Life Skills Improved in Children With Down Syndrome After Using Assistive Technology

Quality of Life Clinical Trial

Official title:

Independence, Quality of Life, and Adaptive Behavioral Skills Improved in Children With Down Syndrome After Using Assistive Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05343468
• Other study ID #: LuMind Study
• Secondary ID: 5R43AG065081-02
• Status: Completed
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: August 5, 2021

Study information

• Verified date: February 2023
• Source: MapHabit, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 5, 2021
• Est. primary completion date: June 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Quality of Life
• Syndrome

Intervention

Device:
• The MapHabit System
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.

Locations

Country	Name	City	State
United States	MapHabit, Inc.	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
MapHabit, Inc.	LuMind IDSC Foundation, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-Post: The assessment was administered at the beginning and end of the study's duration (4-week study).
Primary	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.	The instrument was administered to the participants after the completion of the study duration (4-week study).