- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Mikle South, PhD
- Telefonnummer: 860-299-4291
- E-post: research@maphabit.com
Studieorter
-
-
Georgia
-
Atlanta, Georgia, Förenta staterna, 30322
- The Emory Clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
MapHabit Application Use Frequency
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Patricia Aguayo, MD, Emory University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025P013877
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
De-identified individual participant data underlying the results reported in published articles.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
- 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-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
- ANALYTIC_CODE
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