Trial Outcomes & Findings for Assessing Malleability of Spatial Abilities in Down Syndrome (NCT NCT05332912)
NCT ID: NCT05332912
Last Updated: 2025-10-14
Results Overview
The Mental Rotation Assessment was used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches out of 18 possible matches over all rotations (excluding 0 degrees) was used as a measure of performance. Minimum score = 0. Maximum score = 18. Higher scores reflect better performance. Change in Mental Rotation Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 2) Assessment scores.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84 participants
Primary outcome timeframe
Following 8 weeks of experience training.
Results posted on
2025-10-14
Participant Flow
Participants self-identified to the researchers by responding to notices placed in various locations, including daycare centers, Children helping science website, Down syndrome organizations (locally and nation-wide), etc. Following contact that included providing details of the project, potential participants who met criteria were sent informed consent documents. Those who returned signed consent documents were identified as enrolled in the study. Dates:
Treatment vs delayed treatment (control) were identified in waves (as control required matching with the treatment group on nonverbal ability). CoVid restrictions at the start of the study and use of remote only testing impacted recruit of individuals with Down syndrome. Hence, all participants with Down Syndrome were assigned to a treatment group to maximize their contribution to the research. Typically developing children served as controls for both groups.
Participant milestones
| Measure |
Typically Developing Children Immediate Intervention
Children Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Typically Developing Children Delayed Intervention
Children Participants received 8 weeks of spatial ability experience that was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Immediate Intervention
Down Syndrome Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Deleayed Intervention
Down Syndrome Participants received 8 weeks of spatial ability experience that was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play,
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
30
|
24
|
30
|
0
|
|
Overall Study
COMPLETED
|
30
|
23
|
27
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
Typically Developing Children Immediate Intervention
Children Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Typically Developing Children Delayed Intervention
Children Participants received 8 weeks of spatial ability experience that was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Immediate Intervention
Down Syndrome Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Deleayed Intervention
Down Syndrome Participants received 8 weeks of spatial ability experience that was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play,
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Assessing Malleability of Spatial Abilities in Down Syndrome
Baseline characteristics by cohort
| Measure |
Typically Developing Children Immediate Intervention
n=30 Participants
Children Participants will receive 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Typically Developing Children Delayed Intervention
n=24 Participants
Children Participants will receive 8 weeks of verbal ability experience prior to receiving 8 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Immediate Intervention
n=30 Participants
Down Syndrome Participants will receive 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Delayed Intervention
Down Syndrome Participants will receive 8 weeks of verbal ability experience prior to receiving 8 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
30 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
—
|
70 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
—
|
14 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
—
|
42 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
—
|
42 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
—
|
15 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
—
|
69 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
—
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
—
|
14 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
—
|
63 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
—
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
24 participants
n=107 Participants
|
30 participants
n=206 Participants
|
—
|
84 participants
n=31 Participants
|
|
Ravens Progressive Matrices 2nd Edition
|
109 Performance Age Equivalence in Months
STANDARD_DEVIATION 39 • n=99 Participants
|
90 Performance Age Equivalence in Months
STANDARD_DEVIATION 30 • n=107 Participants
|
83 Performance Age Equivalence in Months
STANDARD_DEVIATION 35 • n=206 Participants
|
—
|
94 Performance Age Equivalence in Months
STANDARD_DEVIATION 36 • n=31 Participants
|
|
Peabody Picture Vocabulary Test 4th Edition
|
121 Performance Age Equivalence in Months
STANDARD_DEVIATION 50 • n=99 Participants
|
105 Performance Age Equivalence in Months
STANDARD_DEVIATION 37 • n=107 Participants
|
93 Performance Age Equivalence in Months
STANDARD_DEVIATION 24 • n=206 Participants
|
—
|
107 Performance Age Equivalence in Months
STANDARD_DEVIATION 41 • n=31 Participants
|
|
Mental Rotation Ability
|
15.4 Number Correct out of 18
STANDARD_DEVIATION 2.5 • n=99 Participants
|
14.5 Number Correct out of 18
STANDARD_DEVIATION 3.7 • n=107 Participants
|
13.3 Number Correct out of 18
STANDARD_DEVIATION 4.1 • n=206 Participants
|
—
|
14.4 Number Correct out of 18
STANDARD_DEVIATION 4 • n=31 Participants
|
|
Visual Perspective Taking Ability
|
15.9 Number of Total Points out of 24
STANDARD_DEVIATION 6.5 • n=99 Participants
|
13.6 Number of Total Points out of 24
STANDARD_DEVIATION 6.6 • n=107 Participants
|
11.5 Number of Total Points out of 24
STANDARD_DEVIATION 4.5 • n=206 Participants
|
—
|
13.7 Number of Total Points out of 24
STANDARD_DEVIATION 7.2 • n=31 Participants
|
PRIMARY outcome
Timeframe: Following 8 weeks of experience training.Population: No Down Syndrome participants took part in the Delayed Intervention Condition.
