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NCT Number: NCT05201534

Interventions in Mathematics and Cognitive Skills

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).

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Key information

Conditions

Math Learning Disability Behavior Behavior and Behavior Mechanisms Behavior, Child Child Behavior Child Development Cognition Cognition Disorder Cognition Disorders Cognitive Abnormality Cognitive Change Cognitive Deficits, Mild Cognitive Delay, Mild Cognitive Developmental Delay Cognitive Dysfunction Cognitive Impairment, Mild Cognitive Orientation Communication Disorders Decision Making Developmental Disabilities Developmental Disability Dyscalculia Dyscalculia, Acquired Dyscalculia, Primary Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Individuality Learning Curve Learning Disabilities Learning Disabled Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Mathematics Disorder Mental Disorders Neoplasms Neoplasms by Histologic Type Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodevelopmental Disorders Neurologic Manifestations Neuronal Plasticity Neuroscience Orientation, Spatial Pathological Conditions, Signs and Symptoms Signs and Symptoms Spatial Behavior Specific Learning Disorder Specific Learning Disorder, With Impairment in Mathematics

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford Cognitive and Systems Neuroscience Laboratory

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Oliver Lasnick

CONTACT

[email protected]

818-836-7956

Vinod Menon, Ph.D.

PRINCIPAL_INVESTIGATOR

Yunji Park, Ph.D.

SUB_INVESTIGATOR

Zehra Unal

CONTACT

[email protected]

737-615-0834

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Interventions in Mathematics and Cognitive Skills - Experimental

Other

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 Comparator

Other

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.

Primary outcomes

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

    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.

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

    Time frame: Baseline and post-intervention (after 6 weeks)

    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.

Secondary outcomes

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

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

    Time frame: Baseline and post-intervention (after 6 weeks)

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

Study contacts

Contact information is provided by the study sponsor or research team.

Vinod Menon, PhD

CONTACT

[email protected]

16507363699

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Interventions in Math Learning Disabilities: Cognitive and Neural Correlates

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2022
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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