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

StatusNot Yet Recruiting
PhaseNot applicable
Started2028-01
View on ClinicalTrials.gov ↗
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.
Trial Details
NCT Number NCT07821619
Lead Sponsor Indiana University
Collaborators: Moi University, Audere
Conditions Autism Spectrum Disorder
Enrollment 60 participants
Start Date 2028-01
Primary Completion 2029-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-16