Interventions in Mathematics and Cognitive Skills

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorStanford University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Interventions in Mathematics and Cognitive Skills - Experimental

    Other intervention

    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 in Mathematics and Cognitive Skills - Active Comparator

    Other intervention

    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.

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: Integrative Symbolic Non-Symbolic (iSNS) TrainingExperimental treatment 1 intervention
Group B: Active Comparator: Active Control Intervention (Working Memory Training)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline and post-intervention (after 6 weeks)
2

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

Time frame
Baseline and post-intervention (after 6 weeks)
3

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

Time frame
Baseline and post-intervention (after 6 weeks)
4

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

Time frame
Baseline and post-intervention (after 6 weeks)

Secondary outcomes

1

Change from baseline in symbolic addition task performance (reaction time)

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

Time frame
Baseline and post-intervention (after 6 weeks)
2

Change from baseline in symbolic addition task performance (accuracy)

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

Time frame
Baseline and post-intervention (after 6 weeks)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

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

Collaborator