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OpenTrials
Completed

NCT Number: NCT05343468

Life 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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Adaptive Behavior Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Quality of Life

Age range

7 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MapHabit, Inc.

Atlanta, Georgia, 30308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

MapHabit, Inc.

Industry

Collaborators

  • LuMind IDSC Foundation
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2022
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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