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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Families of children with autism often face significant challenges following diagnosis, including difficulty accessing reliable information, navigating complex systems of care, identifying appropriate services, and managing the emotional demands associated with caregiving. These challenges may be particularly pronounced in rural, underserved, and resource-constrained settings where access to specialty autism services and family navigation support is limited.
This study will evaluate an AI-enabled autism caregiver support tool designed to provide evidence-based autism information, caregiver emotional support, and service-navigation guidance for caregivers of children with autism in Indiana, United States, and western Kenya. The intervention was developed through a reciprocal innovation approach involving partners in both settings and was informed by caregiver, clinician, educator, and community stakeholder input. The tool is designed to provide plain-language information about autism, answer frequently asked caregiver questions, help caregivers identify relevant services and resources, and provide supportive coping guidance. Safety guardrails are incorporated to address crisis, medical, diagnostic, treatment-related, and other high-risk questions. The tool is not intended to diagnose autism, replace clinical care, or provide emergency services.
The study will use a prospective single-arm pre-post pilot design. Approximately 60 caregivers of children with autism will be recruited in Indiana and Kenya and provided access to the AI-enabled caregiver support tool. Participants will complete baseline and follow-up assessments and will have access to the intervention throughout the study period. Usage data, including engagement with the tool, use of resource-navigation features, and safety-related interactions, will also be collected.
The primary focus of the study is to evaluate feasibility, acceptability, safety, engagement, and clinical-trial readiness. Specific outcomes will include recruitment, retention, assessment completion, intervention uptake, participant engagement, safety events and escalations, usability, and implementation outcomes such as acceptability, feasibility, and appropriateness.
Additional exploratory outcomes will include autism knowledge, caregiver self-efficacy, access to reliable information, emotional well-being, service navigation, unmet caregiver needs, service engagement, preparedness to take next steps following diagnosis, satisfaction with the intervention, and trust in the AI-enabled caregiver support tool. These outcomes will be used to estimate outcome variability and inform selection of measures for a future fully powered effectiveness-implementation study.
By evaluating an AI-enabled caregiver support intervention in both Indiana and Kenya, this study will generate important information regarding implementation, safety, usability, engagement, and caregiver support needs across diverse cultural and resource settings. Findings will inform future efforts to develop scalable approaches for improving access to autism information, caregiver support, and service navigation for families of children with autism.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ananda Ombitsa
- Número de teléfono: +254 718 748 223
- Correo electrónico: rananda@ampath.or.ke
Copia de seguridad de contactos de estudio
- Nombre: Kristen Cunningham, MPH, MS
- Número de teléfono: 317-278-5675
- Correo electrónico: kricunn@iu.edu
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University
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Contacto:
- Kristen Cunningham, MPH, MS
- Número de teléfono: 317-278-5675
- Correo electrónico: kricunn@iu.edu
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Eldoret, Kenia
- Moi Teaching and Referral Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: AI-Enabled Autism Caregiver Support Tool
Caregivers of children with autism will receive access to an AI-enabled caregiver support tool that provides evidence-based autism information, resource navigation support, and caregiver emotional support.
Participants will use the tool during the study period and complete baseline and follow-up assessments to evaluate feasibility, acceptability, safety, engagement, and preliminary caregiver outcomes.
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Participants 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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Recruitment rate
Periodo de tiempo: Study enrollment period (up to 12 months)
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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.
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Study enrollment period (up to 12 months)
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Retention rate
Periodo de tiempo: Baseline to 6-month follow-up
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Participant retention measured as the proportion of enrolled participants who complete the final study follow-up assessment.
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Baseline to 6-month follow-up
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Assessment completion rate
Periodo de tiempo: 6 months
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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.
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6 months
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Intervention Uptake
Periodo de tiempo: 6 months
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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.
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6 months
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Intervention Engagement
Periodo de tiempo: 6 months
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Participant engagement with the AI-Enabled Autism Caregiver Support Tool measured using platform analytics, including number of sessions, active use days, questions submitted, conversations completed, and use of resource navigation and caregiver-support features.
