Intervention has been proven effective to improve interpersonal and communication skills
for people with low social awareness or certain neurological conditions such as autism
spectrum disorder. However, the application of this type of trainings is limited due to
the lack of trained clinicians, the difficulties in finding/creating social settings, and
the cost of ongoing treatments, among other factors. In this study, the investigators
hope to elucidate whether autistic individuals will benefit from the translation of
face-to-face interventions delivered by AI application (app) that can be easily accessed
on the phone or computer.
For the last decades, the world has experienced a geometric increase in the number of
individuals diagnosed with autism spectrum disorder, with the CDC reporting that 1 in 31
individuals now being diagnosed with the condition. With such large numbers, individuals
in need of intervention services face long clinical wait times along with a shortage of
trained providers. From this study, the investigators aim to learn whether AI programs
that do not require the labor-intensive face-to-face clinician hours are effective in
improving the social communication of autistic individuals.
The investigators anticipate that in just 4 weeks of short daily (weekdays) practice
sessions with the app, the treatment groups will show improvements in areas that are
generally challenging for this population and adolescents and adults will report more
confidence during social conversation compared to the waitlist control groups. The
investigators are requesting that participants complete a minimal number of intervention
trials, with the option of completing more if desired. Should participants vary in their
improvement based on intervention time, this information should assist with understanding
an optimal level of intervention for effectiveness. The investigators will carefully
document percentage correct for each module, time spent on the module, and improvement.
The investigators will match adult participants who are within 5 years of age.
Adolescents and young children will not be matched but will be divided equally into two
groups. The investigators anticipate no change in the wait list control groups.
The purpose of this study is to examine the efficacy of Artificial Intelligence (AI)
intervention using an application for autistic individuals; therefore, human subjects
need to be used for this project.
The intervention our Artificial Intelligence (AI) app targets has already been developed
and is based on face-to-face research studies. The study will recruit autistic adults,
adolescents, and young children from the community and will assess the effects of using
artificial intelligence to practice social conversation.
Our staff will have a single phone/Zoom contact with potential autistic participants
and/or parents wishing to enroll in the online training intervention to complete a brief
screening before completing informed consent documents electronically through Adobe Sign.
Participants must have a primary diagnosis of autism spectrum disorder to participate.
Adolescent and adult participants must be able to understand and converse in complete
sentences.
Parents of potential adolescent participants and potential participants will complete a
password-protected 10-20 minute phone/Zoom screening (Zoom is safe for PHI) to determine
whether their child/they are eligible for the study.
For adolescents, during the last five minutes of the phone/Zoom screen, research
personnel will invite the adolescent to join in a brief conversation. The researcher's
goal is to assess behavior and compliance. Research personnel conducting the screen will
ask everyday conversational questions. During the Zoom screening, research personnel will
answer any of the potential participants' and their parents' questions. The parent's' and
potential participants' responses will be recorded in REDCap (database is safe for PHI).
Adult and adolescent potential participants who are not able to carry on a conversation
or who express a lack of interest in the study/intervention will be excluded from the
study.
Participants who are not excluded during the phone/Zoom screen will be consented. After
consenting, in lieu of conducting autism diagnostic assessments, the investigators will
request a confirmation of an autism diagnosis or release of information from the medical
doctor, psychologist, or other specialist that provided the formal diagnosis of autism
spectrum disorder. This can be uploaded securely on REDCap by the participant in lieu of
testing. Additionally, the investigators will request information on participant
characteristics including current age, age of diagnosis, co-occurring diagnosis,
ethnicity, and gender (for the latter two categories there will be an option of "prefer
not to answer"), employment status, and number of social events engaged in per week for
each adolescent and adult participant. Parents of young children will also be asked to
complete a survey related to their child's current services and screen time.
Participants with common co-occurring conditions such as depression and anxiety will not
be excluded. This information may help us to understand if any co-occurring conditions
may affect the results of the study.
The investigators will match adult participants who are within 5 years of age and then
will randomly draw one name for the treatment group and one for the wait list group.
Adolescents and young children will not be matched but will be divided equally into
either the experimental group or the wait list control group.
Baseline Assessment:
Following informed consent/assent, the investigators will establish eligibility based on
review of records confirming the diagnosis of autism and inclusion criteria (i.e., ASD
diagnosis, willingness to participate, conversational (for adolescents/adults) needing
intervention based on low scores during the communication sample, or communication delays
for young children).
