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。

Evaluating the Feasibility of Collecting User Interaction Data at the Emory Autism Center Using MapHabit Software

2026年9月29日 更新者:Patricia Aguayo、Emory University

The purpose of this study is to evaluate the impact of the MapHabit System on autistic transition-age youth (ages 18-24) as they navigate key life transitions including graduating from high school, entering adult services, pursuing employment or education, and community-based living.

調査の概要

状態

まだ募集していません

詳細な説明

This study aims to evaluate whether the MAPHabit System can improve functional ability and quality of life in autistic transition-age young adults (ages 18-30) during key life transitions by teaching skills and providing cognitive support. MAPHabit is a daily living support app to help individuals, caregivers, and families build routines and increase independence.

The study will recruit at Emory Autism Center (Georgia) 140 autistic young adults ages 18-30 who are navigating transitions such as graduating high school, entering adult services, pursuing employment or education, and community-based living. Each participant will be in the study for 6 months.

The study uses a single-arm, pre-post design where participants complete some outcome assessments at baseline, 3 months, and 6 months while using the MapHabit visual mapping intervention.

研究の種類

介入

入学 (推定)

140

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

研究場所

    • Georgia
      • Atlanta、Georgia、アメリカ、30322
        • The Emory Clinic

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

18年~24年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 18 -24 years old at time of enrollment
  • Documented diagnosis of Autism, confirmed through prior clinical evaluation and diagnostic reports
  • Ability to provide informed consent independently or availability of legally authorized representative

Exclusion Criteria:

  • Children
  • Inability to provide consent or lack of availability of a legally authorized representative
  • Active crisis requiring intensive intervention

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:MapHabit System Arm

Participants will use the MapHabit System for 6 months to help them accomplish activities of daily living and build independent habits.

The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes visual, audio, and text media to create step-by-step visual guides to help participants accomplish activities of daily living (ADL) and build independent habits. The goal of the application is to develop and facilitate habits and routines using structured visual and auditory stimuli that can be customized by the user and can include educational and lesson-based material in addition to ADLs. It will be delivered using mobile application (iOS/Android tablets provided to participants) and/or printed materials.

他の名前:
  • Investigational Digital Intervention

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
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
時間枠:Baseline, 3 and 6 months post-intervention

Quality of life as assessed by the WHOQOL-BREF, a 26-item self-report questionnaire measuring physical health, psychological health, social relationships, and environmental domains. Domain scores are transformed to a scale ranging from 0 to 100, with higher scores indicating better quality of life.

Baseline, 3 and 6 months post-intervention
Depression Anxiety Stress Scales-21 (DASS-21) Score
時間枠:Baseline, 3 and 6 months post-intervention

Psychological distress as assessed by the DASS-21, a 21-item self-report measure of depression, anxiety, and stress symptoms. Total scores range from 0 to 63, with higher scores indicating greater psychological distress and symptom severity.

Baseline, 3 and 6 months post-intervention
Modified American Institutes for Research (AIR) Self-Determination Scale Total Score
時間枠:Baseline, 3 and 6 months post-intervention

Assessed by a modified AIR Self-Determination Scale evaluating self-determination capacity and opportunity, including autonomy, self-regulation, psychological empowerment, and goal-directed behavior, with additional items related to employment and educational outcomes. The overall self-determination score is reported as a percentage from 0% to 100%, with higher scores indicating greater self-determination.

Baseline, 3 and 6 months post-intervention
Number of participants based on Vocational and Educational Participation Status
時間枠:Baseline, 3 and 6 months post-intervention

Participation in employment, vocational training, educational programs, volunteer activities, and other structured weekly activities as assessed by a vocational and educational interview. This outcome includes the number of participants engaged in each activity category at the assessment time point.

Baseline, 3 and 6 months post-intervention
Number of Participants by Reliable Change Index (RCI) Classification
時間枠:Baseline, 3 and 6 months post-intervention

The RCI will be used to classify participants as improved, unchanged, or deteriorated based on meaningful change from baseline.

Baseline, 3 and 6 months post-intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
MapHabit Application Use Frequency
時間枠:Baseline, 3 and 6 months post-intervention

Frequency of visual map use will be reported per participant by MapHabit system analytics. Higher values indicate greater use of the intervention.

Baseline, 3 and 6 months post-intervention
MapHabit Activity Adherence
時間枠:Baseline, 3 and 6 months post-intervention

Adherence to planned activities supported by the MapHabit application as measured by MapHabit system analytics. Adherence will be assessed based on participant completion and use patterns recorded within the platform. Higher adherence values indicate greater engagement with intervention-related activities.

Baseline, 3 and 6 months post-intervention
Number of Maps Accessed or Created in MapHabit
時間枠:Baseline, 3 and 6 months post-intervention

Participant engagement with the MapHabit system as measured by the total number of visual maps created and/or accessed during the study period, as captured through automated backend analytics. Higher values indicate greater platform utilization.

Baseline, 3 and 6 months post-intervention
Time Spent Using the MapHabit Application
時間枠:Baseline, 3 and 6 months post-intervention

Total duration of use of the MapHabit application during the study period, measured through automated backend analytics and reported in minutes per day.

Baseline, 3 and 6 months post-intervention

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:Patricia Aguayo, MD、Emory 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)

2026年9月1日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2026年9月29日

QC基準を満たした最初の提出物

2026年9月29日

最初の投稿 (実際)

2026年10月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月5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29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

その他の研究ID番号

  • 2025P013877

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 individual participant data underlying the results reported in published articles.

IPD 共有時間枠

Start: 12 months after publication of the primary results. If primary results are not published within 24 months of study completion, data will become available 24 months after study completion. End: 5 years after the start date.

IPD 共有アクセス基準

  • Data will be shared with qualified investigators at research institutions whose institution can execute a data use agreement, and who hold IRB approval or a formal exemption/non-human-subjects determination for the proposed secondary analysis.
  • For any methodologically sound proposal consistent with the consent participants provided, including replication of published analyses, secondary analyses of the study measures, and inclusion in individual-participant-data meta-analyses. Prohibited uses include any attempt at re-identification, redistribution to third parties, and commercial or marketing use.
  • Data will be deposited with [the Inter-university Consortium for Political and Social Research (ICPSR)] as a restricted-use collection. Requests will be reviewed and administered by the repository, with access provided through its secure environment. The study team will not adjudicate requests individually. The dataset DOI will be added to this registration record upon deposit.

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

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