このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

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

2026年9月9日 更新者: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.

調査の概要

状態

まだ募集していません

詳細な説明

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.

研究の種類

介入

入学 (推定)

60

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

  • 名前:Kristen Cunningham, MPH, MS
  • 電話番号:317-278-5675
  • メール:kricunn@iu.edu

研究場所

    • Indiana
      • Indianapolis、Indiana、アメリカ、46202
        • Indiana University
        • コンタクト:
          • Kristen Cunningham, MPH, MS
          • 電話番号:317-278-5675
          • メール:kricunn@iu.edu
      • Eldoret、ケニア
        • Moi Teaching and Referral Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Recruitment rate
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
System Usability Scale (SUS)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Eren Oyungu, MBChB, MMED、Moi University
  • 主任研究者:Megan McHenry, MD, MS、Indiana University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2028年1月1日

一次修了 (推定)

2029年1月1日

研究の完了 (推定)

2030年1月1日

試験登録日

最初に提出

2026年8月27日

QC基準を満たした最初の提出物

2026年9月9日

最初の投稿 (実際)

2026年9月16日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月16日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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.

IPD 共有時間枠

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.

IPD 共有アクセス基準

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.

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する