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Assessing Malleability of Spatial Abilities in Down Syndrome

Primary Purpose

Down Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spatial Ability Experience
Sponsored by
University of Alabama, Tuscaloosa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Down Syndrome

Eligibility Criteria

4 Years - 25 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Typically Developing Children ages 4.0 years to 9.0 years
  • Individuals with Down Syndrome ages 10.0 - 25.0
  • Verbal Comprehension Ability at 4.0 years or above

Exclusion Criteria:

  • Inability to follow verbal instructions
  • Inability of use tablet computer

Sites / Locations

  • University of Alabama, TuscaloosaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Immediate

Delayed

Arm Description

Participants will receive 16 weeks of spatial ability experience.

Participants will receive 8 weeks of verbal ability experience prior to receiving 8 weeks of spatial ability experience.

Outcomes

Primary Outcome Measures

Mental Rotation Ability 1
The Mental Rotation Assessment will be used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches at each rotation will be used as a measure of performance.
Mental Rotation Ability 2
The Mental Rotation Assessment will be used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches at each rotation will be used as a measure of performance.
Mental Rotation Ability 3
The Mental Rotation Assessment will be used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches at each rotation will be used as a measure of performance.
Perspective Taking Ability 1
The Perspective Taking Assessment will be used to assess participants ability to mentally assume a visual perspective from a different location in the environment (from a different seat around the table). More specifically, they will be asked to select a picture that represents a view from four different locations around a table. Number of correct choices will be used as our measure of performance.
Perspective Taking Ability 2
The Perspective Taking Assessment will be used to assess participants ability to mentally assume a visual perspective from a different location in the environment (from a different seat around the table). More specifically, they will be asked to select a picture that represents a view from four different locations around a table. Number of correct choices will be used as our measure of performance.
Perspective Taking Ability 3
The Perspective Taking Assessment will be used to assess participants ability to mentally assume a visual perspective from a different location in the environment (from a different seat around the table). More specifically, they will be asked to select a picture that represents a view from four different locations around a table. Number of correct choices will be used as our measure of performance.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2022
Last Updated
April 10, 2022
Sponsor
University of Alabama, Tuscaloosa
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1. Study Identification

