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Flexible Attention to Magnitudes and Early Math

The Early Development of Flexible Attention to Numerical and Spatial Magnitudes: Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05682729
Acronym
FAM
Enrollment
116
Registered
2023-01-12
Start date
2022-09-01
Completion date
2023-06-30
Last updated
2025-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mathematics Abilities

Brief summary

The goal of this clinical trial is to test the malleability of preschool-aged children's flexible attention to numerical and spatial magnitudes. The main questions it aims to answer are: Does a flexible attention to magnitudes intervention improve young children's math abilities in the area of flexible attention to magnitudes as well as executive functioning and number line estimation skills? Does this intervention improve young children's math abilities more than a traditional counting intervention? Does the method of flexible attention to magnitudes intervention affect how much children improve in their math abilities? Participants will complete a pre-test and post-test in their math abilities and three intervention sessions with a trained experimenter. Each intervention session will involve reading researcher-created books with one-on-one with children for about 20 minutes. Children will be assigned to one of four intervention conditions: * Size to Number Intervention Condition * Size and Number Mixed Intervention Condition * Traditional Counting Intervention * Non-Numerical Control Intervention

Detailed description

This experiment will test the following hypothesis: Children's flexible attention to magnitudes (FAM) ability is malleable and can be developed through innovative interventions. The experiment will include a clinical trial to assess the feasibility of a future clinical intervention to improve children's FAM ability for children at-risk for math difficulties. Participants. Using results from recent number book interventions (ηp2 = .094; Gibson, Gunderson, & Levine, under review), an estimated sample size of 116 preschool-aged children (3 - 5 years old), or 29 children per group, will be recruited. An additional 8 participants will be recruited to account for any possible attrition during the course of the experiment. Method and Analyses. Children will be randomly assigned to one of 4 conditions: Size to Number condition, Mixed condition, or one of two control conditions - a Traditional Counting condition or an Non-Numerical Control condition. In each condition, children will complete a pre-test, followed by three intervention sessions with an experimenter, then a post-test. All assessments and intervention sessions will be completed in a one-on-one setting with an experimenter in a quiet area of the child's childcare center or school. Each condition will involve playing a game on a tablet with an experimenter, and the premise of each game will be children going to the zoo. All stimuli for conditions will be created by the University of Dayton computer engineering students in their research and design course. The stimuli for the Size to Number and Mixed conditions will be identical where all trials are incongruent with respect to numerical and spatial magnitudes across sets, but the ordering of instructions and item presentation will differ. In the Size to Number condition, children will view two sets of animals, each enclosed by a box, and will be asked to indicate which set has bigger animals. Children will then switch to a condition in which they are asked to switch and indicate which set has more animals, with 10 trials for both the number and size conditions. Children will receive feedback on each trial. In the Mixed condition, children will receive 20 trials in which size and number trials are intermixed. In the Traditional Counting condition, children will only see congruent numerical and spatial magnitudes, in other words, sets where the object set with more items will also have larger items and the set with fewer items will also have smaller items. Children will be asked to compare these sets, and feedback will be given. Finally, in the Non-Numerical Control condition, children will see various animals on each trial and will be asked to give the animal's name and sound. An ANCOVA will be used to analyze participant data, with the 4 conditions as the between-subjects variable, and covariates will include children's pre-test, age, gender, and language. The investigator expects to find that both the Size to Number and Mixed conditions will produce higher FAM post-test scores compared to the Traditional Counting and Non-Numerical Control conditions, but do not have a specific prediction as to whether or not the Size to Number or Mixed conditions will outperform one another. The assessments administered at pre- and post-test will include the FAM task, and the investigator will also explore possible transfer effects to children's executive functioning skills and their number line estimation abilities.

Interventions

Children read books containing relevant stimuli.

Sponsors

University of Dayton
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 5 Years
Healthy volunteers
Yes

Inclusion criteria

* Child ages 3 - 5

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Change in Flexible Attention to Magnitudes TaskBaseline and after intervention (up to 4 days)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.

Secondary

MeasureTime frameDescription
Change in Minnesota Executive Function Scalebaseline and immediately after intervention (up to 4 days)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.
Change in Number Line Estimation Taskbaseline and immediately after (up to 4 days)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.

Countries

United States

Participant flow

Pre-assignment details

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).

