Pilot of an AI-Enabled Autism Caregiver Support Tool in Indiana and Kenya
ConditionAutism Spectrum Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
AI-Enabled Autism Caregiver Support Tool
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: AI-Enabled Autism Caregiver Support ToolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recruitment rate
Recruitment feasibility measured as the proportion of eligible participants who enroll in the study, calculated as the number of enrolled participants divided by the number of eligible participants approached for study participation.
Time frame
Study enrollment period (up to 12 months)2
Retention rate
Participant retention measured as the proportion of enrolled participants who complete the final study follow-up assessment.
Time frame
Baseline to 6-month follow-up3
Assessment completion rate
Assessment feasibility measured as the proportion of participants who complete all required baseline and follow-up study assessments, including caregiver-reported outcome measures and implementation assessments.
Time frame
6 months4
Intervention Uptake
Intervention uptake measured as the proportion of enrolled participants who initiate at least one interaction with the AI-Enabled Autism Caregiver Support Tool following onboarding and activation.
Time frame
6 monthsSecondary outcomes
1
System Usability Scale (SUS)
Usability of the AI-Enabled Autism Caregiver Support Tool measured using the System Usability Scale (SUS), a validated measure of perceived usability and ease of use.
Time frame
6 months2
Participant Satisfaction With the Intervention
Participant satisfaction with the AI-Enabled Autism Caregiver Support Tool measured using study-specific satisfaction items assessing overall satisfaction, perceived usefulness, and likelihood of future use.
Time frame
6 months3
Autism Knowledge
Change in caregiver autism knowledge measured using the Autism Spectrum Knowledge Questionnaire (ASKQ-2), with higher scores indicating greater autism-related knowledge.
Time frame
Baseline and 6 months4
Unmet Caregiver Needs
Change in caregiver-reported unmet information, emotional support, service-navigation, and autism-related care needs using study-specific caregiver needs assessment items.
Time frame
Baseline and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov
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