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Math Learning DisabilityNCT07220746

Understanding Cognitive-Academic Bidirectionality in Math Learning Disabilities

A study testing Coordinated Treatment and Math Treatment in people with Math Learning Disability, run by Vanderbilt University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 8 years
Conditions the study is for
Math Learning Disability
What is being tested?
Coordinated Treatment and Math Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
1 Aug 2025to 30 Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 8 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Caitlin F. Craddock, B.A. contact

615-491-1829

c.f.craddock@vanderbilt.edu

Marcia A. Barnes, Ph.D. contact

615-875-2825

marcia.barnes@vanderbilt.edu

United States1 site, 1 recruiting
  • Vanderbilt University

    Nashville, Tennessee, 372032417

    Recruiting

Other trials in United States

About this study

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?
Read more

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.

Read the 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.

Being tested
Coordinated Treatment, Math Treatment
Keywords
math word problem solving, arithmetic, working memory
Medical subject headings
Dyscalculia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coordinated TreatmentBehavioural

    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.

  • Math TreatmentBehavioural

    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.

Study groups in NCT07220746
Study groupRoleWhat they receive
Coordinated TreatmentExperimentalThe coordinated treatment group receives standard-of-care math treatment + computerized working memory training, provided contiguously \& with coordinated supports for cross-domain transfer.
Receives: Behavioral: Coordinated Treatment
Math TreatmentActive comparatorThe math treatment group receives standard-of-care math treatment + computerized reading instructional activities.
Receives: Behavioral: Math Treatment
ControlNo interventionThe control group receives only the conventional school program, including classroom instruction and school-provided intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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

  2. 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.

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

  3. 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.

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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

  6. 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.

    Measured: 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

  7. 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.

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

  8. GMADE-Problem Solving & Procedures

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2025
  2. Study start1 Aug 2025
  3. Primary completion30 Apr 2030 (estimated)
  4. Study completion30 Apr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220746
Sponsor's protocol ID
240343
Other IDs
1R01HD115592-01A1
Status last verified
Oct 2025
First submitted
21 Oct 2025
Last updated
24 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Coordinated Treatment and Math Treatment in people with Math Learning Disability, run by Vanderbilt University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Caitlin F. Craddock, B.A. (615-491-1829, c.f.craddock@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Arithmetic Combinations (Fuchs et al., 2003) (time frame: 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025; AzTrials last refreshed its copy on 26 Oct 2026.

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