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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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

140

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • Georgia
      • Atlanta、Georgia、美国、30322
        • The Emory Clinic

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 24年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：MapHabit System Arm

Participants will use the MapHabit System for 6 months to help them accomplish activities of daily living and build independent habits.
行为的：MapHabit System (MHS)

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.

其他名称：
  • Investigational Digital Intervention

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
MapHabit Application Use Frequency
大体时间：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
大体时间：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
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Emory University

调查人员

  • 首席研究员：Patricia Aguayo, MD、Emory University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年9月1日

研究完成 (估计的)

2027年9月1日

研究注册日期

首次提交

2026年9月29日

首先提交符合 QC 标准的

2026年9月29日

首次发布 (实际的)

2026年10月5日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年9月29日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2025P013877

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in published articles.

IPD 共享时间框架

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 共享访问标准

  • 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 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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