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Recruiting NCT05201534

Interventions in Mathematics and Cognitive Skills

No phase Interventional Math Learning Disability Child Development Developmental Disability Learning Disabilities

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Interventions in Mathematics and Cognitive Skills - Experimental, Interventions in Mathematics and Cognitive Skills - Active Comparator.
Who it may be relevant to
Registry conditions: Math Learning Disability, Child Development, Developmental Disability, Learning Disabilities. Basic parameters: 6 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Interventions in Math Learning Disabilities: Cognitive and Neural Correlates

Overview

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.

Interventions

  • 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
  • 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

Primary outcome measures

  • Change from baseline in symbolic number comparison task performance (reaction time) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in symbolic number comparison task performance (accuracy) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in non-symbolic number comparison task performance (reaction time) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in non-symbolic number comparison task performance (accuracy) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of symbolic number comparison task performance (drift rate) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of symbolic number comparison task performance (post-error adjustment) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (drift rate) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (post-error adjustment) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in brain activation during symbolic number comparison task performance [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in brain activation during non-symbolic number comparison task performance [Time frame: Baseline and post-intervention (after 6 weeks)]
Secondary outcome measures (2)
  • Change from baseline in symbolic addition task performance (reaction time) [Time frame: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in symbolic addition task performance (accuracy) [Time frame: Baseline and post-intervention (after 6 weeks)]

Eligibility criteria

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 Scle of Intelligence (WASI-II).
  • 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
  • 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
  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford Cognitive and Systems Neuroscience Laboratory — Palo Alto

Identifiers

NCT: NCT05201534 · 62479 · 2R01HD059205-11A1 · SPO #42749

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