Pilot of an AI-Enabled Autism Caregiver Support Tool in Indiana and Kenya

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor: Indiana University
Study ID: NCT07821619
Status: Not Yet Recruiting

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Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

AI-Enabled Autism Caregiver Support Tool — BEHAVIORAL
Participants will receive access to an AI-enabled autism caregiver support tool adapted for their local setting. The tool provides plain-language, evidence-based information about autism; answers caregiver questions; supports caregiver coping; helps families identify relevant services and resources; and includes safety guardrails for crisis, medical, diagnostic, behavioral, and treatment-related questions. The tool is not intended to diagnose autism, replace clinical care, or provide emergency services.

Study Details

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.

Key Dates

First listed: Sep 16, 2026
Start date: Jan 31, 2028
Status verified: Sep 2026
Primary completion: Jan 31, 2029
Completion: Jan 31, 2030

Study Design

Enrollment: 60 participants (estimated)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Arms

Experimental: AI-Enabled Autism Caregiver Support Tool
Caregivers of children with autism will receive access to an AI-enabled caregiver support tool that provides evidence-based autism information, resource navigation support, and caregiver emotional support. Participants will use the tool during the study period and complete baseline and follow-up assessments to evaluate feasibility, acceptability, safety, engagement, and preliminary caregiver outcomes.