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

NCT ID: NCT05343468

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2021-08-05

Brief Summary

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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.

Detailed Description

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Conditions

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Down Syndrome Adaptive Behavior Quality of Life

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental

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

Group Type EXPERIMENTAL

The MapHabit System

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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LuMind IDSC Foundation

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

MapHabit, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Stuart Zola

Chief Scientific Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuart Zola, PhD

Role: PRINCIPAL_INVESTIGATOR

MapHabit, Inc.

Locations

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MapHabit, Inc.

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31796718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34269690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34334439 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37224142 (View on PubMed)

Other Identifiers

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5R43AG065081-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

LuMind Study

Identifier Type: -

Identifier Source: org_study_id

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