AutismNCT07859306
Evaluating the Feasibility of Collecting User Interaction Data at the Emory Autism Center Using MapHabit Software
A study testing MapHabit System (MHS) in people with Autism and Autism Spectrum Disorder, run by Emory University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Autism, Autism Spectrum Disorder
- What is being tested?
- MapHabit System (MHS)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Children
- Inability to provide consent or lack of availability of a legally authorized representative
- Active crisis requiring intensive intervention
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Autism, Autism Spectrum Disorder
- Being tested
- MapHabit System (MHS)
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MapHabit System (MHS)Behavioural
Also called Investigational Digital Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| MapHabit System Arm | Experimental | Participants will use the MapHabit System for 6 months to help them accomplish activities of daily living and build independent habits. Receives: Behavioral: MapHabit System (MHS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
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.
Measured: Baseline, 3 and 6 months post-intervention
Depression Anxiety Stress Scales-21 (DASS-21) Score
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.
Measured: Baseline, 3 and 6 months post-intervention
Modified American Institutes for Research (AIR) Self-Determination Scale Total Score
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.
Measured: Baseline, 3 and 6 months post-intervention
Number of participants based on Vocational and Educational Participation Status
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.
Measured: Baseline, 3 and 6 months post-intervention
Number of Participants by Reliable Change Index (RCI) Classification
The RCI will be used to classify participants as improved, unchanged, or deteriorated based on meaningful change from baseline.
Measured: Baseline, 3 and 6 months post-intervention
Secondary outcomes (4)
MapHabit Application Use Frequency
Frequency of visual map use will be reported per participant by MapHabit system analytics. Higher values indicate greater use of the intervention.
Measured: Baseline, 3 and 6 months post-intervention
MapHabit Activity Adherence
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.
Measured: Baseline, 3 and 6 months post-intervention
Number of Maps Accessed or Created in MapHabit
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.
Measured: Baseline, 3 and 6 months post-intervention
Time Spent Using the MapHabit Application
Total duration of use of the MapHabit application during the study period, measured through automated backend analytics and reported in minutes per day.
Measured: Baseline, 3 and 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm feasibility study using a pre-post repeated-measures design where participants serve as their own controls.
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Aguayo, Emory University
- Investigators
- Patricia Aguayo, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07859306
- Sponsor's protocol ID
- 2025P013877
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the results reported in published articles.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Collecting User Interaction Data at the Emory Autism Center Using MapHabit Software
- ClinicalTrials.gov ID
- NCT07859306
- Acronym / sponsor ID
- 2025P013877
- Conditions
- Autism, Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm feasibility study using a pre-post repeated-measures design where participants serve as their own controls.
| Arm | Type | Receives |
|---|---|---|
| MapHabit System Arm | Experimental | Behavioral: MapHabit System (MHS)Participants will use the MapHabit System for 6 months to help them accomplish activities of daily living and build independent habits. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Children
- Inability to provide consent or lack of availability of a legally authorized representative
- Active crisis requiring intensive intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MapHabit System (MHS)Also: Investigational Digital InterventionThe 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. | Behavioural | MapHabit System Arm |
Primary outcome
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score
Time frame: 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.
Depression Anxiety Stress Scales-21 (DASS-21) Score
Time frame: 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.
Modified American Institutes for Research (AIR) Self-Determination Scale Total Score
Time frame: 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.
Number of participants based on Vocational and Educational Participation Status
Time frame: 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.
Number of Participants by Reliable Change Index (RCI) Classification
Time frame: 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.
4 secondary outcomes
MapHabit Application Use Frequency
Time frame: Baseline, 3 and 6 months post-intervention
MapHabit Activity Adherence
Time frame: Baseline, 3 and 6 months post-intervention
Number of Maps Accessed or Created in MapHabit
Time frame: Baseline, 3 and 6 months post-intervention
Time Spent Using the MapHabit Application
Time frame: Baseline, 3 and 6 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the results reported in published articles.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patricia Aguayo, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MapHabit System (MHS) in people with Autism and Autism Spectrum Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikle South, PhD (860-299-4291, research@maphabit.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life Brief Version (WHOQOL-BREF) Score (time frame: Baseline, 3 and 6 months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.