Eligible participants will be asked to chat or interact with a parent while the
investigators record a 15- to 20-minute communication sample (depending on how much
talking the potential participant engages in).
Communication Sample (to be collected pre and post intervention). For both the treatment
and wait list control groups. The communication sample will include a natural interaction
with someone who is aware of the experiment and will probe for targeted areas (e.g., for
the Empathy module the examiner will say statements such as "I'm feeling a little under
the weather today" to evoke an empathetic response). At least 5 opportunities will be
provided for the targeted area (e.g., empathy, taking the right amount, asking relevant
questions).
The communication sample will be recorded and saved on Stanford Medicine Box with a code
name (with no identifying participant information). Each response relevant to the study
will be scored. Participants who respond at 60% or higher during the communication sample
will not be included in the study as they are not in a range that warrants intervention.
Young children who do not show communication delays will not be included.
Comfort Scale. Prior to the start of intervention, the investigators will ask each adult
and adolescent participant who scores below 60% and is eligible for participation to fill
out a brief survey relating to their comfort in social situations (see pre- post
questionnaire attachment - AI scale).
Standardized Test of Vocabulary. Parents of young children will be asked to complete a
standardized measure of their child's words (i.e., the MacArthur-Bates Web-CDI) collected
at pre- and post-intervention. The MacArthur Bates Web-CDI is an online parent-report
assessment of their child's vocabulary (parents simply mark a check for words that their
child says).
Checklist of Targeted Vocabulary. Parents of young children will be asked to fill out a
checklist of the (approximately 250) target words included in the First Words Module.
DESIGN. This is a four-week randomized clinical trial (RCT). Three groups of 30, one for
young children (ages 3-10), one for the adolescent group (age 11-18), and a third for
adults (18-35) will be included. For each module, fifteen will participate in
intervention immediately after completing baseline measures and fifteen will be placed in
a wait list control group. Both groups will repeat the baseline measures (communication
sample and comfort scale) again after 4 weeks.
We will also include a pilot study arm. Participants will be added as their baselines are
stable and staggered according to multiple baseline design protocol.
Each RCT participant in the treatment group will be asked to participate for 4 weeks, at
least 10-20 trials a day, for at least 5 days per week. The investigators anticipate that
each session will take about ten minutes (unless the participant completes additional
practice). Our AI system will record the number of trials and the length of time each
participant engaged in the modules.
Intervention: The application will be delivered through a webapp. These modules have been
developed to provide feedback on specific areas following voice or text input (user
preference will be recorded in case this effects the results).
The investigators currently have developed AI modules for common social communication
challenges exhibited by individuals with ASD. Examples include:
Learning First Words, Empathy (general and in the work setting), Asking Relevant
Questions, Listen and Respond, Talking the right amount, Giving the Right Amount of
Personal Information, Tactful Responses, Giving Compliments, and Staying on Topic
During Conversation. These are all areas that can be challenging for individuals
diagnosed with autism spectrum disorder.
AI modules consist of thousands of total training examples. Participants may access the
modules on their phones or computers.
Each module will contain groups of 10-20 training examples, and the participants' verbal
responses will be analyzed and feedback provided.
Post Intervention:
Social Communication Sample. Following four weeks of intervention, an identical
communicaiton sample will be collected in exactly the same manner as the baseline. Again,
the communication samples collected via Zoom will be recorded and computer transcribed,
after which recordings will be erased.
Standardized Test of Vocabulary. Following four weeks of intervention, parents of young
children will be asked to complete the same standardized measure of their child's words
that was collected at baseline (i.e., the MacArthur-Bates Web-CDI).
Checklist of Targeted Vocabulary. Following four weeks of intervention, parents of young
children will be asked to fill out the same checklist of the (approximately 250) target
words included in the First Words Module that was collected at baseline.
Comfort and Acceptability Survey. Following intervention, adolescent and adult
participants in the treatment and wait list control group will be asked to complete a
survey relating to their comfort in social situations. This includes the questions asked
initially along with four additional questions related to the intervention (for
participants in the treatment group). Parents of young children will only be asked
questions related to the acceptability of the intervention.
For any participants who do not reach the 80% criterion during the four weeks of
intervention and who do not meet an 80% criterion during the communication sample, and
who wishes to receive additional intervention, an additional four weeks will be provided
and the communication sample will be repeated after an additional four weeks. If no
improvement occurs after the 8 weeks, they will be considered "nonresponders."
