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Not Yet Recruiting NCT07821619

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

Conditions: Autism Spectrum Disorder

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Indiana University

Location: Indiana University Indianapolis Indiana

Summary

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.

Eligibility Criteria

Inclusion Criteria: * Adult caregiver aged 18 years or older. * Parent or primary caregiver of a child with autism spectrum disorder. * Resides within the study catchment area in Indiana, United States or western Kenya. * 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. * Willing to use the AI-enabled caregiver support tool and complete study assessments. Exclusion Criteria: * Younger than 18 years of age. * Unable or unwilling to provide informed consent. * Unable to access the AI-enabled caregiver support tool using an internet-connected device. * Unable to complete study procedures or assessments due to cognitive, communication, or other limitations that preclude participation. * Currently participating in another study that, in the opinion of the investigators, would interfere with study participation or interpretation of study findings.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07821619). StuddyBuddy aggregates publicly available trial information.