Stanford University School of Medicine
Stanford, California, 94305, United States
Location status: Recruiting
NCT Number: NCT05987774
The purpose of this study is to identify whether researched and commonly used face-to-face interventions can be effectively implemented through artificial intelligence (AI) using an application on the phone or computer. The investigators plan to recruit individuals diagnosed with autism spectrum disorder who demonstrate challenges with social communication. Modules focusing on various difficulties experienced by autistic individuals will provide practice and feedback using voice recognition and feedback. If effective, this intervention can be scaled up to provide cost-effective accessible assistance to individuals, particularly those who do not have access to care or prefer to secure services in the comfort of their own homes.
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Request Info3 year–35 year
All sexes
Interventional
Not applicable
Stanford, California, 94305, United States
Location status: Recruiting
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."
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants with a co-occuring diagnosis of ADHD, depression, or social anxiety will not be excluded since these are very common in this population and are often related to or a bi-product of difficulties with social communication.
Exclusion criteria
The modules will be accessed via a web app. 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, tablets, or computers.
Time frame: Approximately 5-9 weeks per participant (4 weeks of intervention + pre and post measures + for adolescents and adults 1-month follow-up.)
Measured in terms of what percentage of responses (0% - 100%) during the investigators' social conversation sample are answered appropriately for adolescents and adults or number of spoken words for young children. Each of the participants' responses will be evaluated by a MA or PhD-level expert. Social communication samples will be collected via Zoom, recorded and computer transcribed, after which recordings will be erased. An initial sample will be collected at baseline, after four weeks of intervention, and at post-intervention.
Time frame: Approximately 5-6 weeks
Likert scale that ranges from 1 - 5. 1 is the minimum value (the worst outcome) and 5 is the maximum value (the best outcome).
Prior to and following intervention, adolescent and adult participants in the treatment and wait list control group will be asked to complete a self-evaluated survey relating to their comfort in social situations. Participants in the treatment group (including parents of young children) will also be asked to fill out a Likert scale relating to their satisfaction with the intervention.
Time frame: Approximately 4-5 weeks per participant
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).
Time frame: Approximately 4-5 weeks per participant
This measure is a checklist of the (approximately 250) target words included in the First Words Module that asks parents of young children to indicate if their child understands, understands and says, says but does not understand, or does not say or understand the word. This will be given to parents of young children pre- and post-intervention.
Contact information is provided by the study sponsor or research team.
Lynn K Koegel, PhD
CONTACT
Monica Lam, PhD
CONTACT
Stanford University
Other
Using Artificial Intelligence (AI) to Improve Social Communication in Autistic Individuals
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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