Superpower Glass Project: A Mobile At-home Intervention for Children With Autism
Phase: NA
Conditions: Autism Spectrum Disorder
Sponsor: Dennis Paul Wall

Randomized Controlled Trial for Superpower Glass 
Extended Protocol for IRB-34059 
ClinicalTrials.gov Identifier: NCT03569176 
Dr. Dennis P. Wall 
Stanford University School of Medicine
Updataed Protocol as of 5/07/2018 

1. Purpose
a)
In layperson's language state the purpose of the study in 3-5 sentences.
The purpose of this research is to study the effects of a novel combined software-hardware 
device built onto commercially available Google Glass technology that provides an 
automated emotion expression recognition system and face tracker to determine the 
effects of providing social cues to individuals with a diagnosis of ASD. This novel device 
will use a camera, microphone, and head motion tracker that will record 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.
b)
State what the Investigator(s) hope to learn from the study. Include an assessment of the 
importance of this new knowledge.
Investigators hope to learn the effects of this novel software-hardware device in terms of 
providing social cues to individuals with ASD. Refining and evaluating this system has 
implications to not only help aid behavioral interventions with individuals with ASD, but it 
also has broader implications on new forms of human-computer and human-human 
interaction. The system's ability to provide continuous behavioral therapy outside of clinical 
settings will enable dramatically faster gains in social acuity that may, within a limited and 
self-directed period of time, encourage the child to engage in more advanced social 
settings on his/her own.
c)
Explain why human subjects must be used for this project.
Human subjects must be used for this project because the purpose of the study is to 
determine the efficacy of this novel device in social interactions for individuals with ASD. 
There are no suitable animal models for facial emotion recognition in ASD, nor are there 
comparable behavioral therapies for animals, and therefore, human subjects must be 
used.

2. Study Procedures:  
 
Participants: Participants will be ages 6-12 years old. We anticipate recruiting up to 80 ASD 
participants. We will also be recruiting family members and friends of participants to consent to 
participate as "non-participants." The research staff will obtain informed consent before any 
study procedures begin. Consent and assent will be obtained either electronically or in-person. 
 
For n=50 participants, we will run a cross-over design study where 25 participants will 
randomly be assigned to group one and continue treatment as usual (control), or group two 
and continue treatment as usual plus study procedures (treatment). For these 50 participants, 
they must receive ABA therapy in the home at least 2xs/week. We will try to understand the 
efficacy of the device in comparison to ABA therapy.  
The procedures for the "treatment" group are as follow:  
1/ complete screening questionnaires and phone screen  
2/ come in for onboarding session (as described above) and take device  
home to use for 6 weeks. They will use the device at least 4xs/week  
for 20 minute sessions with either their parents or ABA therapist.  
They will have phone calls with study managers to see how usage of the device at home is 
going.  
3/ come in for conclusion (as described above) and return device  
4/ come in 6 weeks later for follow up (as described above)  
During onboarding, conclusion, and follow-up, we will also conduct unstructured interviews to 
get feedback from research participants. At the end of the 12 week "treatment group" period 
and they complete the follow up, a $50 Amazon gift card is provided as compensation for 
participation in the study.  
The procedures for the "control" group are as follow:  
1/ complete screening questionnaires and phone screen  
2/ come in for onboarding session (as described above)  
3/ come in for an appointment (appointment 1) 6 weeks after onboarding and conduct 
evaluations again. Participants will now take device home to use for 6 weeks. They will use the 
device at least 4xs/week for 20 minute sessions with either their parents or ABA therapist. 
They will have phone calls with study managers to see how usage of the device at home is 
going.  
4/ come in for conclusion (as described above) and return device  
5/ come in 6 weeks later for follow up (as described above)  
During onboarding, appointment 1, conclusion, and follow-up, we will also conduct 