Unique Protocol Identification Number
NCT05332912
Brief Title
Assessing Malleability of Spatial Abilities in Down Syndrome
Official Title
Assessing the Malleability of Spatial Abilities in Individuals With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama, Tuscaloosa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Based on available literature and our own preliminary research, the researchers have concluded that persons with Down syndrome (DS) exhibit difficulties in utilizing the specific spatial abilities of mental rotation and perspective taking and performing complex spatial tasks such as wayfinding and environmental learning. A weakness in spatial abilities may have many direct applications to daily life, ranging from activities such as tying shoes to using hand tools and navigating the environment. Spatial abilities also serve as a cognitive foundation for many other complex skills such as solving mathematical problems and using spatial language for giving and receiving directions. Moreover, spatial abilities are used in a variety of specialty jobs such as grocery stocking, packaging, and assembling, which are among the most commonly reported jobs for adults with DS. Hence, a new focus on spatial ability and its modifiability in persons with DS is clearly warranted. The primary goal of the research proposed in this application is to evaluate the malleability of mental rotation and perspective taking in people with DS through providing intentional experience with numerous spatial activities. Two groups of participants will be tested over the course of the project: adolescents and young adults with DS and typically developing (TD) children. Following an initial evaluation of performance on the two abilities, participants will receive up to eight sessions of spatial activity experience utilizing puzzle construction, block building, and computer search tasks. Following the experience sessions, spatial abilities of participants will be re-evaluated. These data will be used to investigate two specific aims. First, the researchers investigate whether spatial abilities of persons with DS can be modified by experience with spatial activities. Second, the researchers investigate whether the degree of modification observed for persons with DS can reduce performance differences between them and TD children. The researchers also consider whether performance on the PPVT, Raven's matrices, and Chronological Age are associated with any benefits from spatial ability experience.
Detailed Description
Participants will take part in a study designed to facilitate the development of two spatial abilities: Mental Rotation and Visual Perspective Taking. Mental rotation reflects the ability to mentally manipulate a small object without physically rotating it. Perspective taking reflects the ability to imagine what a large environment would look like from a different position. Both abilities are important for engaging in everyday spatial activities such as navigating the environment without getting lost. The researchers have constructed four tasks to provide experience with these two abilities over the course of approximately four months. There will be an initial assessment (one week), followed by eight weeks of experiences using four different spatial ability games, a second assessment, eight more weeks of experience, and then a third assessment. The initial assessment will include four measures: Ravens 2 Matrices: The Ravens 2 Matrices is a 60-item measure of nonverbal ability. The subtest measures a participant's ability to solve problems, identify relationships, and complete visual analogies without testing language skill. The examiner shows the participant pictures or abstract designs that follow a pattern, with one element missing. The participant is instructed to point to a picture that will complete the pattern. Participants will be matched on raw score performance. Completing the subtest should take less than 15 minutes for most participants. Peabody Picture Vocabulary Test (PPVT) - 4: The PPVT - 4 is a norm-referenced test for measuring receptive vocabulary of children and adults. The test is administered individually. Each item consists of four colored pictures that serve as response choices on each page. For each item, the examiner says a word and the examinee selects the picture option that best represents the word's meaning. The test is normed for 2 years, 6 months to 90 years. Average time to administer the test is 10 - 15 minutes. Mental Rotation Assessment - On each trial, participants will be presented a geometric shape (e.g., a block letter L) in the center of a computer screen that completes one of two rectangles presented at the bottom of the same screen. The open area in one rectangle is the mirror image of the open area in the second rectangle. The shape in the center of the screen will fit one of the rectangles when horizontal. The shape can be rotated from horizontal by 0, 45, 90, 135, 180, 225, 270, or 315 degrees. Participants respond by touching the rectangle into which the shape will fit once oriented properly (using touchscreen technology). Participants receive 4 trials at each orientation. Perspective Taking - Participants will be seated at a table with four chairs and four different objects (street light, mailbox, stop sign, traffic signal) representing each location on the corner of a city block in front of each chair. A stuffed animal is placed behind each object. One experimenter walks around the table stopping at each location. At each location, the participant is told that the experimenter is taking a picture from that location and the participant is asked to look at four pictures. The task is to select the picture that the experimenter has just taken. The four pictures consist of the participant's point of view, a mirror image of the participant's point of view, the experimenter's point of view, and a mirror image of the experimenter's point of view. This task will take 5 - 10 minutes. Assessments 2 and 3 will include only Mental Rotation and Perspective Taking Assessments. Spatial Ability Experience will include two tasks of Object manipulation and two Large Environment Experiences. These tasks are meant to provide experience. Object Manipulation Experience: Two categories of tasks will be used to provide object manipulation experience: LEGO Block Play and Puzzle Construction. One task will be used in each spatial ability experience, with tasks alternating between sessions. LEGO Block Play: Participants and experimenter will each have 20 multi-colored and multi-shaped connecting blocks. During play, the participant and experimenter will alternate creating structures and copying what the other has created during the 15-minute interval. No specific corrective feedback will be given during the experience, although participants will be asked if the construction matches the model. Object manipulation rather than accuracy is the basis of the experience. Participants will be allowed to take as long as needed to complete their copy of each structure. Puzzle Construction: The researchers will select puzzles that include 4, 8, 12, 16, or 20 puzzle pieces. All puzzles will have pieces that need to be rotated to fit the puzzle board to provide the necessary object manipulation