NCT07220746

Brief Summary

The goal of this clinical trial is to test the effects of an innovative intervention designed to improve math skills in first graders at risk for math disabilities. The main questions the trial aims to answer are:

  • Does combining a math word problem solving intervention with a working memory intervention improve math to a greater extent than the same math intervention without cognitive training?
  • Do the findings provide evidence for bidirectional effects on development? In other words, does working memory support math learning and does math learning support working memory development? Screening for eligibility will take place in two testing sessions. Students who meet the eligibility criteria will be randomly assigned to one of three groups:
  • One treatment group will receive a validated treatment for math word problem solving plus computerized working memory training.
  • Another treatment group will receive the same validated math treatment plus computerized reading instruction.
  • A control group will receive the conventional school math program, including any additional school-provided intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
49mo left

Started Aug 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress16%
Aug 2025Apr 2030

Study Start

First participant enrolled

August 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 24, 2025

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2030

Last Updated

October 24, 2025

Status Verified

October 1, 2025

Enrollment Period

4.7 years

First QC Date

October 21, 2025

Last Update Submit

October 23, 2025

Conditions

Keywords

math word problem solvingarithmeticworking memory

Outcome Measures

Primary Outcomes (8)

  • Arithmetic Combinations (Fuchs et al., 2003)

    Children have 1 minute to write answers to 25 addition items (sums 5-12); 1 minute same for subtraction items (minuends 5-12); same 1 minute for 25 addition items (sums 5-18); same and 1 minute for 25 subtraction items (minuends 5-18).

    Pretest before treatment begins, 5 weeks after treatment starts, 10 weeks after treatment starts, 15 weeks after treatment starts, 20 weeks after treatment starts, 1 year + 20 weeks after treatment starts

  • Pennies Story Problems (Jordan & Hanich, 2000) (Jordan & Hanich, 2000)

    The test comprises 14 combine, compare and change word problems, each involving penny scenarios and requiring sums and minuends to 12. Items are scored for correct math.

    Pretest before treatment begins, 5 weeks after treatment starts, 10 weeks after treatment starts, 15 weeks after treatment starts

  • Word Problem Test (Fuchs et al., 2021)

    The test comprises 12 combine, compare and change word problems, some with irrelevant information and/or transfer features (e.g., relevant numbers in graphs and tables, implicit change verbs (e.g. Lost). Items are scored for correct arithmetic and correct label to reflect understanding of both the word problem narrative (i.e,, that the child includes the label "trucks" in their answer if the story had to do with transforming quantitative information having to do with the number of trucks), and the mathematics required to accurately solve the problem.

    Pretest before treatment begins, 5 weeks after treatment starts, 10 weeks after treatment starts, 15 weeks after treatment starts, 20 weeks after treatment starts, 1 year + 20 weeks after treatment starts

  • Working Memory Assessment-Odd-One Out (Alloway, 2012)

    Children see 3 shapes, each in a box shown in a row, and identify the odd-one-out; after making odd-one-out determinations for a series of rows, they recall the location of each odd-one-out shape in order by tapping boxes.

    Pretest before treatment begins, 5 weeks after treatment starts, 10 weeks after treatment starts, 15 weeks after treatment starts, 20 weeks after treatment starts, 1 year + 20 weeks after treatment starts

  • Working Memory Test Battery - Children - Listening Recall (Pickering & Gathercole, 2001)

    Children decide if a sentence is true; after making true/false determinations for a series of sentences, they recall the last word of each sentence in order.

    Pretest before treatment begins, 5 weeks after treatment starts, 10 weeks after treatment starts, 15 weeks after treatment starts, 20 weeks after treatment starts, 1 year + 20 weeks after treatment starts

  • Working Memory Test Battery- Children - Counting Recall (Pickering & Gathercole, 2001)

    Children count a set of 4, 5, 6, or 7 dots on a card; after counting a series of cards, they recall the counts in order.

