Clinical trial NCT05201534: Interventions in Mathematics and Cognitive Skills
Official title: Interventions in Math Learning Disabilities: Cognitive and Neural Correlates
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2022-01-21
Enrollment: 180
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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 Scle of Intelligence (WASI-II).
3. 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
4. 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
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)

Primary outcomes:
measure: Change from baseline in symbolic number comparison task performance (reaction time)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in symbolic number comparison task performance (accuracy)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in non-symbolic number comparison task performance (reaction time)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in non-symbolic number comparison task performance (accuracy)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in latent cognitive measures of symbolic number comparison task performance (drift rate)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in latent cognitive measures of symbolic number comparison task performance (post-error adjustment)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (drift rate)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (post-error adjustment)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in brain activation during symbolic number comparison task performance
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in brain activation during non-symbolic number comparison task performance
timeFrame: Baseline and post-intervention (after 6 weeks)
Secondary outcomes:
measure: Change from baseline in symbolic addition task performance (reaction time)
timeFrame: Baseline and post-intervention (after 6 weeks)
measure: Change from baseline in symbolic addition task performance (accuracy)
timeFrame: Baseline and post-intervention (after 6 weeks)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Cognitive and Systems Neuroscience Laboratory
state: California
Study officials:
References: