Interventions in Mathematics and Cognitive Skills (NCT05201534) | Clinical Trial Compass
RecruitingNot Applicable
Interventions in Mathematics and Cognitive Skills
United States180 participantsStarted 2023-05-05
Plain-language 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).
Who can participate
Age range
6 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline in symbolic number comparison task performance (reaction time)
Timeframe: Baseline and post-intervention (after 6 weeks)
2
Change from baseline in symbolic number comparison task performance (accuracy)
Timeframe: Baseline and post-intervention (after 6 weeks)
3
Change from baseline in non-symbolic number comparison task performance (reaction time)
Timeframe: Baseline and post-intervention (after 6 weeks)
4
Change from baseline in non-symbolic number comparison task performance (accuracy)
Timeframe: Baseline and post-intervention (after 6 weeks)
5
Change from baseline in latent cognitive measures of symbolic number comparison task performance (drift rate)
Timeframe: Baseline and post-intervention (after 6 weeks)
6
Change from baseline in latent cognitive measures of symbolic number comparison task performance (post-error adjustment)
Timeframe: Baseline and post-intervention (after 6 weeks)
. 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)
Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (drift rate)
Timeframe: Baseline and post-intervention (after 6 weeks)
8
Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (post-error adjustment)
Timeframe: Baseline and post-intervention (after 6 weeks)
9
Change from baseline in brain activation during symbolic number comparison task performance
Timeframe: Baseline and post-intervention (after 6 weeks)
10
Change from baseline in brain activation during non-symbolic number comparison task performance
Timeframe: Baseline and post-intervention (after 6 weeks)