- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05682729
Flexible Attention to Magnitudes and Early Math (FAM)
The Early Development of Flexible Attention to Numerical and Spatial Magnitudes: Clinical Trial
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Dayton, Ohio, United States, 45469
- Early Childhood Education Facilities
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Child ages 3 - 5
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Size to Number
|
Children read books containing relevant stimuli.
|
|
Experimental: Mixed
|
Children read books containing relevant stimuli.
|
|
Active Comparator: Traditional Counting
|
Children read books containing relevant stimuli.
|
|
Placebo Comparator: Non-Numerical Control
|
Children read books containing relevant stimuli.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Flexible Attention to Magnitudes Task
Time Frame: Baseline 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.
|
Baseline and after intervention (up to 4 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Minnesota Executive Function Scale
Time Frame: baseline 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.
|
baseline and immediately after intervention (up to 4 days)
|
|
Change in Number Line Estimation Task
Time Frame: baseline 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.
|
baseline and immediately after (up to 4 days)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- R15HD100936 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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