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Evaluating the Feasibility of Collecting User Interaction Data at the Emory Autism Center Using MapHabit Software

29 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

140

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • The Emory Clinic

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 24 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Cuidados de apoyo
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

Otros nombres:
  • Investigational Digital Intervention

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
MapHabit Application Use Frequency
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Patricia Aguayo, MD, Emory University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de septiembre de 2027

Finalización del estudio (Estimado)

1 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

29 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Publicado por primera vez (Actual)

5 de octubre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

29 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 2025P013877

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir 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.

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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