. The subscales are summed to compute a total score, ranging from 80 to 560. The higher the scores are, the better adaptive functioning the children achieve.
Measured: Baseline (week 0), week 6
Change in Child's Emotional, Behavioral, and Social Problems From Baseline (Week 0) to Week 6 as Measured by Child Behavior Checklist (CBCL) Total Score.
The CBCL is a caregiver-directed report that identifies emotional, behavioral, and social problems in children. The patient is rated on 113 items scored on a 3-point Likert-type scale. CBCL total score consists of eight empirically-based syndrome subscales. The total competence score is reported, range: 0-100, where higher scores suggests the more severe symptoms.
Measured: Baseline (week 0), Week 6
Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6
The NEPSY-II Affect Recognition subdomain assesses a child's social perception of facial affect recognition. It is designed to assess a child's ability to recognize 6 emotions (happy, sad, angry, fear, disgust, and neutral) from colored photographs of children's faces in four different tasks. Scores range from 1 (well below expected level) to 19 (well above expected level), and have a mean of 10 [standard deviation= 3] that is based on a U.S. normative sample.
Measured: Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Nov 2016
- Primary completion11 Apr 2018
- Study completion15 Apr 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dennis Paul Wall
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dennis Paul Wall, Stanford University
- Investigators
- Dennis P Wall, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569176
- Sponsor's protocol ID
- IRB-34059
- Status last verified
- Nov 2024
- First submitted
- 14 Jun 2018
- Last updated
- 20 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Voss C, Schwartz J, Daniels J, Kline A, Haber N, Washington P, Tariq Q, Robinson TN, Desai M, Phillips JM, Feinstein C, Winograd T, Wall DP. Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Pediatr. 2019 May 1;173(5):446-454. doi: 10.1001/jamapediatrics.2019.0285.
PubMed 30907929
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Superpower Glass Project: A Mobile At-home Intervention for Children With Autism
- ClinicalTrials.gov ID
- NCT03569176
- Acronym / sponsor ID
- IRB-34059
- Conditions
- Autism Spectrum Disorder
- Keywords
- mobile health, autism, ASD, mobile therapy, digital, wearable computing, technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Dennis Paul WallUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 11 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Posted 23 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that the system's ability to provide continuous behavioral therapy during social interactions will enable faster gains in social skills.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autism Glass Intervention | Experimental | Device: Autism GlassParticipants in the experimental group will receive the autism glass for 6 weeks once they are assigned to the experimental condition. Participants will be asked to use the glasses at least 3 times a week for 20 minutes sessions in addition to continuing Applied Behavior Analysis (ABA) therapy. |
| Crossover Control for Autism Glass | Other | Device: Autism GlassParticipants randomized to the control arm, will continue treatment as usual (receiving ABA twice a week) while the intervention participants will receive the Autism Glass intervention (while continuing to receive ABA therapy). After 6 weeks, control participants will receive the Autism Glass intervention after which, they will be asked to come in for a second round of follow-up testing following 6 weeks of use (at week 18). |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- the child has been diagnosed professionally with ASD
- the child is currently receiving ABA therapy at least twice per week at home.
- The child's family is willing to drive to Stanford University for up to 4 study appointments.
Key exclusion criteria (2 listed)
- The child scores less than 15 on the Social Communication Questionnaire
- The child's family does not speak English
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 |
|---|---|---|
| Autism GlassThe intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy. | Device | Autism Glass Intervention, Crossover Control for Autism Glass |
Primary outcome
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6.
Time frame: Baseline (week 0), Week 6
Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Socialization subscale will be conducted at the university by a trained research team member. Scores from the socialization domain of the VABS-II reflects one's functioning in social situations. The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores (mean: 100 sd: 15) for each domain and for the composite adaptive behavior score.The socialization subscale is 32 items, where raw scores are converted to IQ-type standard scores--v-scale scores (M=15, SD=3) where scores range from 1 to 24, and factor in age equivalents, growth scale values, and higher scores indicate better adaptive functioning.
Change in Parent Rated Social Responsiveness Scale 2 (SRS-2) From Baseline to Week 6
Time frame: Baseline (week 0), Week 6
The SRS-2 is a 65-item measure where parents rate their child selecting responses on a Likert Scale. This measure will be used to measure and identify social impairment associated with Autism Spectrum Disorder (ASD) and to quantify its severity. Social Responsiveness Scale (SRS) raw scores measure social abilities with lower scores indicating better social skills. (Raw Score Range: 0 - 195 and T-Score Range: 37- above 90).
Change in Emotion Guessing Game (EGG) Scores From Baseline to Week 6
Time frame: Baseline (week 0), Week 6
The Emotion Guessing Game is a novel test created for purposes of this study to evaluate the child's ability to correctly label emotions expressed by an examiner in real time. EGG is a pre-set list of 8 emotions, listed 5 times each (Happy, Sad, Angry, Afraid, Surprised, Calm, Disgust, and "Meh"/contempt). During the quick 40-question evaluation, the research coordinator first lists the various emotion choices to the child before beginning the evaluation. Then, the examiner acts out each emotion listed, in order, and waits for a guess from the child, who labels the emotion. The EGG is scored by summing the number of correct responses from the child, higher scores indicated better emotion recognition, where scores can range from 0 to 40.
4 secondary outcomes
Change in ASD Symptoms as Measured by Brief Observation of Social Communication Change (BOSCC) From Baseline to Week 6
Time frame: Baseline (week 0), week 6
Change in Adaptive Social and Personal Skills as Measured by Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) Full Scale From Baseline to Week 6.
Time frame: Baseline (week 0), week 6
Change in Child's Emotional, Behavioral, and Social Problems From Baseline (Week 0) to Week 6 as Measured by Child Behavior Checklist (CBCL) Total Score.
Time frame: Baseline (week 0), Week 6
Change in NEPSY-II, Affect Recognition Subscale Scores From Baseline to Week 6
Time frame: Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), Week 6 Baseline (week 0), week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30907929Voss C, Schwartz J, Daniels J, Kline A, Haber N, Washington P, Tariq Q, Robinson TN, Desai M, Phillips JM, Feinstein C, Winograd T, Wall DP. Effect of Wearable Digital Intervention for Improving Socialization in Children With Autism Spectrum Disorder: A Randomized Clinical Trial. JAMA Pediatr. 2019 May 1;173(5):446-454. doi: 10.1001/jamapediatrics.2019.0285.
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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.
Dennis P Wall, PhD principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
A study testing Autism Glass in people with Autism Spectrum Disorder, run by Dennis Paul Wall.
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 3 inclusion and 2 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 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 23 Sep 2024). 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?
Change in Socialization Subscale Scores of the Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II) From Baseline to Week 6. (time frame: Baseline (week 0), Week 6). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569176, which also lists 1 linked publication.
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 20 Dec 2024.