About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Interventions in Mathematics and Cognitive Skills - Experimental
Other interventionAfter 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 in Mathematics and Cognitive Skills - Active Comparator
Other interventionAfter 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.
Treatment groups
Trial outcomes
Primary outcomes
Change from baseline in symbolic number comparison task performance (reaction time)
Performance will be measured by children's reaction time (milliseconds) on symbolic number comparison task
Change from baseline in symbolic number comparison task performance (accuracy)
Performance will be measured by children's accuracy (% trials correct) on symbolic number comparison task
Change from baseline in non-symbolic number comparison task performance (reaction time)
Performance will be measured by children's reaction time (milliseconds) on non-symbolic number comparison task
Change from baseline in non-symbolic number comparison task performance (accuracy)
Performance will be measured by children's accuracy (% trials correct) on non-symbolic number comparison task
Secondary outcomes
Change from baseline in symbolic addition task performance (reaction time)
Performance will be measured by children's reaction time (milliseconds) on symbolic addition task
Change from baseline in symbolic addition task performance (accuracy)
Performance will be measured by children's accuracy (% trials correct) on symbolic addition task
Sponsors and contacts
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Stanford University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator