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Storybook Reading in Individuals With Down Syndrome

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ClinicalTrials.gov Identifier: NCT03764761
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : December 5, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Krista Wilkinson, Penn State University

Brief Summary:

This study uses mobile eye-tracking technology in order to characterize patterns of visual attention to communication supports, as well as a partner, within real world interactions for individuals with Down syndrome.

Visual communication supports are central components of what is termed augmentative and alternative communication (AAC) intervention. AAC refers to the methods and technology designed to supplement spoken communication for people with limited speech. "Aided" AAC is a subcategory in which an external aid stores and presents for use visual symbols such as photographs, line drawings, or alphabet letters. The most traditional means of structuring aided AAC displays is to present the language concepts within row-column grids, which contain individual symbols/concepts placed in each grid square. The investigator's previous work investigated whether these grid-based presentations could be improved by understanding how different perceptual features of the displays influence responding (i.e., whether what the display looks like influences how easily the information on it is found). Individuals with developmental disabilities and children developing typically were faster and more accurate in finding information on some displays over others, when tested using a "visual search" task (aka, a "finding game" - "find the dog").

The previous investigations have evaluated visual attention within a setting that isolated visual processing of the AAC display as the primary dependent measure. However, communication requires attention not only to an AAC display, but also to a communication partner. Therefore, the current study seeks to examine questions of visual attention to both an AAC display and a communication partner. The investigators will manipulate characteristics of the structure of the display (e.g., arrangement of symbols), in order to determine if more optimal displays facilitate desirable patterns of visual attention to both the communication display and the partner. The mobile eye-tracking technology captures attention to both the display and the communication partner. The investigators anticipate that participants will be able to attend to their partner and the shared activity more when the AAC display is more optimal, but that when the AAC display is sub-optimal, the participants will have to spend more time examining the AAC display and less time in actual communication.


Condition or disease Intervention/treatment Phase
Down Syndrome Augmentative and Alternative Communication Device: AAC Technology - Standard of Care Device: AAC Technology - non-optimal integrated arrangement Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Within subjects alternating treatment design
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Eye Tracking Technologies to Characterize and Optimize Visual Attending in Down Syndrome
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Down Syndrome

Arm Intervention/treatment
Experimental: AAC Intervention
Participants will use AAC technology of different designs delivered on iMacs or Surface tablets
Device: AAC Technology - Standard of Care
Story Book is separate from AAC symbols, AAC symbols are arranged on a grid with color backgrounds. This is non-optimal arrangement and non-integrated presentation
Other Name: Standard of Care

Device: AAC Technology - non-optimal integrated arrangement
Story Book is integrated on to the AAC display together with the AAC symbols, AAC symbols are arranged on a grid with color backgrounds. This is non-optimal arrangement and but integrated presentation
Other Name: Non-optimal, integrated

Device: AAC Technology - non-optimal integrated arrangement
Story Book is integrated on to the AAC display together with the AAC symbols, AAC symbols are arranged on a grid with color backgrounds. This is optimal arrangement and but integrated presentation
Other Name: Optimal, integrated




Primary Outcome Measures :
  1. Percent of visual fixation time on meaningful and non meaningful stimuli [ Time Frame: 1-6 hours ]
    Measured through percent of fixation time allocated to (a) the AAC display; (b) the storybook, or (c) the communication partner. Percent is calculated by dividing the total number of samples within each area (AAC display, storybook, partner) into the total number of samples obtained by the eye tracking device.

  2. Number of times the participant communicates during the intervention [ Time Frame: 1-6 hours ]
    Rate of communication attempts during the storybook reading is defined as the number of times the participant attempts to communicate, divided by the total session duration.



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Ages Eligible for Study:   7 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with Down syndrome who have receptive language age estimates between 3;0 -7;0 years as measures on the Peabody Picture Vocabulary Test- 4th Edition (PPVT-IV; Dunn & Dunn, 2006) and chronological ages of 7 to 35 years.

Exclusion Criteria:

  • We will exclude anyone outside the range of 7-35 years, inclusive. We will plan to exclude those having: (1) uncontrolled seizures; (2) sensory or peripheral impairment that might impair performance; (3) co-morbid illnesses with implications for central nervous system function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764761


Contacts
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Contact: Krista M Wilkinson, PhD 814-863-2206 kmw22@psu.edu

Locations
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United States, Pennsylvania
11 Ford Building Recruiting
University Park, Pennsylvania, United States, 16802
Contact: Krista M Wilkinson, PhD    814-863-2206    kmw22@psu.edu   
Sponsors and Collaborators
Penn State University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Krista Wilkinson, PhD Penn State

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Responsible Party: Krista Wilkinson, Professor, Penn State University
ClinicalTrials.gov Identifier: NCT03764761     History of Changes
Other Study ID Numbers: Storybook
R01HD083381-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Down Syndrome
Syndrome
Disease
Pathologic Processes
Intellectual Disability
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Abnormalities, Multiple
Congenital Abnormalities
Chromosome Disorders
Genetic Diseases, Inborn