Interventions in Mathematics and Cognitive Skills

NCT ID: NCT05201534

Last Updated: 2025-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-05

Study Completion Date

2026-06-30

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.

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Interventions in Mathematics and Cognitive Skills - Experimental

Intervention Type OTHER

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 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.

Group Type ACTIVE_COMPARATOR

Interventions in Mathematics and Cognitive Skills - Active Comparator

Intervention Type OTHER

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

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Vinod Menon

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford Cognitive and Systems Neuroscience Laboratory

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Vinod Menon, PhD

Role: CONTACT

16507363699

Facility Contacts

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Zehra Unal

Role: primary

737-615-0834

Oliver Lasnick

Role: backup

818-836-7956

Other Identifiers

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2R01HD059205-11A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SPO #42749

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

62479

Identifier Type: -

Identifier Source: org_study_id

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