Down SyndromeNCT05343468
Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
A study testing The MapHabit System in people with Down Syndrome and Adaptive Behavior, run by MapHabit, Inc. at 1 site in United States.
Trial summary
Enhancing independence and quality of life are key modifiable outcomes that are short- and long-term goals for children with Down syndrome (DS) and for their parents. The study investigated the efficacy of assistive technology in improving children with Down Syndrome's independence and quality of life. Read more about this study
- Who is it for?
- Ages 7 to 17 years
- Conditions the study is for
- Down Syndrome, Adaptive Behavior, Quality of Life
- What is being tested?
- The MapHabit System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2020to 5 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 7 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Down syndrome diagnosis
- Age between 7-17
- Internet access
- Proficiency in English
Who cannot join
- Ages outside of 7-17
- Located outside of the United States of America
- No internet access
- No proficiency in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Independence, Quality of Life, and Adaptive Behavioral Skills Improved in Children With Down Syndrome After Using Assistive Technology
Enhancing independence and quality of life are key modifiable outcomes that are short- and long-term goals for children with Down syndrome (DS) and for their parents. The study investigated the efficacy of assistive technology in improving children with Down Syndrome's independence and quality of life. Using a commercially available assistive technology, the MapHabit system, the investigators implemented the software with participants' families for 4 weeks. The investigators hypothesized that the assistive technology will improve adaptive behavioral skills and overall quality of life.
- Conditions
- Down Syndrome, Adaptive Behavior, Quality of Life
- Being tested
- The MapHabit System
- Keywords
- Down syndrome, Assistive technology, Adaptive behavioral skills
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The MapHabit SystemDevice
The MapHabit System (MHS) is a commercially available visual mapping software application that utilize visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). 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. The application was made available to families through compatible smartphones and tablets.
The MHS is a general wellness product and there is no regulatory oversight of the MapHabit System mapping functionality. This functionality is not a regulated medical device.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Singe-arm: the assistive digital software was implemented as an intervention to all participants. Receives: Device: The MapHabit System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adaptive Behavior Assessment System Third Edition (ABAS-3) from Baseline at 4 Weeks
Assessment is used commonly for children with Down syndrome that evaluates conceptual, social, and practical behavioral skills that are significant for day-to-day functioning. The assessment is scored with the General Adaptive Composite (GAC), which summarizes performance across all adaptive skill areas. GAC score ranges from 0-130, with a higher score indicating better outcome.
Measured: Pre-Post: The assessment was administered at the beginning and end of the study's duration (4-week study).
Quality of Life - 18 (QoL-18)
18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-5. A higher number indicates better outcome.
Measured: The instrument was administered to the participants after the completion of the study duration (4-week study).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start20 Sep 2020
- Primary completion18 Jun 2021
- Study completion5 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- 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 single-arm repeated measures design examined the effects of a software device as an intervention, permitting the participants to serve as their own controls.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- MapHabit, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- LuMind IDSC Foundation, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Stuart Zola, MapHabit, Inc.
- Investigators
- Stuart Zola, PhD, Principal investigator, MapHabit, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343468
- Sponsor's protocol ID
- LuMind Study
- Other IDs
- 5R43AG065081-02
- Status last verified
- Feb 2023
- First submitted
- 5 Apr 2022
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Boatman F, Golden M, Jin J, Kim Y, Law S, Lu A, Merriam N, Zola S. Assistive technology: Visual mapping combined with mobile software can enhance quality of life and ability to carry out activities of daily living in individuals with impaired memory. Technol Health Care. 2020;28(2):121-128. doi: 10.3233/THC-191980.
PubMed 31796718Kelleher J, Zola S, Cui X, Chen S, Gerber C, Parker MW, Davis C, Law S, Golden M, Vaughan CP. Personalized Visual Mapping Assistive Technology to Improve Functional Ability in Persons With Dementia: Feasibility Cohort Study. JMIR Aging. 2021 Oct 19;4(4):e28165. doi: 10.2196/28165.
PubMed 34269690Parker MW, Davis C, White K, Johnson D, Golden M, Zola S. Reduced care burden and improved quality of life in African American family caregivers: Positive impact of personalized assistive technology. Technol Health Care. 2022;30(2):379-387. doi: 10.3233/THC-213049.
PubMed 34334439White K, Han SS, Britton A, Hendrix J. A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technology. PLoS One. 2023 May 24;18(5):e0284738. doi: 10.1371/journal.pone.0284738. eCollection 2023.
