Recruiting

AI

Sponsor:

Stanford University

Code:

NCT05987774

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 3 - 35

Healthy Volunteers: Not accepted

Interventions

AI Modules for Improving Social Communication

Study Details

Brief summary:

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT05987774

Start date

Oct 15, 2023

Status verified date

Aug, 2026

Completion date

Jun 30, 2050

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 35

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary diagnosis of autism spectrum disorder (ASD)
  • Age of adolescents and adults: between 11-35 years
  • Age of minimally verbal children: between 3-5 years
  • Ability to engage in social conversation using full sentences for a 20-minute period (adolescents and adults)
  • Verbal communication difficulties in an individual targeted area (e.g., empathy) as measured on the communication sample

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:

  • Non-documented or self-diagnosis of ASD
  • At or above 60% correct responding on targeted area of social conversation during conversation probe (adolescents and adults)
  • No significant language delay (young children)
  • No access to phone or computer for intervention sessions
  • Inability to carry on a conversation during the conversation probe
  • Apparent intellectual impairment that interferes with the ability to carry on a conversation (e.g., responds only in single words or does not respond to conversation, lack of understanding of questions or content during conversation probe)
  • Non-English speaking
  • Serious medical or psychiatric issues that may interfere with conversation or the ability to complete the program
  • Lack of interest in participating.

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention Group

This group will receive the treatment (AI conversation modules) available through the application.

no intervention: Control Group

This waitlist control group will not receive treatment until the experimental group completes their intervention.

Interventions

AI Modules for Improving Social Communication

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.

Primary outcome measure

  • Social Communication Sample [ Time Frame: Approximately 5-9 weeks per participant (4 weeks of intervention + pre and post measures + for adolescents and adults 1-month follow-up.) ]

Central Contacts and Locations

Central contacts

Lynn K Koegel, PhD

8056899493lynnk@stanford.edu

Monica Lam, PhD

6502240595lam@stanford.edu

Locations

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Lizzie Ponder, MA

lizzieP@Stanford.edu

Lynn Koegel, PhD

lynnk@Stanford.edu

More Information

Sponsor

Stanford University

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • AI
  • autism
  • LLMs
  • GPT
  • social skills
  • autism support
  • autism spectrum disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Stanford University on 2026-08-10.