NCT07821619Not yet recruiting
Pilot of an AI-Enabled Autism Caregiver Support Tool in Indiana and Kenya
A Prospective Pilot Study of an AI-Enabled Autism Caregiver Support Tool to Assess Feasibility, Acceptability, Safety, Engagement, and Clinical-Trial Readiness in Indiana and Kenya
Source: ClinicalTrials.gov · Last updated 16 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Aug 2026
- Start date
- Jan 2028
- Primary completion date
- Jan 2029
- Lead sponsor
- Indiana University
- Diseases
- Autism
- NCT number
- NCT07821619
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Jan 2028 to the primary completion date, Jan 2029
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Younger than 18 years of age.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Moi Teaching and Referral Hospital Coordinator of this site? Confirm its status | Eldoret | Kenya | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.