- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Mikle South, PhD
- Telefonní číslo: 860-299-4291
- E-mail: research@maphabit.com
Studijní místa
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Georgia
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Atlanta, Georgia, Spojené státy, 30322
- The Emory Clinic
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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MapHabit Application Use Frequency
Časové okno: Baseline, 3 and 6 months post-intervention
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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
Časové okno: 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
Časové okno: 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
Časové okno: Baseline, 3 and 6 months post-intervention
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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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Patricia Aguayo, MD, Emory University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025P013877
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
De-identified individual participant data underlying the results reported in published articles.
Časový rámec sdílení 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.
Kritéria přístupu pro sdílení 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.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
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