NCT05682729

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 30, 2025

Completed
Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

10 months

First QC Date

December 19, 2022

Results QC Date

July 1, 2024

Last Update Submit

October 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and after intervention (up to 4 days)

Secondary Outcomes (2)

  • Change in Minnesota Executive Function Scale

    baseline and immediately after intervention (up to 4 days)

  • Change in Number Line Estimation Task

    baseline and immediately after (up to 4 days)

Study Arms (4)

Size to Number

EXPERIMENTAL
Behavioral: Book Reading Intervention

Mixed

EXPERIMENTAL
Behavioral: Book Reading Intervention

Traditional Counting

ACTIVE COMPARATOR
Behavioral: Book Reading Intervention

Non-Numerical Control

PLACEBO COMPARATOR
Behavioral: Book Reading Intervention

Interventions

Children read books containing relevant stimuli.

MixedNon-Numerical ControlSize to NumberTraditional Counting

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Child ages 3 - 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Early Childhood Education Facilities

Dayton, Ohio, 45469, United States

Location

Results Point of Contact

Title
Mary Wagner
Organization
University of Dayton

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2022

First Posted

January 12, 2023

Study Start

September 1, 2022

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

October 30, 2025

Results First Posted

October 30, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Anonymized pre- and post-test scores will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Data available when published through the Open Science Framework (OSF).

Locations