← Back to all trials
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.
Source: ClinicalTrials.gov (NCT07821619). StuddyBuddy aggregates publicly available trial information.