Trial Outcomes & Findings for Flexible Attention to Magnitudes and Early Math (NCT NCT05682729)

NCT ID: NCT05682729

Last Updated: 2025-10-30

Results Overview

Assesses preschool-aged children's ability to flexibly shift between attending to numerical and spatial magnitudes. The task is scored for accuracy (0 - 1), and higher scores indicate better outcomes. The outcome measure was change in accuracy from baseline to immediately after intervention, or 4 days.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

116 participants

Primary outcome timeframe

Baseline and after intervention (up to 4 days)

Results posted on

2025-10-30

Participant Flow

We initially recruited 169 participants for the study, knowing that school absences during a short-term weeklong study would likely significantly reduce the final sample size. Participant exclusions were primarily due to school absences (n = 28), children not wanting to participate in one or more assessments (n = 13), developmental delays (n = 1), and technical errors with the online data collection system (n = 11).

Participant milestones

Participant milestones
Measure
Size to Number
Book Reading Intervention: Children read books containing relevant stimuli.
Mixed
Book Reading Intervention: Children read books containing relevant stimuli.
Traditional Counting
Book Reading Intervention: Children read books containing relevant stimuli.
Non-Numerical Control
Book Reading Intervention: Children read books containing relevant stimuli.
Overall Study
STARTED
37
25
30
24
Overall Study
COMPLETED
37
25
30
24
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Flexible Attention to Magnitudes and Early Math

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Size to Number
n=37 Participants
Book Reading Intervention: Children read books containing relevant stimuli.
Mixed
n=25 Participants
Book Reading Intervention: Children read books containing relevant stimuli.
Traditional Counting
n=30 Participants
Book Reading Intervention: Children read books containing relevant stimuli.
Non-Numerical Control
n=24 Participants
Book Reading Intervention: Children read books containing relevant stimuli.
Total
n=116 Participants
Total of all reporting groups
Age, Continuous
55 Months of age
STANDARD_DEVIATION 8 • n=5 Participants
55 Months of age
STANDARD_DEVIATION 8 • n=7 Participants
56 Months of age
STANDARD_DEVIATION 8 • n=5 Participants
56 Months of age
STANDARD_DEVIATION 8 • n=4 Participants
56 Months of age
STANDARD_DEVIATION 8 • n=21 Participants
Sex: Female, Male
Female
17 Participants
n=5 Participants
14 Participants
n=7 Participants
16 Participants
n=5 Participants
16 Participants
n=4 Participants
63 Participants
n=21 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
11 Participants
n=7 Participants
14 Participants
n=5 Participants
8 Participants
n=4 Participants
53 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=5 Participants
0 Participants
n=7 Participants
4 Participants
n=5 Participants
5 Participants
n=4 Participants
10 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants
n=5 Participants
21 Participants
n=7 Participants
23 Participants
n=5 Participants
17 Participants
n=4 Participants
92 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants
n=5 Participants
4 Participants
n=7 Participants
3 Participants
n=5 Participants
2 Participants
n=4 Participants
14 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=5 Participants
9 Participants
n=7 Participants
5 Participants
n=5 Participants
8 Participants
n=4 Participants
32 Participants
n=21 Participants
Race (NIH/OMB)
White
18 Participants
n=5 Participants
9 Participants
n=7 Participants
14 Participants
n=5 Participants
7 Participants
n=4 Participants
48 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
3 Participants
n=7 Participants
5 Participants
n=5 Participants
7 Participants
n=4 Participants
18 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants
n=5 Participants
4 Participants
n=7 Participants
6 Participants
n=5 Participants
2 Participants
n=4 Participants
18 Participants
n=21 Participants
Region of Enrollment
United States
37 participants
n=5 Participants
25 participants
n=7 Participants
30 participants
n=5 Participants
24 participants
n=4 Participants
116 participants
n=21 Participants

PRIMARY outcome

Timeframe: Baseline and after intervention (up to 4 days)

Population: The population was children who completed baseline and post-intervention assessment.

Assesses preschool-aged children's ability to flexibly shift between attending to numerical and spatial magnitudes. The task is scored for accuracy (0 - 1), and higher scores indicate better outcomes. The outcome measure was change in accuracy from baseline to immediately after intervention, or 4 days.

Outcome measures

Outcome measures
Measure
Size to Number
n=37 Participants
Children read books that contained questions about spatial magnitude comparisons followed by questions about numerical magnitude comparisons.
Mixed
n=25 Participants
Children read books that contained questions about spatial and numerical magnitude comparisons that were intermixed throughout the books.
Traditional Counting
n=30 Participants
Children read books that focused on counting.
Non-Numerical Control
n=24 Participants
Children read books with questions about shapes and colors.
Change in Flexible Attention to Magnitudes Task
.07 mean pre-post diff in units on a scale
Standard Deviation .17
.13 mean pre-post diff in units on a scale
Standard Deviation .23
.03 mean pre-post diff in units on a scale
Standard Deviation .26
.08 mean pre-post diff in units on a scale
Standard Deviation .23

SECONDARY outcome

Timeframe: baseline and immediately after intervention (up to 4 days)

Population: The population was children who completed baseline and post-intervention assessment.

Ipad based card game assessing attention shifting. Standardized scores are calculated, with a mean of 100 and a standard deviation of 15. The mean change in standard score from pre-to-post test was examined across all 4 groups.

Outcome measures

Outcome measures
Measure
Size to Number
n=37 Participants
Children read books that contained questions about spatial magnitude comparisons followed by questions about numerical magnitude comparisons.
Mixed
n=25 Participants
Children read books that contained questions about spatial and numerical magnitude comparisons that were intermixed throughout the books.
Traditional Counting
n=30 Participants
Children read books that focused on counting.
Non-Numerical Control
n=24 Participants
Children read books with questions about shapes and colors.
Change in Minnesota Executive Function Scale
-.51 mean pre-post diff on score on a scale
Standard Deviation 7.36
1.12 mean pre-post diff on score on a scale
Standard Deviation 5.19
-1.2 mean pre-post diff on score on a scale
Standard Deviation 10.21
3.96 mean pre-post diff on score on a scale
Standard Deviation 7.36

SECONDARY outcome

Timeframe: baseline and immediately after (up to 4 days)

Population: The population was children who completed baseline and post-intervention assessment.

Child identifies location of a number on a 0 - 10 number line. Total scores range from 0 - 20, with higher scores indicating better performance. Pre-to-post test change scores were examined.

Outcome measures

Outcome measures
Measure
Size to Number
n=37 Participants
Children read books that contained questions about spatial magnitude comparisons followed by questions about numerical magnitude comparisons.
Mixed
n=25 Participants
Children read books that contained questions about spatial and numerical magnitude comparisons that were intermixed throughout the books.
Traditional Counting
n=30 Participants
Children read books that focused on counting.
Non-Numerical Control
n=24 Participants
Children read books with questions about shapes and colors.
Change in Number Line Estimation Task
.51 Mean pre-post diff on score on a scale
Standard Deviation 1.68
.32 Mean pre-post diff on score on a scale
Standard Deviation 1.49
-.17 Mean pre-post diff on score on a scale
Standard Deviation 1.78
-.38 Mean pre-post diff on score on a scale
Standard Deviation 1.53

Adverse Events

Size to Number

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Mixed

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Traditional Counting

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Non-Numerical Control

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

Mary Wagner

University of Dayton

Phone: 9372292775

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place