Interventions in Mathematics and Cognitive Skills

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).

Study Overview

• Status: Recruiting
• Conditions: Cognitive Dysfunction; Cognitive Change; Learning Disabilities; Individuality; Child Development; Developmental Disability; Behavior; Cognition; Learning Curve; Decision Making; Behavior and Behavior Mechanisms; Behavior, Child; Cognitive Impairment, Mild; Cognition Disorder; Neuroscience; Cognitive Orientation; Cognitive Developmental Delay; Neuronal Plasticity; Cognitive Abnormality; Math Learning Disability; Learning Disabled; Mathematics Disorder; Dyscalculia; Dyscalculia, Primary; Dyscalculia, Acquired; Specific Learning Disorder, With Impairment in Mathematics; Cognitive Delay, Mild; Cognitive Deficits, Mild
• Intervention / Treatment: Other: Interventions in Mathematics and Cognitive Skills - Experimental; Other: Interventions in Mathematics and Cognitive Skills - Active Comparator

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vinod Menon, PhD; Phone Number: 16507363699; Email: menon@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford Cognitive and Systems Neuroscience Laboratory
      • Contact: Mai-Phuong Bo; Phone Number: 650-736-3699; Email: maipbo@stanford.edu
      • Principal Investigator: Vinod Menon, Ph.D.
      • Sub-Investigator: Hyesang Chang, Ph.D.
      • Contact: Yunji Park; Phone Number: 6507363699; Email: yunjip@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Elementary school aged children starting from first grade (6-12 years old)
2. IQ: Participants with a Full Scale IQ > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II).
3. Identification of Mathematical Learning Disabilities: Scores below the 25-35th percentile percentile on symbolic number processing test in Numeracy Screener and two or more Wechsler Individual Achievement Test (WIAT-IV) math subtests
4. Identification of typically developing children: Scores at or above the 25-35th percentile percentile on symbolic number processing test in Numeracy Screener and all WIAT-IV math subtests
5. Normal or corrected-to-normal vision and no hearing impairments
6. Inclusion in MRI scan session: Right-handed

Exclusion Criteria:

1. History of neurological or psychiatric disorder (i.e., schizophrenia, psychosis, depression, or attention deficit hyperactivity disorder.)
2. History of trauma involving head injury
3. Consistent psychiatric medications
4. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrative Symbolic Non-Symbolic (iSNS) Training; 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; 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 Comparator: Active Control Intervention (Working Memory Training); 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
Change from baseline in functional connectivity during symbolic addition task performance	Mean functional connectivity between ventrotemporal occipital cortex (VTOC), posterior parietal cortex (PPC), prefrontal cortex (PFC), medial temporal lobe (MTL), and basal ganglia (BG) regions during symbolic addition fMRI task will be assessed. Data will consist of generalized psychophysiological interaction (gPPI) beta values from individual subject contrast maps for Hard vs. Easy contrast for the regions of interest (VTOC, PPC, PFC, MTL, BG).	Baseline and post-intervention (after 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in symbolic addition task performance (reaction time)	Performance will be measured by children's reaction time (milliseconds) on symbolic addition task	Baseline and post-intervention (after 6 weeks)
Change from baseline in symbolic addition task performance (accuracy)	Performance will be measured by children's accuracy (% trials correct) on symbolic addition task	Baseline and post-intervention (after 6 weeks)
Change from baseline in functional connectivity during symbolic number comparison task performance	Mean functional connectivity between ventrotemporal occipital cortex (VTOC), posterior parietal cortex (PPC), prefrontal cortex (PFC), medial temporal lobe (MTL), and basal ganglia (BG) regions during symbolic number comparison fMRI task will be assessed. Data will consist of generalized psychophysiological interaction (gPPI) beta values from individual subject contrast maps for Near vs. Far contrast for the regions of interest (VTOC, PPC, PFC, MTL, BG).	Baseline and post-intervention (after 6 weeks)
Change from baseline in functional connectivity during non-symbolic number comparison task performance	Mean functional connectivity between ventrotemporal occipital cortex (VTOC), posterior parietal cortex (PPC), prefrontal cortex (PFC), medial temporal lobe (MTL), and basal ganglia (BG) regions during non-symbolic number comparison fMRI task will be assessed. Data will consist of generalized psychophysiological interaction (gPPI) beta values from individual subject contrast maps for Near vs. Far contrast for the regions of interest (VTOC, PPC, PFC, MTL, BG).	Baseline and post-intervention (after 6 weeks)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 7, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): August 7, 2023
• Last Update Submitted That Met QC Criteria: August 3, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Early Intervention, Educational; Neural Networks, Computer; Mathematics; Numerical skills in children; Low math abilities; Mathematical Learning Disabilities; Mathematical Concepts; Transfer, Psychology; Generalization, Psychology; Neural Pathways
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Neurodevelopmental Disorders; Communication Disorders; Cognitive Dysfunction; Cognition Disorders; Developmental Disabilities; Learning Disabilities; Specific Learning Disorder; Dyscalculia
• Other Study ID Numbers: 62479; 2R01HD059205-11A1 (U.S. NIH Grant/Contract); SPO #42749 (Other Grant/Funding Number: Stanford Sponsored Projects Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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