unstructured interviews to get feedback from research participants. At the end of the 18 week 
"control group" period and they complete the follow up, we will provide to them a $50 Amazon 
gift card. 
Screening Questionnaire: We will send around a link to a redcap survey for all recruited 
participants from the recruitment website and with other recruitment efforts. We will ask 
interested participants to fill out the Screening Questionnaire. Our goal will be to determine 
eligibility based on location (needs to be local to Stanford), still interested in participating, has 
a child that meets our eligibility criteria, and a brief overview of the child. Eligible families will 
be contacted via email or phone to set up scheduling for in-lab study sessions. Parents will be 
asked to fill out these questionnaires no more than 4 times each (Baseline, at the end of the 
intervention, and at 6-weeks follow-up). 
Standardized Behavioral and Clinical Characterization Scales, Checklists, and Measures: 
Clinical Phenotyping Measures Parents: The Social Responsiveness Scale (SRS-2), The 
Vineland Adaptive Behavior Scale (VABS-2), Social Communication Questionnaire (SCQ), and 
Child Behavior Checklist (CBCL). 
Child: Participants will also undergo the Abbreviated Battery IQ (ABIQ), which consists of two 
subsections of the Stanford-Binet, 5th Edition Intelligence Test. We will also collect the 
NEPSY-II Affect Recognition and Emotion Guessing Game, as well as Overall Social 
Interaction (Brief Observation of Social Communication Change, BOSCC). At one of the in-
person appointments, we will have participants and consented/assented family members read 
aloud a script (see section 16) into a microphone to collect audio data to later analyze to help 
with expression recognition software. 
Study Procedures: 
First session (Onboarding): Subjects and family members will be asked to come to the Wall 
Lab at 1265 Welch Rd to obtain written or electronic consent. Individuals will meet the study 
team, will discuss expectations with study manager, discuss how to use the device units, and 
go over scheduling. Cognitive testing will be conducted in a private assessment where 
participants will complete the ABIQ. The child/family will then take the Glass home for the 
duration of the study or we will mail the units home. 
Glass at Home: Each participating family will have the Glass units for several weeks during 
which time the child will use the unit in their own natural environment at home on a daily basis. 
We will engage on a biweekly to weekly basis (will modify timing if and when necessary) to 
receive and react to feedback, and then have two-four monthly “in-lab” assessments to monitor 
improvement of the participant. These checkins can be in person or via a video conference. 
During the sessions, we will conduct semi-structured and structured interviews to obtain 

information about face-gaze, emotion recognition capabilities, and feedback on how the at 
home sessions are going. We will also collect additional information from the families and 
participants that they are willing to provide about their experience. 
Conclusion: Individuals will come to Stanford to return the units and provide feedback on their 
experience. They can also mail back their units and have the conclusion session via video 
conferencing. We will have structured and structured interviews. 
Follow up: Study team will connect with participants and families to administer the 
questionnaires and discuss feedback post study. 
We will also have a control population for the study. They will not receive Google Glasses or 
Android phones. They will only be used as a control group to validate the outcome measures 
for emotion recognition. A blind study member will evaluate the control population as well as 
the population with ASD on their ability to recognize 
facial emotions. They will do this by acting out 8 emotions, 5xs each (Happy, sad, angry, 
scared, surprised, disgusted, calm, and contempt/meh). We will conduct the emotion 
recognition evaluation at the checkins for our ASD population and scheduled checkins for our 
control group. A study team member will meet with the control group, 
possibly at a social skills class, school, or in their homes, to remain blind to which cohort they 
are collecting this data from. This emotion recognition component takes about 5 minutes. 
We will partner with Autism Comprehensive Educational Services (ACES) who offer a variety 
of behavioral and educational services for individuals impacted with autism or other 
developmental disabilities in the home, school, community, and at accredited sites throughout 
the United States. Our main contact will be [redacted], Ph.D., BCBA-D, Chief Clinical Officer, 
and she will manage the staff from ACES. ACES will help with participant selection: 
ACES will help recruit some of our participants. They will screen for participants for IRB 34059 
from the population for which they serve. ACES will define and assist in the screening process 
for eligible participants from said population. They will screen for participants based off of 
recruitment criteria explained in IRB 34059. Upon selection of participants, ACES will provide 
contact information to Autism Glass, Wall Lab for which Autism Glass, Wall Lab will officially 
enroll selected participants into IRB 34059. 
3. Statistical Analysis Plan
This study will follow an intention-to-treat (ITT) analysis, which will include all participants
randomized in the study, regardless of missing data. Our hypothesis is that children
randomized to receive the Superpower Glass intervention will show a significant improvement
on the primary outcome measures, as compared to controls. We will apply a mixed effects

model analysis to assess change from baseline (week 0) to post-test 1 (week 6) in the primary 
outcome measures.  
Primary Outcome Measures: 
1. Vineland Adaptive Behavior Scales, 2nd Edition (VABS-II), Socialization subscale
2. Social Responsiveness Scale 2 (SRS-2)
3. NEPSY-II, Affect Recognition subscale
4. Emotion Guessing Game (EGG) scores
Secondary Outcome Measures: 
1. Brief Observation of Social Communication Change (BOSCC)
2. Vineland Adaptive Behavior Scales, 2nd edition (VABS-II) Full Scale
3. Child Behavior Checklist (CBCL)
Other measures collected: 
1. Stanford-Binet Intelligence Scales, Abbreviated Battery, Fifth Edition (ABIQ)
2. Mobilized Machine Learning Autism Risk Assessment (MARA)
3. Social Communication Questionnaire (SCQ)
We will also perform sensitivity analyses to examine the extent to which outcome measures 
are correlated to the child’s age and autism severity, as well as by usage factors, such as 
variation in compliance with recommended dosage and missing data from families lost to 
follow-up. We will use the same approach to assess differences on secondary outcomes 
between groups using the same mixed effects model analysis. Lastly, we will perform a six-
week follow-up analysis on the treatment group to test if a return to baseline occurred.