experience. The puzzle board will also include the outline of the shapes of the pieces. Hence, participants will need to match the outline of the piece with the rotated actual piece to efficiently complete the puzzle. Touching each piece with a finger will rotate the piece and removing the finger will stop the rotation. Participants will be given five puzzles to complete during the experience session. The participant will be given 3 minutes to complete each puzzle. If the participant completes the puzzle, the next larger size puzzle will be used for the participant's next opportunity. If the participant fails to complete the puzzle, the size of the puzzle will be reduced by one level. Large Environment Experience: Two categories of tasks using a large-scale virtual environment will be used to provide object manipulation experience: Hide and Seek and Wayfinding. One task will be used in each spatial ability experience, with tasks alternating between sessions. Hide and Seek Video Game: The setting will consist of a classroom with four different color doorways. The participant will be identified as an avatar (self-selected) in the center of the classroom. A second avatar will represent a person hiding behind one of the doors. The doors will be described as "see through" from the perspective of the hiding avatar. The participant will be shown a panoramic view of the classroom. Then he or she will be shown the view from the hiding avatar. The view will return as the point of view of the participant avatar and the participant will be instructed to find the door that the second avatar is hiding behind. The participant will be allowed to look behind any door to find the hiding avatar. If the participant selects the wrong door, the participant will be shown the view of the hiding avatar again and asked to continue the search. Once found, the avatar will be placed behind a second door and the procedure will be repeated. There will be four trails per session. The experimenter will record the number of wrong locations that were searched and the time to find the hiding avatar for each search event. Time for this task will be approximately 15 minutes. Wayfinding Video Game: Children will be exposed to a scene using Google street view and asked to search for specific targets that can be scene along the path. In order to complete the task, the participant will need to be able to identify the targets from different perspectives. Children who are assigned to the Control condition will receive the spatial ability experiences following an eight-week delay after the initial assessment. The control participant will receive verbal ability experiences (story telling, verbal fluency games, memory games) during the eight-week delay.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Typically developing children will be compared to adolescents/young adults with Down syndrome (groups matched on non-verbal ability). A delayed start condition (verbal experience instead of spatial ability experience) of eight weeks will be used for 1/2 of participants in each group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate
Arm Type
Experimental
Arm Description
Participants will receive 16 weeks of spatial ability experience.
Arm Title
Delayed
Arm Type
Placebo Comparator
Arm Description
Participants will receive 8 weeks of verbal ability experience prior to receiving 8 weeks of spatial ability experience.
Intervention Type
Behavioral
Intervention Name(s)
Spatial Ability Experience
Intervention Description
Participants will engage in puzzle construction, block play, visual search, hide and seek
Primary Outcome Measure Information:
Title
Mental Rotation Ability 1
Description
The Mental Rotation Assessment will be used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches at each rotation will be used as a measure of performance.
Time Frame
Pre-test (Day 2)
Title
Mental Rotation Ability 2
Description
The Mental Rotation Assessment will be used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches at each rotation will be used as a measure of performance.
Time Frame
Mid-test (Day 11)
Title
Mental Rotation Ability 3
Description
The Mental Rotation Assessment will be used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches at each rotation will be used as a measure of performance.
Time Frame
Post-test (Day 20)
Title
Perspective Taking Ability 1
Description
The Perspective Taking Assessment will be used to assess participants ability to mentally assume a visual perspective from a different location in the environment (from a different seat around the table). More specifically, they will be asked to select a picture that represents a view from four different locations around a table. Number of correct choices will be used as our measure of performance.
Time Frame
Pre-test (Day 2)
Title
Perspective Taking Ability 2
Description
The Perspective Taking Assessment will be used to assess participants ability to mentally assume a visual perspective from a different location in the environment (from a different seat around the table). More specifically, they will be asked to select a picture that represents a view from four different locations around a table. Number of correct choices will be used as our measure of performance.
Time Frame
Mid-test (Day 11)
Title
Perspective Taking Ability 3
Description
The Perspective Taking Assessment will be used to assess participants ability to mentally assume a visual perspective from a different location in the environment (from a different seat around the table). More specifically, they will be asked to select a picture that represents a view from four different locations around a table. Number of correct choices will be used as our measure of performance.
Time Frame
Post-test (Day 20)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Typically Developing Children ages 4.0 years to 9.0 years Individuals with Down Syndrome ages 10.0 - 25.0 Verbal Comprehension Ability at 4.0 years or above Exclusion Criteria: Inability to follow verbal instructions Inability of use tablet computer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Edward C Merrill, Phd
Phone
12052002183
Email
emerrill@ua.edu
Facility Information:
Facility Name
University of Alabama, Tuscaloosa
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edward C Merrill, PhD
Phone
205-200-2183
Email
emerrill@ua.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual Participant Data (IPD) will be available upon request after the study is completed, data has been analyzed, and the primary data has been published or within 5 years of study completion if data has not been published. Requests can be made to the PI.
IPD Sharing Time Frame
Data will be available following publication of the primary data or within 5 years of study completion if data has not been published. Data will be available for a minimum of 5 years.
IPD Sharing Access Criteria
Requests will be accepted from behavioral researchers with a PhD or equivalent who identify a specific purpose and research appropriate justification for accessing the IPD. Requests will be reviewed by the PI and the sub-contract PI.

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Assessing Malleability of Spatial Abilities in Down Syndrome

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