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

NCT05343468 | Completed

• 2 other identifiers: LuMind Study5R43AG065081-02
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Adaptive Behavior; Quality of Life

Keywords

Down syndrome; Assistive technology; Adaptive behavioral skills

Outcome Measures

Primary Outcomes (2)

• 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).

• 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).

Study Arms (1)

Experimental

EXPERIMENTAL

Singe-arm: the assistive digital software was implemented as an intervention to all participants.

Device: The MapHabit System

Interventions

The MapHabit System DEVICE

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.

Experimental

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Down syndrome diagnosis
• Age between 7-17
• Internet access
• Proficiency in English

You may not qualify if:

• Ages outside of 7-17
• Located outside of the United States of America
• No internet access
• No proficiency in English

Sponsors & Collaborators

• MapHabit, Inc.: lead
• LuMind IDSC Foundation: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

MapHabit, Inc.

Atlanta, Georgia, 30308, United States

Location

Related Publications (4)

• 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.

  PMID: 31796718 BACKGROUND

• 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.

  PMID: 34269690 BACKGROUND

• 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.

  PMID: 34334439 BACKGROUND

• White 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.

  PMID: 37224142 DERIVED

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Stuart Zola, PhD

  MapHabit, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 25, 2022
• Study Start: September 20, 2020
• Primary Completion: June 18, 2021
• Study Completion: August 5, 2021
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)