Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05332912 |
Other study ID # |
19-08-2644 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 1, 2021 |
Est. completion date |
July 1, 2024 |
Study information
Verified date |
December 2023 |
Source |
University of Alabama, Tuscaloosa |
Contact |
Edward C Merrill, Phd |
Phone |
12052002183 |
Email |
emerrill[@]ua.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.