Interventions in Mathematics and Cognitive Skills

Sponsor
Stanford University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05201534
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
180
2
45.9

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Interventions in Math Learning Disabilities: Cognitive and Neural Correlates
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jun 30, 2026
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Integrative Symbolic Non-Symbolic (iSNS) Training

Integrative symbolic non-symbolic (iSNS) training: Over a period of 8 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
After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-training MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 8 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 8-week training program, participants will be asked to complete a second MRI brain imaging session, followed by 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 8 weeks, participants will complete activities that enhance short-term storage and maintenance of visuospatial or verbal information, including an adapted Cogmed Working Memory Training program.

Other: Interventions in Mathematics and Cognitive Skills
After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-training MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 8 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 8-week training program, participants will be asked to complete a second MRI brain imaging session, followed by 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.

Outcome Measures

Primary Outcome Measures

  1. Change from baseline in symbolic number comparison task performance (reaction time) [Baseline and post-intervention (after 8 weeks)]

    Performance will be measured by children's reaction time (milliseconds) on symbolic number comparison task

  2. Change from baseline in symbolic number comparison task performance (accuracy) [Baseline and post-intervention (after 8 weeks)]

    Performance will be measured by children's accuracy (% trials correct) on symbolic number comparison task

  3. Change from baseline in non-symbolic number comparison task performance (reaction time) [Baseline and post-intervention (after 8 weeks)]

    Performance will be measured by children's reaction time (milliseconds) on non-symbolic number comparison task

  4. Change from baseline in non-symbolic number comparison task performance (accuracy) [Baseline and post-intervention (after 8 weeks)]

    Performance will be measured by children's accuracy (% trials correct) on non-symbolic number comparison task

  5. Change from baseline in latent cognitive measures of symbolic number comparison task performance (drift rate) [Baseline and post-intervention (after 8 weeks)]

    Latent cognitive processing will be measured by drift rate from children's symbolic number comparison task performance

  6. Change from baseline in latent cognitive measures of symbolic number comparison task performance (post-error adjustment) [Baseline and post-intervention (after 8 weeks)]

    Latent cognitive processing will be measured by post-error adjustment from children's symbolic number comparison task performance

  7. Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (drift rate) [Baseline and post-intervention (after 8 weeks)]

    Latent cognitive processing will be measured by drift rate from children's non-symbolic number comparison task performance

  8. Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (post-error adjustment) [Baseline and post-intervention (after 8 weeks)]

    Latent cognitive processing will be measured by post-error adjustment from children's non-symbolic number comparison task performance

  9. Change from baseline in brain activation during symbolic number comparison task performance [Baseline and post-intervention (after 8 weeks)]

    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.

  10. Change from baseline in brain activation during non-symbolic number comparison task performance [Baseline and post-intervention (after 8 weeks)]

    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.

  11. Change from baseline in functional connectivity during symbolic addition task performance [Baseline and post-intervention (after 8 weeks)]

    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

  1. Change from baseline in symbolic addition task performance (reaction time) [Baseline and post-intervention (after 8 weeks)]

    Performance will be measured by children's reaction time (milliseconds) on symbolic addition task

  2. Change from baseline in symbolic addition task performance (accuracy) [Baseline and post-intervention (after 8 weeks)]

    Performance will be measured by children's accuracy (% trials correct) on symbolic addition task

  3. Change from baseline in functional connectivity during symbolic number comparison task performance [Baseline and post-intervention (after 8 weeks)]

    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).

  4. Change from baseline in functional connectivity during non-symbolic number comparison task performance [Baseline and post-intervention (after 8 weeks)]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Children aged 6-8 years old

  2. Intelligence Quotient (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 25th percentile on symbolic number processing test in Numeracy Screener and two or more Wechsler Individual Achievement Test (WIAT-III) math subtests

  4. 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

  5. Right-handed

  6. Normal or corrected-to-normal vision and no hearing impairments

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. No major contraindication for magnetic resonance imaging (MRI) - braces, metal implants, pacemakers, vascular stents, metallic ear tubes, consistent exposure to metal, claustrophobia)

  5. Low birth weight (under 4.4lbs) or significant difficulty during pregnancy, labor, delivery, or immediate neonatal period

  6. Pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Vinod Menon, Professor, Stanford University
ClinicalTrials.gov Identifier:
NCT05201534
Other Study ID Numbers:
  • 62479
  • 2R01HD059205-11A1
  • SPO #42749
First Posted:
Jan 21, 2022
Last Update Posted:
Jan 21, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vinod Menon, Professor, Stanford University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 21, 2022