Interventions in Mathematics and Cognitive Skills

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Other: Interventions in Mathematics and Cognitive Skills - Experimental
* Other: Interventions in Mathematics and Cognitive Skills - Active Comparator


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Symbolic Non-Symbolic (iSNS) Training<br>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<br>* 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.<br>|
| Active Comparator: Active Comparator: Active Control Intervention (Working Memory Training)<br>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<br>* 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.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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