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
調査の概要
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
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Ananda Ombitsa
- 電話番号:+254 718 748 223
- メール:rananda@ampath.or.ke
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
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Indiana
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Indianapolis、Indiana、アメリカ、46202
- Indiana University
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コンタクト:
- Kristen Cunningham, MPH, MS
- 電話番号:317-278-5675
- メール:kricunn@iu.edu
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Eldoret、ケニア
- Moi Teaching and Referral Hospital
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参加基準
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
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
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 |
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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.
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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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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 |
|---|---|---|
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Recruitment rate
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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System Usability Scale (SUS)
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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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協力者と研究者
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
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- AI Autism Caregiver Support
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
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
米国FDA規制機器製品の研究
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