AzTrials
AzTrials

Math Learning DisabilityNCT05201534

Interventions in Mathematics and Cognitive Skills

A study testing Interventions in Mathematics and Cognitive Skills - Experimental and Interventions in Mathematics and Cognitive Skills - Active Comparator in people with Math Learning Disability and Child Development, run by Stanford 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 purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD). Read more about this study

Who is it for?
Ages 6 to 12 yearsHealthy volunteers can take part
What is being tested?
Interventions in Mathematics and Cognitive Skills - Experimental and Interventions in Mathematics and Cognitive Skills - Active Comparator
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
5 May 2023to 31 Aug 2027
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 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Elementary school aged children starting from first grade (6-12 years old)
  • IQ: Participants with a Full Scale IQ > 70 on the Wechsler Abbreviated Scle of Intelligence (WASI-II).
  • Identification of Mathematical Learning Disabilities: Scores below the 35th percentile percentile on symbolic number processing test in Numeracy Screener and two or more Wechsler Individual Achievement Test (WIAT-IV) math subtests
  • Identification of typically developing children: Scores at or above the 35th percentile percentile on symbolic number processing test in Numeracy Screener and all WIAT-IV math subtests
  • Normal or corrected-to-normal vision and no hearing impairments
  • Inclusion in MRI scan session: Right-handed

Who cannot join

  • History of neurological or psychiatric disorder (i.e., schizophrenia, psychosis, depression, or attention deficit hyperactivity disorder.)
  • History of trauma involving head injury
  • Consistent psychiatric medications
  • Exclusion from MRI scan session: No major contraindication for magnetic resonance imaging (MRI) - braces, metal implants, pacemakers, vascular stents, metallic ear tubes, consistent exposure to metal, claustrophobia)

Trial locations and contacts

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

Vinod Menon, PhD contact

16507363699

menon@stanford.edu

United States1 site, 1 recruiting
  • Stanford Cognitive and Systems Neuroscience Laboratory

    Palo Alto, California, 94304

    Zehra Unal, 737-615-0834, zehraeu@stanford.edu

    Oliver Lasnick, 818-836-7956, ohml@stanford.edu

    Recruiting

Other trials in United States

About this study

Official title: Interventions in Math Learning Disabilities: Cognitive and Neural Correlates

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

Read the detailed description

The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing, and remediating weaknesses in, numerical skills in children, including those with mathematical learning disabilities (MLD).

To achieve this goal, investigators will use a theoretically-motivated integrated symbolic/non-symbolic (iSNS) intervention with a randomized controlled design to enhance cross-format mapping between symbolic and nonsymbolic representations of quantities. The investigators will develop innovative computational models to investigate individual differences in latent cognitive processes and brain plasticity that contribute to learning, long-term retention, and transfer in children.

The investigators will assess performance in several areas and investigate cognitive and neural mechanisms that support numerical skill acquisition in children with differing levels of math learning abilities.

Being tested
Interventions in Mathematics and Cognitive Skills - Experimental, Interventions in Mathematics and Cognitive Skills - Active Comparator
Keywords
Numerical skills in children, Low math abilities, Mathematical Learning Disabilities, Mathematical Concepts, Mathematics, Transfer, Psychology, Generalization, Psychology, Early Intervention, Educational, Neural Pathways, Neural Networks, Computer
Medical subject headings
Dyscalculia, Developmental Disabilities, Learning Disabilities, Specific Learning Disorder, Child Behavior, Behavior, Cognition Disorders, Cognitive Dysfunction

What participants receive

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

  • Interventions in Mathematics and Cognitive Skills - ExperimentalOther

    After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-training MRI brain scan (if eligible) and behavioral assessments and will then be assigned to the intervention for 6 weeks.

    During this training, participants will spend three days each week completing a set of problems at their home on a tablet that we provide them. Participants will receive one-to-one training with a member of our research team once a week.

    Following the completion of the 6-week training program, participants will be asked to complete a second MRI brain imaging session (for those who completed pre-training MRI) and post-measure appointments in order to assess immediate effects of the training program. Participants will also be invited to return for follow-up testing after six months in order to assess the long- lasting effects of the training program.

  • Interventions in Mathematics and Cognitive Skills - Active ComparatorOther

    After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-training MRI brain scan (if eligible) and behavioral assessments and will then be assigned to the intervention for 6 weeks.

    During this training, participants will spend three days each week completing a set of problems at their home on a tablet that we provide them. Participants will receive one-to-one training with a member of our research team once a week.

