Interventions in Mathematics and Cognitive Skills

NCT05201534 | Recruiting

• 3 other identifiers: 624792R01HD059205-11A1SPO #42749
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Math Learning Disability; Child Development; Developmental Disability; Learning Disabilities; Learning Disabled; Learning Curve; Mathematics Disorder; Dyscalculia; Dyscalculia, Primary; Dyscalculia, Acquired; Specific Learning Disorder, With Impairment in Mathematics; Individuality; Behavior, Child; Behavior and Behavior Mechanisms; Behavior; Decision Making; Neuronal Plasticity; Cognition; Cognition Disorder; Cognitive Dysfunction; Cognitive Change; Cognitive Impairment, Mild; Cognitive Developmental Delay; Cognitive Orientation; Cognitive Delay, Mild; Cognitive Deficits, Mild; Cognitive Abnormality; Neuroscience

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

Outcome Measures

Primary Outcomes (10)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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

  Baseline and post-intervention (after 6 weeks)

• 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.

  Baseline and post-intervention (after 6 weeks)

• 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.

  Baseline and post-intervention (after 6 weeks)

Secondary Outcomes (2)

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

  Baseline and post-intervention (after 6 weeks)

• Change from baseline in symbolic addition task performance (accuracy)

  Baseline and post-intervention (after 6 weeks)

Study Arms (2)

Integrative Symbolic Non-Symbolic (iSNS) Training

EXPERIMENTAL

Integrative 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.

Other: Interventions in Mathematics and Cognitive Skills - Experimental

Active Comparator: Active Control Intervention (Working Memory Training)

ACTIVE COMPARATOR

Active control intervention: Over a period of 6 weeks, participants will complete activities that enhance short-term storage and maintenance of visuospatial or verbal information.

Other: Interventions in Mathematics and Cognitive Skills - Active Comparator

Interventions

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.

Integrative Symbolic Non-Symbolic (iSNS) Training

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.

Active Comparator: Active Control Intervention (Working Memory Training)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Stanford Cognitive and Systems Neuroscience Laboratory

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Dyscalculia; Developmental Disabilities; Learning Disabilities; Specific Learning Disorder; Child Behavior; Behavior; Cognition Disorders; Cognitive Dysfunction; Orientation, Spatial; Lymphoma, Follicular

Interventions

Methods

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Neurocognitive Disorders; Spatial Behavior; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Vinod Menon, PhD

CONTACT

16507363699; menon@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 21, 2022
• Study Start: May 5, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)