    Pretest before treatment begins, 5 weeks after treatment starts, 10 weeks after treatment starts, 15 weeks after treatment starts, 20 weeks after treatment starts, 1 year + 20 weeks after treatment starts

  • Wide Range Achievement Test-5-Math

    Test includes an oral section on early numerical competencies (e.g., counting) \& a 10-min written section on calculations.

    Pretest before treatment begins, 15 weeks after treatment starts, 1 year + 20 weeks after treatment starts

  • GMADE-Problem Solving & Procedures

    Tests assesses word problem solving and math applications with 28 items.

    15 weeks after treatment starts, 1 year + 20 weeks after treatment starts

Study Arms (3)

Coordinated Treatment

EXPERIMENTAL

The coordinated treatment group receives standard-of-care math treatment + computerized working memory training, provided contiguously \& with coordinated supports for cross-domain transfer.

Behavioral: Coordinated Treatment

Math Treatment

ACTIVE COMPARATOR

The math treatment group receives standard-of-care math treatment + computerized reading instructional activities.

Behavioral: Math Treatment

Control

NO INTERVENTION

The control group receives only the conventional school program, including classroom instruction and school-provided intervention.

Interventions

Coordinated Treatment provides 15 weeks (3 35-minute sessions per week) of intervention. Each session comprises 2 components delivered contiguously by the same tutor: 15 min of working memory training, immediately followed by 20 min of math (arithmetic \& word-problem solving)intervention. Explicit transfer instruction is woven into both components.

Coordinated Treatment
Math TreatmentBEHAVIORAL

Math Treatment provides 15 weeks (three 35-minute sessions per week) of intervention. Each session comprises 2 components delivered contiguously by the same tutor: 15 min of computerized reading instruction, immediately followed by 20 min of math (arithmetic \& word-problem solving) intervention.

Math Treatment

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Attends a participating school in the Metropolitan-Nashville Public Schools
  • Is a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Has the available school schedule to participate
  • Scores below the 30th percentile on the study's screening math test
  • Scores below the 50th percentile on the study's working memory test
  • Scores at or above the 7th percentile on at least one of the study's two measures of cognitive performance
  • Does not attend a participating school in the Metropolitan-Nashville Public Schools
  • Is not a member of a first-grade classroom whose teacher has agreed to let his/her students participate
  • Does not have the available school schedule to participate
  • Scores at or above 30th percentile on the study's screening math test
  • Scores at or above the 50th percentile on the study's screening working test
  • Scores below the 7th percentile on both of the study's two measures of cognitive performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 372032417, United States

RECRUITING

MeSH Terms

Conditions

Dyscalculia

Condition Hierarchy (Ancestors)

Specific Learning DisorderLearning DisabilitiesCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Caitlin F. Craddock, B.A.

CONTACT

Marcia A. Barnes, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 21, 2025

First Posted

October 24, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

April 30, 2030

Study Completion (Estimated)

April 30, 2030

Last Updated

October 24, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

Research staff will make de-identified data sets electronically available to external users under a data-sharing agreement providing the user's commitment to use data for the research purposes described in the user's request; assurance that no research participant will be identified for any purpose; a commitment to securing the data; a commitment to not transferring data to other users \& destroying the data after analyses are complete; \& guarantees publications are credited to grant/agency and entered in PubMed. Once the user signs and returns the Agreement Form, a database with the variables of interest and codebook are provided, and staff provide relevant, de-identified data and segments of the code book with variable names/values, notes clarifying scoring/data-reduction methods not otherwise available, and a technical report describing the sample, study, and procedures.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The de-identified (stripped) primary outcome data set will become available no later than acceptance for publication of the main findings from the final data set and remain accessible for 3 years following the closeout of this grant. This time frame for data accessibility will be reviewed at the proposed project's completion and revised as needed. If all Investigators leave or become unavailable, the last remaining Investigator will assume responsibility for identifying a Vanderbilt faculty member to undertake these responsibilities.
Access Criteria
The user submits a request describing variables of interest, research aims, \& quantitative methods and signs a user agreement form (see Plan Description).
More information

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