Interventions in Mathematics and Cognitive Skills

Child Development Clinical Trial

Official title:

Interventions in Math Learning Disabilities: Cognitive and Neural Correlates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05201534
• Other study ID #: 62479
• Secondary ID: 2R01HD059205-11A
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: Vinod Menon, PhD
• Phone: 16507363699
• Email: menon[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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)

Related Conditions & MeSH terms

• Behavior
• Behavior and Behavior Mechanisms
• Behavior, Child
• Child Development
• Cognition
• Cognition Disorder
• Cognition Disorders
• Cognitive Abnormality
• Cognitive Change
• Cognitive Developmental Delay
• Cognitive Dysfunction
• Cognitive Impairment, Mild
• Cognitive Orientation
• Decision Making
• Developmental Disabilities
• Developmental Disability
• Dyscalculia
• Individuality
• Learning Curve
• Learning Disabilities
• Math Learning Disability
• Neuronal Plasticity
• Neuroscience
• Specific Learning Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Stanford Cognitive and Systems Neuroscience Laboratory	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)