Storybook Reading in Individuals With Down Syndrome

NCT03764761 | Terminated FDA Device

• 2 other identifiers: StorybookR01HD083381-01A1
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Augmentative and Alternative Communication

Outcome Measures

Primary Outcomes (2)

• Percent of visual fixation time on meaningful and non meaningful stimuli

  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.

  1-6 hours

• Number of times the participant communicates during the intervention

  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.

  1-6 hours

Study Arms (1)

AAC Intervention

EXPERIMENTAL

Participants will use AAC technology of different designs delivered on iMacs or Surface tablets

Device: AAC Technology - Standard of Care; Device: AAC Technology - non-optimal integrated arrangement

Interventions

AAC Technology - Standard of Care DEVICE

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

Also known as: Standard of Care

AAC Intervention

AAC Technology - non-optimal integrated arrangement DEVICE

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

Also known as: Non-optimal, integrated

AAC Intervention

Eligibility Criteria

• Age: 7 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Penn State University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

11 Ford Building

University Park, Pennsylvania, 16802, United States

Location

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

• Krista Wilkinson, PhD

  Penn State

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Within subjects alternating treatment design

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: December 5, 2018
• Study Start: April 1, 2018
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)