NCT05987774

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 verbal individuals diagnosed with autism spectrum disorder who demonstrate challenges with socialization. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
540

participants targeted

Target at P75+ for not_applicable

Timeline
293mo left

Started Oct 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Oct 2023Jun 2050

First Submitted

Initial submission to the registry

July 26, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 15, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
23 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2050

Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

3.7 years

First QC Date

July 26, 2023

Last Update Submit

May 20, 2024

Conditions

Keywords

AIautismLLMsGPTsocial skillsautism supportautism spectrum disorder

Outcome Measures

Primary Outcomes (1)

  • Social Conversation Sample

    Measured in terms of what percentage of responses (0% - 100%) during the investigators' social conversation sample are answered appropriately. Each of the participants' responses will be evaluated by a MA or PhD-level expert. Social conversation samples will be collected via zoom, audio recorded and computer transcribed, after which audio recordings will be erased. An initial sample will be collected at baseline, after four weeks of intervention, and at post-intervention.

    Approximately 9 weeks per participant (4 weeks of intervention + pre and post measures + 1-month follow-up)

Secondary Outcomes (1)

  • Social Validity Scale

    Approximately 5-6 weeks

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Device: AI Modules for Improving Social Conversation

Control Group

NO INTERVENTION

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

Interventions

The application if the modules will be delivered using software. 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: 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.

Intervention Group

Eligibility Criteria

Age11 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Primary diagnosis of autism spectrum disorder (ASD)
  • Age between 11 to 35
  • Ability to engage in social conversation using full sentences for a 20 minute period
  • Verbal communication difficulties in an individual targeted area (e.g., empathy) as measured on the conversation 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 conversation.

You may not qualify if:

  • Non-documented or self-diagnosis of ASD
  • At or above 60% correct responding on targeted area of social conversation during conversation probe
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum DisorderAutistic DisorderSocial Skills

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSocial BehaviorBehavior

Central Study Contacts

Lynn K Koegel, PhD

CONTACT

Monica Lam, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 14, 2023

Study Start

October 15, 2023

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2050

Last Updated

May 22, 2024

Record last verified: 2024-05

Locations