PubMed 37224142
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Independence, Quality of Life, and Adaptive Behavioral Skills Improved in Children With Down Syndrome After Using Assistive Technology
- ClinicalTrials.gov ID
- NCT05343468
- Acronym / sponsor ID
- LuMind Study
- Conditions
- Down Syndrome, Adaptive Behavior, Quality of Life
- Keywords
- Down syndrome, Assistive technology, Adaptive behavioral skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- MapHabit, Inc.Industry (pharma, biotech, devices)
- Collaborators
- LuMind IDSC Foundation, National Institute on Aging (NIA)
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 18 Jun 2021 (actual)
- Study completion
- 5 Aug 2021 (actual)
- First posted
- 25 Apr 2022 (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.
Enhancing independence and quality of life are key modifiable outcomes that are short- and long-term goals for children with Down syndrome (DS) and for their parents. The study investigated the efficacy of assistive technology in improving children with Down Syndrome's independence and quality of life. Using a commercially available assistive technology, the MapHabit system, the investigators implemented the software with participants' families for 4 weeks. The investigators hypothesized that the assistive technology will improve adaptive behavioral skills and overall quality of life.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This single-arm repeated measures design examined the effects of a software device as an intervention, permitting the participants to serve as their own controls.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: The MapHabit SystemSinge-arm: the assistive digital software was implemented as an intervention to all participants. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Down syndrome diagnosis
- Age between 7-17
- Internet access
- Proficiency in English
Key exclusion criteria (4 listed)
- Ages outside of 7-17
- Located outside of the United States of America
- No internet access
- No proficiency in English
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 |
|---|---|---|
| The MapHabit SystemThe MapHabit System (MHS) is a commercially available visual mapping software application that utilize visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). 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. The application was made available to families through compatible smartphones and tablets. The MHS is a general wellness product and there is no regulatory oversight of the MapHabit System mapping functionality. This functionality is not a regulated medical device. | Device | Experimental |
Primary outcome
Change in Adaptive Behavior Assessment System Third Edition (ABAS-3) from Baseline at 4 Weeks
Time frame: Pre-Post: The assessment was administered at the beginning and end of the study's duration (4-week study).
Assessment is used commonly for children with Down syndrome that evaluates conceptual, social, and practical behavioral skills that are significant for day-to-day functioning. The assessment is scored with the General Adaptive Composite (GAC), which summarizes performance across all adaptive skill areas. GAC score ranges from 0-130, with a higher score indicating better outcome.
Quality of Life - 18 (QoL-18)
Time frame: The instrument was administered to the participants after the completion of the study duration (4-week study).
18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-5. A higher number indicates better outcome.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 31796718Boatman F, Golden M, Jin J, Kim Y, Law S, Lu A, Merriam N, Zola S. Assistive technology: Visual mapping combined with mobile software can enhance quality of life and ability to carry out activities of daily living in individuals with impaired memory. Technol Health Care. 2020;28(2):121-128. doi: 10.3233/THC-191980.
- Background: PubMed 34269690Kelleher J, Zola S, Cui X, Chen S, Gerber C, Parker MW, Davis C, Law S, Golden M, Vaughan CP. Personalized Visual Mapping Assistive Technology to Improve Functional Ability in Persons With Dementia: Feasibility Cohort Study. JMIR Aging. 2021 Oct 19;4(4):e28165. doi: 10.2196/28165.
- Background: PubMed 34334439Parker MW, Davis C, White K, Johnson D, Golden M, Zola S. Reduced care burden and improved quality of life in African American family caregivers: Positive impact of personalized assistive technology. Technol Health Care. 2022;30(2):379-387. doi: 10.3233/THC-213049.
- Derived from this study: PubMed 37224142White K, Han SS, Britton A, Hendrix J. A feasibility study demonstrating that independence, quality of life, and adaptive behavioral skills can improve in children with Down syndrome after using assistive technology. PLoS One. 2023 May 24;18(5):e0284738. doi: 10.1371/journal.pone.0284738. eCollection 2023.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Down Syndrome
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. This study is not recruiting at the moment.
Stuart Zola, PhD principal investigator
MapHabit, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The MapHabit System in people with Down Syndrome and Adaptive Behavior, run by MapHabit, Inc. 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adaptive Behavior Assessment System Third Edition (ABAS-3) from Baseline at 4 Weeks (time frame: Pre-Post: The assessment was administered at the beginning and end of the study's duration (4-week study).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05343468, which also lists 4 linked publications.
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 24 Feb 2023.