Understanding Cognitive-Academic Bidirectionality in Math Learning Disabilities

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:

1. One treatment group will receive a validated treatment for math word problem solving plus computerized working memory training.
2. Another treatment group will receive the same validated math treatment plus computerized reading instruction.
3. A control group will receive the conventional school math program, including any additional school-provided intervention.

Participants in both treatment groups will receive 35 minutes of tutoring three times per week for 15 weeks.

Children who are selected to participate in the study will be tested once before this project's intervention begins; twice after intervention starts; twice after intervention ends; and once near the end of second grade to see how long effects last.

Study Overview

• Status: Recruiting
• Conditions: Math Learning Disability
• Intervention / Treatment: Behavioral: Coordinated Treatment; Behavioral: Math Treatment

Detailed Description

The focus of this clinical trial (CT) is an innovative intervention guided by cognitive-academic mutualism theory in which cognitive resources support development of academic competencies while academic learning in turn exercises and strengthens cognitive abilities. The goal of this CT is to test the effects of an innovative intervention designed to improve cognitive ability and academic skill in coordinated fashion and test bidirectionality as a mechanistic process by which effects occur, thereby evaluating the potential for cognitive-academic mutualism to expand the framework for learning disabilities intervention science and advancing understanding about the development of mathematic competence in children. The CT's innovative intervention provides coordinated cognitive training + direct skills math intervention, with supports for cross-domain transfer. The academic focus is math: word-problem solving (WPS) & arithmetic, both critical foundational skills. The cognitive focus is complex working memory span (WM) because WM plays a central role in early math development. Participants are 6-8 years old, a sensitive period when WM malleability and beneficial effects between emerging skills are rich in opportunity & when school instruction on the targeted math competencies intensifies.

Participants are 300 children who begin 1st grade with math delays & low WM. They are identified as meeting inclusion criteria using a 2-stage screening process. Children who enter the study complete pretesting & then are randomly assigned to 3 conditions: (1) CO-Tx, standard-of-care math treatment + computerized WM training, provided contiguously & with coordinated supports for cross-domain transfer (the innovation); (2) M-Tx, the same standard-of- care math treatment + the same amount of computerized reading instructional activities (the contrast standard-of-care condition); & (3) CON, the control group (maturation and the conventional school program, including classroom instruction and school-provided intervention). Children in conditions 1 & 2 receive researcher-delivered intervention at their school for 15 weeks (3 times per week, 35-min per session). WM & math are assessed at pretest, 5 weeks later, another 5 weeks later, posttest, delayed posttest, and follow-up. The study is conducted in 5 cohorts, with 1/5 of the sample entering the study each year.

The Overall Goal is to test CO-Tx's added value over standard-of-care (SOC) math intervention (and over conventional school programming & maturation) while deepening understanding of bidirectional influences between WM & math as a mechanism by which CO-Tx's effects occur and providing insight into cognitive-academic mutualism in children with math delays at start of 1st grade. Aim 1 tests CO-Tx's added value over M-Tx (SOC math intervention + computerized reading activities in each session's 1st component to control for CO-Tx's WM training time) and over CON (the control group) on WM and math (Arith & WPS) at posttest & delayed posttest. One-year follow-up effects are explored. Aim 2 assesses (a) whether bidirectional relations between WM & math are involved in the mediation pathway linking CO-Tx's effects on delayed posttest math & WM and (b) whether bidirectional relations are stronger in CO-Tx than other conditions. Exploratory Aim 3 (subgroup effects) provides insight into the robustness of CO-Tx's effects for boys vs. girls, as a function of economic disadvantage, and for native-Spanish-speaking English learners (i.e., who receive English language services) vs. non-English learners (i.e., native English speakers and non-native-English speakers who do not receive English language services), and ADHD symptom level.

This CT impacts science by deepening understanding about the potential of innovative treatment based on cognitive academic mutualism theory to enhance learning over conventional SOC math intervention; by providing insights into cognitive-academic mutualism as a framework for expanding LD intervention science; and more generally by advancing understanding about cognitive-academic mutualism in developmental science. Results may impact clinical practice by providing proof-of-concept evidence on an innovative approach for advancing LD intervention science. This CT is relevant significant & relevant because math disabilities are associated with poor school, employment, everyday life, & mental health outcomes and given the pressing need to expand the framework for treating LDs.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Caitlin F. Craddock, B.A.; Phone Number: 615-491-1829; Email: c.f.craddock@vanderbilt.edu
• Study Contact Backup: Name: Marcia A. Barnes, Ph.D.; Phone Number: 615-875-2825; Email: marcia.barnes@vanderbilt.edu

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 372032417
      • Recruiting
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criterion:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coordinated Treatment; 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; 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.
Active Comparator: Math Treatment; The math treatment group receives standard-of-care math treatment + computerized reading instructional activities.	Behavioral: Math Treatment; 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.
No Intervention: Control; The control group receives only the conventional school program, including classroom instruction and school-provided intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030

Study Registration Dates

• First Submitted: October 21, 2025
• First Submitted That Met QC Criteria: October 23, 2025
• First Posted (Estimated): October 24, 2025

Study Record Updates

• Last Update Posted (Estimated): October 24, 2025
• Last Update Submitted That Met QC Criteria: October 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: working memory; arithmetic; math word problem solving
• Additional Relevant MeSH Terms: Specific Learning Disorder; Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Communication Disorders; Learning Disabilities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyscalculia
• Other Study ID Numbers: 240343; 1R01HD115592-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

IPD Sharing 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.

• IPD Sharing Access Criteria: The user submits a request describing variables of interest, research aims, & quantitative methods and signs a user agreement form (see Plan Description).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No