Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
Primary Purpose
Down Syndrome, Adaptive Behavior, Quality of Life
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The MapHabit System
Sponsored by
About this trial
This is an interventional supportive care trial for Down Syndrome focused on measuring Down syndrome, Assistive technology, Adaptive behavioral skills
Eligibility Criteria
Inclusion Criteria:
- Down syndrome diagnosis
- Age between 7-17
- Internet access
- Proficiency in English
Exclusion Criteria:
- Ages outside of 7-17
- Located outside of the United States of America
- No internet access
- No proficiency in English
Sites / Locations
- MapHabit, Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Singe-arm: the assistive digital software was implemented as an intervention to all participants.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05343468
First Posted
April 5, 2022
Last Updated
February 22, 2023
Sponsor
MapHabit, Inc.
Collaborators
LuMind IDSC Foundation, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05343468
Brief Title
Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
Official Title
Independence, Quality of Life, and Adaptive Behavioral Skills Improved in Children With Down Syndrome After Using Assistive Technology
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
August 5, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MapHabit, Inc.
Collaborators
LuMind IDSC Foundation, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome, Adaptive Behavior, Quality of Life
Keywords
Down syndrome, Assistive technology, Adaptive behavioral skills
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Singe-arm: the assistive digital software was implemented as an intervention to all participants.
Intervention Type
Device
Intervention Name(s)
The MapHabit System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Adaptive Behavior Assessment System Third Edition (ABAS-3) from Baseline at 4 Weeks
Description
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.
Time Frame
Pre-Post: The assessment was administered at the beginning and end of the study's duration (4-week study).
Title
Quality of Life - 18 (QoL-18)
Description
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.
Time Frame
The instrument was administered to the participants after the completion of the study duration (4-week study).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Down syndrome diagnosis
Age between 7-17
Internet access
Proficiency in English
Exclusion Criteria:
Ages outside of 7-17
Located outside of the United States of America
No internet access
No proficiency in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Zola, PhD
Organizational Affiliation
MapHabit, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
MapHabit, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to szola@maphabit.com. To gain access, data requestors will need to sign a data access agreement.
Citations:
PubMed Identifier
31796718
Citation
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.
Results Reference
background
PubMed Identifier
34269690
Citation
Kelleher 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.
Results Reference
background
PubMed Identifier
34334439
Citation
Parker 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.
Results Reference
background
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Life Skills Improved in Children With Down Syndrome After Using Assistive Technology
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