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

9 сентября 2026 г. обновлено: Megan Song McHenry, Indiana University

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

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.

Обзор исследования

Статус

Еще не набирают

Условия

Вмешательство/лечение

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Оцененный)

60

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Ananda Ombitsa
  • Номер телефона: +254 718 748 223
  • Электронная почта: rananda@ampath.or.ke

Учебное резервное копирование контактов

  • Имя: Kristen Cunningham, MPH, MS
  • Номер телефона: 317-278-5675
  • Электронная почта: kricunn@iu.edu

Места учебы

  • Кения
      • Eldoret, Кения
        • Moi Teaching and Referral Hospital
  • Соединенные Штаты
    • Indiana
      • Indianapolis, Indiana, Соединенные Штаты, 46202
        • Indiana University
        • Контакт:
          • Kristen Cunningham, MPH, MS
          • Номер телефона: 317-278-5675
          • Электронная почта: kricunn@iu.edu

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

  • Взрослый
  • Пожилой взрослый

Принимает здоровых добровольцев

Нет

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Поддерживающая терапия
  • Распределение: Н/Д
  • Интервенционная модель: Одногрупповое задание
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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.
Поведенческий: AI-Enabled Autism Caregiver Support Tool
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.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Recruitment rate
Временное ограничение: Study enrollment period (up to 12 months)
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.
Study enrollment period (up to 12 months)
Retention rate
Временное ограничение: Baseline to 6-month follow-up
Participant retention measured as the proportion of enrolled participants who complete the final study follow-up assessment.
Baseline to 6-month follow-up
Assessment completion rate
Временное ограничение: 6 months
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.
6 months
Intervention Uptake
Временное ограничение: 6 months
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.
6 months
Intervention Engagement
Временное ограничение: 6 months
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.
6 months
Safety Events and Escalations
Временное ограничение: Baseline through 6 months
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.
Baseline through 6 months
Acceptability of the Intervention
Временное ограничение: 6 months
Acceptability of the AI-Enabled Autism Caregiver Support Tool measured using the Acceptability of Intervention Measure (AIM), with higher scores indicating greater perceived acceptability.
6 months
Feasibility of the Intervention
Временное ограничение: 6 months
Feasibility of the AI-Enabled Autism Caregiver Support Tool measured using the Feasibility of Intervention Measure (FIM), with higher scores indicating greater perceived feasibility.
6 months
Appropriateness of the Intervention
Временное ограничение: 6 months
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.
6 months

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
System Usability Scale (SUS)
Временное ограничение: 6 months
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.
6 months
Participant Satisfaction With the Intervention
Временное ограничение: 6 months
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.
6 months
Autism Knowledge
Временное ограничение: Baseline and 6 months
Change in caregiver autism knowledge measured using the Autism Spectrum Knowledge Questionnaire (ASKQ-2), with higher scores indicating greater autism-related knowledge.
Baseline and 6 months
Unmet Caregiver Needs
Временное ограничение: Baseline and 6 months
Change in caregiver-reported unmet information, emotional support, service-navigation, and autism-related care needs using study-specific caregiver needs assessment items.
Baseline and 6 months
Trust in the AI-Enabled Autism Caregiver Support Tool
Временное ограничение: 6 months
Participant-reported trust in the information, guidance, and recommendations provided by the AI-Enabled Autism Caregiver Support Tool using study-specific trust measures.
6 months
Preparedness to Take Next Steps Following Autism Diagnosis
Временное ограничение: Baseline and 6 months
Change in caregiver-reported preparedness to make decisions regarding autism-related services, supports, educational planning, and care coordination.
Baseline and 6 months
Service Engagement
Временное ограничение: Baseline and 6 months
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.
Baseline and 6 months
Resource Navigation
Временное ограничение: Baseline and 6 months
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.
Baseline and 6 months
Caregiver Well-Being
Временное ограничение: Baseline and 6 months
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.
Baseline and 6 months
Perceived Access to Reliable Information
Временное ограничение: Baseline and 6 months
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.
Baseline and 6 months
Caregiver Self-Efficacy
Временное ограничение: Baseline and 6 months
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.
Baseline and 6 months

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Indiana University

Соавторы

Moi University
Audere

Следователи

  • Главный следователь: Eren Oyungu, MBChB, MMED, Moi University
  • Главный следователь: Megan McHenry, MD, MS, Indiana University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Оцененный)

1 января 2028 г.

Первичное завершение (Оцененный)

1 января 2029 г.

Завершение исследования (Оцененный)

1 января 2030 г.

Даты регистрации исследования

Первый отправленный

27 августа 2026 г.

Впервые представлено, что соответствует критериям контроля качества

9 сентября 2026 г.

Первый опубликованный (Действительный)

16 сентября 2026 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

16 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

9 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • AI Autism Caregiver Support

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

De-identified quantitative data may be shared in accordance with participant consent, IRB approvals, data-use agreements, and applicable U.S. and Kenyan regulations. Raw conversational transcripts will not be publicly shared because they may contain sensitive caregiver, child, clinical, or location-specific information.

Сроки обмена IPD

Data will become available within 12 months of publication of the primary study results and will remain available for at least 5 years following publication.

Критерии совместного доступа к IPD

Access to de-identified quantitative data will require submission of a data request, approval by the study investigators, execution of an appropriate data use agreement, and compliance with applicable institutional, U.S., and Kenyan regulations governing human subjects research and data sharing.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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