Back to resultsInterventions in Mathematics and Cognitive Skills
Primary Purpose
Math Learning Disability, Child Development, Developmental Disability
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interventions in Mathematics and Cognitive Skills - Experimental
Interventions in Mathematics and Cognitive Skills - Active Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Math Learning Disability focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Children aged 6-8 years old
- Intelligence Quotient (IQ): Participants with a Full Scale IQ > 70 on the Wechsler Abbreviated Scale of Intelligence (WASI-II).
- Identification of Mathematical Learning Disabilities: Scores below the 25th percentile on symbolic number processing test in Numeracy Screener and two or more Wechsler Individual Achievement Test (WIAT-III) math subtests
- Identification of typically developing children: Scores at or above the 50th percentile on symbolic number processing test in Numeracy Screener and all WIAT-III math subtests
- Right-handed
- Normal or corrected-to-normal vision and no hearing impairments
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
- No major contraindication for magnetic resonance imaging (MRI) - braces, metal implants, pacemakers, vascular stents, metallic ear tubes, consistent exposure to metal, claustrophobia)
- Low birth weight (under 4.4lbs) or significant difficulty during pregnancy, labor, delivery, or immediate neonatal period
- Pregnancy
Sites / Locations
- Stanford Cognitive and Systems Neuroscience LaboratoryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Integrative Symbolic Non-Symbolic (iSNS) Training
Active Comparator: Active Control Intervention (Working Memory Training)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
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
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
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.
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.
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).
Secondary Outcome Measures
Change from baseline in symbolic addition task performance (reaction time)
Performance will be measured by children's reaction time (milliseconds) on symbolic addition task
Change from baseline in symbolic addition task performance (accuracy)
Performance will be measured by children's accuracy (% trials correct) on symbolic addition task
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).
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).
Full Information
NCT ID
NCT05201534
First Posted
January 7, 2022
Last Updated
August 3, 2023
Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05201534
Brief Title
Interventions in Mathematics and Cognitive Skills
Official Title
Interventions in Math Learning Disabilities: Cognitive and Neural Correlates
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 5, 2023 (Actual)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrative Symbolic Non-Symbolic (iSNS) Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Active Comparator: Active Control Intervention (Working Memory Training)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Interventions in Mathematics and Cognitive Skills - Experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Interventions in Mathematics and Cognitive Skills - Active Comparator
Intervention Description
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 Outcome Measure Information:
Title
Change from baseline in symbolic number comparison task performance (reaction time)
Description
Performance will be measured by children's reaction time (milliseconds) on symbolic number comparison task
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in symbolic number comparison task performance (accuracy)
Description
Performance will be measured by children's accuracy (% trials correct) on symbolic number comparison task
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in non-symbolic number comparison task performance (reaction time)
Description
Performance will be measured by children's reaction time (milliseconds) on non-symbolic number comparison task
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in non-symbolic number comparison task performance (accuracy)
Description
Performance will be measured by children's accuracy (% trials correct) on non-symbolic number comparison task
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in latent cognitive measures of symbolic number comparison task performance (drift rate)
Description
Latent cognitive processing will be measured by drift rate from children's symbolic number comparison task performance
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in latent cognitive measures of symbolic number comparison task performance (post-error adjustment)
Description
Latent cognitive processing will be measured by post-error adjustment from children's symbolic number comparison task performance
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (drift rate)
Description
Latent cognitive processing will be measured by drift rate from children's non-symbolic number comparison task performance
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (post-error adjustment)
Description
Latent cognitive processing will be measured by post-error adjustment from children's non-symbolic number comparison task performance
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in brain activation during symbolic number comparison task performance
Description
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.
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in brain activation during non-symbolic number comparison task performance
Description
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.
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in functional connectivity during symbolic addition task performance
Description
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).
Time Frame
Baseline and post-intervention (after 6 weeks)
Secondary Outcome Measure Information:
Title
Change from baseline in symbolic addition task performance (reaction time)
Description
Performance will be measured by children's reaction time (milliseconds) on symbolic addition task
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in symbolic addition task performance (accuracy)
Description
Performance will be measured by children's accuracy (% trials correct) on symbolic addition task
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in functional connectivity during symbolic number comparison task performance
Description
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).
Time Frame
Baseline and post-intervention (after 6 weeks)
Title
Change from baseline in functional connectivity during non-symbolic number comparison task performance
Description
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).
Time Frame
Baseline and post-intervention (after 6 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 Scale of Intelligence (WASI-II).
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
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
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vinod Menon, PhD
Phone
16507363699
Email
menon@stanford.edu
Facility Information:
Facility Name
Stanford Cognitive and Systems Neuroscience Laboratory
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mai-Phuong Bo
Phone
650-736-3699
Email
maipbo@stanford.edu
First Name & Middle Initial & Last Name & Degree
Yunji Park
Phone
6507363699
Email
yunjip@stanford.edu
First Name & Middle Initial & Last Name & Degree
Vinod Menon, Ph.D.
First Name & Middle Initial & Last Name & Degree
Hyesang Chang, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interventions in Mathematics and Cognitive Skills
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