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6 months
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Safety Events and Escalations
Periodo de tiempo: Baseline through 6 months
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Safety of the intervention measured by the number and proportion of high-risk prompts, safety escalations, adverse events, and interactions requiring referral to clinical, crisis, or emergency resources.
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Baseline through 6 months
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Acceptability of the Intervention
Periodo de tiempo: 6 months
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Acceptability of the AI-Enabled Autism Caregiver Support Tool measured using the Acceptability of Intervention Measure (AIM), with higher scores indicating greater perceived acceptability.
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6 months
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Feasibility of the Intervention
Periodo de tiempo: 6 months
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Feasibility of the AI-Enabled Autism Caregiver Support Tool measured using the Feasibility of Intervention Measure (FIM), with higher scores indicating greater perceived feasibility.
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6 months
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Appropriateness of the Intervention
Periodo de tiempo: 6 months
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Perceived appropriateness of the AI-Enabled Autism Caregiver Support Tool measured using the Intervention Appropriateness Measure (IAM), with higher scores indicating greater perceived fit, relevance, and suitability for caregiver support.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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System Usability Scale (SUS)
Periodo de tiempo: 6 months
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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.
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6 months
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Participant Satisfaction With the Intervention
Periodo de tiempo: 6 months
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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.
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6 months
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Autism Knowledge
Periodo de tiempo: Baseline and 6 months
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Change in caregiver autism knowledge measured using the Autism Spectrum Knowledge Questionnaire (ASKQ-2), with higher scores indicating greater autism-related knowledge.
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Baseline and 6 months
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Unmet Caregiver Needs
Periodo de tiempo: Baseline and 6 months
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Change in caregiver-reported unmet information, emotional support, service-navigation, and autism-related care needs using study-specific caregiver needs assessment items.
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Baseline and 6 months
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Trust in the AI-Enabled Autism Caregiver Support Tool
Periodo de tiempo: 6 months
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Participant-reported trust in the information, guidance, and recommendations provided by the AI-Enabled Autism Caregiver Support Tool using study-specific trust measures.
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6 months
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Preparedness to Take Next Steps Following Autism Diagnosis
Periodo de tiempo: Baseline and 6 months
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Change in caregiver-reported preparedness to make decisions regarding autism-related services, supports, educational planning, and care coordination.
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Baseline and 6 months
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Service Engagement
Periodo de tiempo: Baseline and 6 months
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Change in caregiver-reported engagement with autism-related clinical, educational, behavioral, and community-based services, measured using study-specific service utilization questionnaires documenting referral completion, service initiation, attendance, and ongoing participation in recommended services.
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Baseline and 6 months
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Resource Navigation
Periodo de tiempo: Baseline and 6 months
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Change in caregiver ability to identify, access, and utilize autism-related services and supports, measured using service-navigation items adapted from the National Survey of Children's Health (NSCH), referral completion, service access, and follow-up engagement indicators.
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Baseline and 6 months
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Caregiver Well-Being
Periodo de tiempo: Baseline and 6 months
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Change in caregiver well-being measured using the World Health Organization-Five Well-Being Index (WHO-5), with higher scores indicating greater psychological well-being.
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Baseline and 6 months
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Perceived Access to Reliable Information
Periodo de tiempo: Baseline and 6 months
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Change in caregiver-reported access to trustworthy, understandable, and evidence-based autism-related information, measured using study-specific items assessing confidence in locating, understanding, and using autism-related information for decision-making and service navigation.
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Baseline and 6 months
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Caregiver Self-Efficacy
Periodo de tiempo: Baseline and 6 months
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Change in caregiver self-efficacy and empowerment measured using the Family Empowerment Scale, including confidence in managing autism-related needs, navigating services, and advocating for their child.
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Baseline and 6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Eren Oyungu, MBChB, MMED, Moi University
- Investigador principal: Megan McHenry, MD, MS, Indiana University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- AI Autism Caregiver Support
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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