Participants by arm

ArmCount
Size to Number
Book Reading Intervention: Children read books containing relevant stimuli.
37
Mixed
Book Reading Intervention: Children read books containing relevant stimuli.
25
Traditional Counting
Book Reading Intervention: Children read books containing relevant stimuli.
30
Non-Numerical Control
Book Reading Intervention: Children read books containing relevant stimuli.
24
Total116

Baseline characteristics

CharacteristicSize to NumberTotalNon-Numerical ControlTraditional CountingMixed
Age, Continuous55 Months of age
STANDARD_DEVIATION 8
56 Months of age
STANDARD_DEVIATION 8
56 Months of age
STANDARD_DEVIATION 8
56 Months of age
STANDARD_DEVIATION 8
55 Months of age
STANDARD_DEVIATION 8
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants10 Participants5 Participants4 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
31 Participants92 Participants17 Participants23 Participants21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants14 Participants2 Participants3 Participants4 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
10 Participants32 Participants8 Participants5 Participants9 Participants
Race (NIH/OMB)
More than one race
3 Participants18 Participants7 Participants5 Participants3 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
6 Participants18 Participants2 Participants6 Participants4 Participants
Race (NIH/OMB)
White
18 Participants48 Participants7 Participants14 Participants9 Participants
Region of Enrollment
United States
37 participants116 participants24 participants30 participants25 participants
Sex: Female, Male
Female
17 Participants63 Participants16 Participants16 Participants14 Participants
Sex: Female, Male
Male
20 Participants53 Participants8 Participants14 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 370 / 250 / 300 / 24
other
Total, other adverse events
0 / 370 / 250 / 300 / 24
serious
Total, serious adverse events
0 / 370 / 250 / 300 / 24

Outcome results

Primary

Change in Flexible Attention to Magnitudes Task

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.

Time frame: Baseline and after intervention (up to 4 days)

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

ArmMeasureValue (MEAN)Dispersion
Size to NumberChange in Flexible Attention to Magnitudes Task.07 mean pre-post diff in units on a scaleStandard Deviation 0.17
MixedChange in Flexible Attention to Magnitudes Task.13 mean pre-post diff in units on a scaleStandard Deviation 0.23
Traditional CountingChange in Flexible Attention to Magnitudes Task.03 mean pre-post diff in units on a scaleStandard Deviation 0.26
Non-Numerical ControlChange in Flexible Attention to Magnitudes Task.08 mean pre-post diff in units on a scaleStandard Deviation 0.23
Comparison: We specifically compared the pre-to-post test change in accuracy on the FAM task across the four groups using a within-subjects ANCOVA and specifically a group by time (pre-to-post test) interaction. We controlled for age, gender, and children's executive function skills.p-value: 0.41ANCOVA
Comparison: Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.p-value: 0.004ANCOVA
Comparison: Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.p-value: 0.031ANCOVA
Comparison: Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.p-value: 0.463ANCOVA
Comparison: Following the omnibus test, we conducted planned comparisons to compare pre-to-post test change within our experimental and control groups to test for significant positive change from pre-to-post test.p-value: 0.186ANCOVA
Secondary

Change in Minnesota Executive Function Scale

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.

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

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

ArmMeasureValue (MEAN)Dispersion
Size to NumberChange in Minnesota Executive Function Scale-.51 mean pre-post diff on score on a scaleStandard Deviation 7.36
MixedChange in Minnesota Executive Function Scale1.12 mean pre-post diff on score on a scaleStandard Deviation 5.19
Traditional CountingChange in Minnesota Executive Function Scale-1.2 mean pre-post diff on score on a scaleStandard Deviation 10.21
Non-Numerical ControlChange in Minnesota Executive Function Scale3.96 mean pre-post diff on score on a scaleStandard Deviation 7.36
p-value: 0.605ANCOVA
Secondary

Change in Number Line Estimation Task

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.

Time frame: baseline and immediately after (up to 4 days)

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

ArmMeasureValue (MEAN)Dispersion
Size to NumberChange in Number Line Estimation Task.51 Mean pre-post diff on score on a scaleStandard Deviation 1.68
MixedChange in Number Line Estimation Task.32 Mean pre-post diff on score on a scaleStandard Deviation 1.49
Traditional CountingChange in Number Line Estimation Task-.17 Mean pre-post diff on score on a scaleStandard Deviation 1.78
Non-Numerical ControlChange in Number Line Estimation Task-.38 Mean pre-post diff on score on a scaleStandard Deviation 1.53
p-value: 0.618ANCOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026