AI-Enabled Support Tool for Autism

Not yet recruiting at 1 trial location
AO
KC
Overseen ByKristen Cunningham, MPH, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This prospective pilot study will evaluate an AI-enabled autism caregiver support tool for caregivers of children with autism in Indiana and Kenya. The tool is designed to provide evidence-based autism information, caregiver emotional support, and local service-navigation guidance, with safety guardrails and escalation pathways for high-risk concerns. Caregivers will receive access to the tool and complete baseline and follow-up assessments. The primary purpose of the study is to assess feasibility, acceptability, safety, engagement, and clinical-trial readiness. Exploratory caregiver outcomes include autism knowledge, caregiver self-efficacy, emotional distress and well-being, resource navigation, unmet needs, service engagement, satisfaction, and preparedness to take next steps after diagnosis. Findings will inform the design of a future fully powered effectiveness-implementation trial.

Who Is on the Research Team?

EO

Eren Oyungu, MBChB, MMED

Principal Investigator

Moi University

MM

Megan McHenry, MD, MS

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for caregivers of children with autism living in Indiana or Kenya. Participants should be able to use a digital tool and complete study assessments. There are no detailed exclusion criteria listed.

Inclusion Criteria

Able to provide informed consent
Has access to a mobile phone, tablet, or computer capable of accessing the AI-enabled caregiver support tool
Able to communicate in a study-supported language
See 4 more

Exclusion Criteria

I am younger than 18 years old.
Unable to access the AI-enabled caregiver support tool using an internet-connected device
Currently participating in another study that would interfere with study participation or interpretation of study findings
See 2 more

What Are the Treatments Tested in This Trial?

Interventions

  • AI-Enabled Autism Caregiver Support Tool

Trial Overview

The study is testing an AI-powered support tool that gives caregivers information about autism, emotional support, and help finding local services. Caregivers will use the tool and provide feedback on its usefulness, safety, and how easy it is to use.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: AI-Enabled Autism Caregiver Support ToolExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Moi University

Collaborator

Trials
40
Recruited
92,600+

Audere

Collaborator

Trials
2
Recruited
7,600+