- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07859306
Evaluating the Feasibility of Collecting User Interaction Data at the Emory Autism Center Using MapHabit Software
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Mikle South, PhD
- Номер телефона: 860-299-4291
- Электронная почта: research@maphabit.com
Места учебы
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Georgia
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Atlanta, Georgia, Соединенные Штаты, 30322
- The Emory Clinic
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
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 |
|---|---|
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Экспериментальный: 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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
Временное ограничение: 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
Временное ограничение: 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
|
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Modified American Institutes for Research (AIR) Self-Determination Scale Total Score
Временное ограничение: 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
|
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Number of participants based on Vocational and Educational Participation Status
Временное ограничение: 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
|
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Number of Participants by Reliable Change Index (RCI) Classification
Временное ограничение: 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
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
MapHabit Application Use Frequency
Временное ограничение: 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
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MapHabit Activity Adherence
Временное ограничение: 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
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Number of Maps Accessed or Created in MapHabit
Временное ограничение: Baseline, 3 and 6 months post-intervention
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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
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Time Spent Using the MapHabit Application
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Patricia Aguayo, MD, Emory University
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025P013877
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
De-identified individual participant data underlying the results reported in published articles.
Сроки обмена IPD
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.
Критерии совместного доступа к IPD
- 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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
- АНАЛИТИЧЕСКИЙ_КОД
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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