The Mental Rotation Assessment was used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches out of 18 possible matches over all rotations (excluding 0 degrees) was used as a measure of performance. Minimum score = 0. Maximum score = 18. Higher scores reflect better performance. Change in Mental Rotation Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 2) Assessment scores.
Outcome measures
| Measure |
Typically Developing Children Immediate Intervention
n=30 Participants
Children Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Typically Developing Children Delayed Intervention
n=23 Participants
Children Participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Immediate Intervention
n=27 Participants
Down Syndrome Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Delayed Intervention
Down Syndrome participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
|---|---|---|---|---|
|
Change in Mental Rotation Ability at 8 Weeks
|
0.0 Amount of Change in Number Correct Items
Standard Deviation 0.8
|
-0.6 Amount of Change in Number Correct Items
Standard Deviation 3.3
|
.82 Amount of Change in Number Correct Items
Standard Deviation 2.8
|
—
|
PRIMARY outcome
Timeframe: Following 16 weeks of experience training.Population: No Down Syndrome participants took part in the Delayed Intervention Condition.
The Mental Rotation Assessment was used to assess ability to match objects rotated at varying degrees from a standard. Number of correct matches out of 18 possible matches over all rotations (excluding 0 degrees) was used as a measure of performance. Minimum score = 0. Maximum score = 18. Higher scores reflect better performance. Change in Mental Rotation Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 3) Assessment scores.
Outcome measures
| Measure |
Typically Developing Children Immediate Intervention
n=30 Participants
Children Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Typically Developing Children Delayed Intervention
n=23 Participants
Children Participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Immediate Intervention
n=27 Participants
Down Syndrome Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Delayed Intervention
Down Syndrome participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
|---|---|---|---|---|
|
Change in Mental Rotation Ability at 16 Weeks
|
1.3 Amount of Change in Number Correct Items
Standard Deviation 2.3
|
1.0 Amount of Change in Number Correct Items
Standard Deviation 2.2
|
0.8 Amount of Change in Number Correct Items
Standard Deviation 2.9
|
—
|
PRIMARY outcome
Timeframe: Following 8 weeks of experience training.Population: No Down Syndrome participants took part in the Delayed Intervention Condition.
Measure Description: Participants received 8 trials in which they judged another's point of view. Scores could range from 0 to 24. . Change in Perspective Taking Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 8 Week (Time 2) Assessment scores.
Outcome measures
| Measure |
Typically Developing Children Immediate Intervention
n=30 Participants
Children Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Typically Developing Children Delayed Intervention
n=23 Participants
Children Participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Immediate Intervention
n=27 Participants
Down Syndrome Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Delayed Intervention
Down Syndrome participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
|---|---|---|---|---|
|
Change in Perspective Taking Ability at 8 Weeks
|
0.9 Change in Performance Points Awarded
Standard Deviation 3.1
|
2.5 Change in Performance Points Awarded
Standard Deviation 4.1
|
1.6 Change in Performance Points Awarded
Standard Deviation 4.0
|
—
|
PRIMARY outcome
Timeframe: Following 16 weeks of experience training.Population: No Down Syndrome participants took part in the Delayed Intervention Condition.
Participants received 8 trials in which they judged another's point of view. Scores could range from 0 to 24. Change in Perspective Taking Ability was calculated by subtracting Baseline (Time 1) Assessment scores from 16 Week (Time 3) Assessment scores.
Outcome measures
| Measure |
Typically Developing Children Immediate Intervention
n=30 Participants
Children Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Typically Developing Children Delayed Intervention
n=23 Participants
Children Participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Immediate Intervention
n=27 Participants
Down Syndrome Participants received 16 weeks of spatial ability experience.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
Down Syndrome Participants Delayed Intervention
Down Syndrome participants received 8 weeks of spatial ability experience. Experience training was initiated eight weeks following the initial assessment (no intervening task) and immediately following the second assessment.
Spatial Ability Experience: Participants will engage in puzzle construction, block play, visual search, hide and seek
|
|---|---|---|---|---|
|
Change in Perspective Taking Ability at 16 Weeks
|
1.0 Change in Performance Points Awarded
Standard Deviation 3.7
|
1.6 Change in Performance Points Awarded
Standard Deviation 5.1
|
2.4 Change in Performance Points Awarded
Standard Deviation 5.1
|
—
|
Adverse Events
Typically Developing Children Immediate Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Typically Developing Children Deleayed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Down Syndrome Participants Immediate Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Down Syndrome Participants Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place