- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05332912
Assessing Malleability of Spatial Abilities in Down Syndrome
Assessing the Malleability of Spatial Abilities in Individuals With Down Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Edward C Merrill, Phd
- Phone Number: 12052002183
- Email: emerrill@ua.edu
Study Locations
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-
Alabama
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Tuscaloosa, Alabama, United States, 35405
- Recruiting
- University of Alabama, Tuscaloosa
-
Contact:
- Edward C Merrill, PhD
- Phone Number: 205-200-2183
- Email: emerrill@ua.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Immediate
Participants will receive 16 weeks of spatial ability experience.
|
Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Placebo Comparator: Delayed
Participants will receive 8 weeks of verbal ability experience prior to receiving 8 weeks of spatial ability experience.
|
Participants will engage in puzzle construction, block play, visual search, hide and seek
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Rotation Ability 1
Time Frame: Pre-test (Day 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.
|
Pre-test (Day 2)
|
Mental Rotation Ability 2
Time Frame: Mid-test (Day 11)
|
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.
|
Mid-test (Day 11)
|
Mental Rotation Ability 3
Time Frame: Post-test (Day 20)
|
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.
|
Post-test (Day 20)
|
Perspective Taking Ability 1
Time Frame: Pre-test (Day 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.
|
Pre-test (Day 2)
|
Perspective Taking Ability 2
Time Frame: Mid-test (Day 11)
|
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.
|
Mid-test (Day 11)
|
Perspective Taking Ability 3
Time Frame: Post-test (Day 20)
|
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.
|
Post-test (Day 20)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-08-2644
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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