    Following the completion of the 6-week training program, participants will be asked to complete a second MRI brain imaging session (for those who completed pre-training MRI) and post-measure appointments in order to assess immediate effects of the training program. Participants will also be invited to return for follow-up testing after six months in order to assess the long- lasting effects of the training program.

Study groups in NCT05201534
Study groupRoleWhat they receive
Integrative Symbolic Non-Symbolic (iSNS) TrainingExperimentalIntegrative symbolic non-symbolic (iSNS) training: Over a period of 6 weeks, participants will complete activities that progressively strengthen the mapping of symbolic numerical representations to non-symbolic numerical quantities and enhance fluency in symbolic numerical skills.
Receives: Other: Interventions in Mathematics and Cognitive Skills - Experimental
Active Comparator: Active Control Intervention (Working Memory Training)Active comparatorActive control intervention: Over a period of 6 weeks, participants will complete activities that enhance short-term storage and maintenance of visuospatial or verbal information.
Receives: Other: Interventions in Mathematics and Cognitive Skills - Active Comparator

What is being measured

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

  1. Change from baseline in symbolic number comparison task performance (reaction time)

    Performance will be measured by children's reaction time (milliseconds) on symbolic number comparison task

    Measured: Baseline and post-intervention (after 6 weeks)

  2. Change from baseline in symbolic number comparison task performance (accuracy)

    Performance will be measured by children's accuracy (% trials correct) on symbolic number comparison task

    Measured: Baseline and post-intervention (after 6 weeks)

  3. Change from baseline in non-symbolic number comparison task performance (reaction time)

    Performance will be measured by children's reaction time (milliseconds) on non-symbolic number comparison task

    Measured: Baseline and post-intervention (after 6 weeks)

  4. Change from baseline in non-symbolic number comparison task performance (accuracy)

    Performance will be measured by children's accuracy (% trials correct) on non-symbolic number comparison task

    Measured: Baseline and post-intervention (after 6 weeks)

  5. Change from baseline in latent cognitive measures of symbolic number comparison task performance (drift rate)

    Latent cognitive processing will be measured by drift rate from children's symbolic number comparison task performance

    Measured: Baseline and post-intervention (after 6 weeks)

  6. Change from baseline in latent cognitive measures of symbolic number comparison task performance (post-error adjustment)

    Latent cognitive processing will be measured by post-error adjustment from children's symbolic number comparison task performance

    Measured: Baseline and post-intervention (after 6 weeks)

  7. Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (drift rate)

    Latent cognitive processing will be measured by drift rate from children's non-symbolic number comparison task performance

    Measured: Baseline and post-intervention (after 6 weeks)

  8. Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (post-error adjustment)

    Latent cognitive processing will be measured by post-error adjustment from children's non-symbolic number comparison task performance

    Measured: Baseline and post-intervention (after 6 weeks)

  9. Change from baseline in brain activation during symbolic number comparison task performance

    Neural activity will be measured during functional magnetic resonance imaging (fMRI) symbolic number comparison task. Data will consist of beta values from individual subject contrast maps for Near vs Far contrast from the whole-brain GLM fMRI analysis.

    Measured: Baseline and post-intervention (after 6 weeks)

  10. Change from baseline in brain activation during non-symbolic number comparison task performance

    Neural activity will be measured during functional magnetic resonance imaging (fMRI) non-symbolic number comparison task. Data will consist of beta values from individual subject contrast maps for Near vs Far contrast from the whole-brain general linear model (GLM) fMRI analysis.

    Measured: Baseline and post-intervention (after 6 weeks)

Secondary outcomes (2)
  1. Change from baseline in symbolic addition task performance (reaction time)

    Performance will be measured by children's reaction time (milliseconds) on symbolic addition task

    Measured: Baseline and post-intervention (after 6 weeks)

  2. Change from baseline in symbolic addition task performance (accuracy)

    Performance will be measured by children's accuracy (% trials correct) on symbolic addition task

    Measured: Baseline and post-intervention (after 6 weeks)

Timeline

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

  1. First posted21 Jan 2022
  2. Study start5 May 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2027 (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
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05201534
Sponsor's protocol ID
62479
Other IDs
2R01HD059205-11A1, SPO #42749
Status last verified
Jun 2026
First submitted
7 Jan 2022
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Interventions in Mathematics and Cognitive Skills - Experimental and Interventions in Mathematics and Cognitive Skills - Active Comparator in people with Math Learning Disability and Child Development, run by Stanford 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 4 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 11 Aug 2026. 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 Vinod Menon, PhD (16507363699, menon@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in symbolic number comparison task performance (reaction time) (time frame: Baseline and post-intervention (after 6 weeks)). The study lists 10 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 11 Aug 2026.

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