- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Mikle South, PhD
- Telefonnummer: 860-299-4291
- E-mail: research@maphabit.com
Studiesteder
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- The Emory Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
Tidsramme: 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
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Depression Anxiety Stress Scales-21 (DASS-21) Score
Tidsramme: Baseline, 3 and 6 months post-intervention
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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
Tidsramme: Baseline, 3 and 6 months post-intervention
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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
Tidsramme: Baseline, 3 and 6 months post-intervention
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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
Tidsramme: Baseline, 3 and 6 months post-intervention
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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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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MapHabit Application Use Frequency
Tidsramme: 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
Tidsramme: Baseline, 3 and 6 months post-intervention
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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
Tidsramme: 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
Tidsramme: 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
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Patricia Aguayo, MD, Emory University
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2025P013877
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
De-identified individual participant data underlying the results reported in published articles.
IPD-delingstidsramme
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-delingsadgangskriterier
- 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-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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