Interventions in Mathematics and Cognitive Skills

Study Purpose

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	6 Years - 12 Years
Gender	All

More Inclusion & Exclusion 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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05201534
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Stanford University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	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

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Active Comparator: 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.

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 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.

Other: - Interventions in Mathematics and Cognitive Skills - Active Comparator

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Palo Alto 5380748, California 5332921

Status

Recruiting

Address

Stanford Cognitive and Systems Neuroscience Laboratory

Palo Alto 5380748, California 5332921, 94304

Site Contact

Zehra Unal

[email protected]

737-615-0834

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