- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07778706
Intervention on Mathematical Problem-Solving Skills
20 augusti 2026 uppdaterad av: Vinod Menon, Stanford University
Interventions in Math Learning Disabilities: Cognitive and Neural Correlates
The purpose of this study is to investigate neurocognitive mechanisms underlying response to intervention aimed at enhancing and remediating weaknesses in arithmetic skills in children, including those with mathematical learning disabilities.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
160
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
Palo Alto, California, Förenta staterna, 94304
- Stanford University
-
Huvudutredare:
- Vinod Menon, Ph.D.
-
Kontakt:
- Zehra E Unal, Ph.D.
- Telefonnummer: 7376150834
- E-post: zehraeu@stanford.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Elementary school-aged children starting from first grade (6-12 years old)
- Intelligence Quotient: Participants with a Full Scale Intelligence Quotient is greater than 70 on the Wechsler Abbreviated Scale of Intelligence Quotient
- Identification of Mathematical Learning Disabilities: Scores below the 20th percentile on two or more Wechsler Individual Achievement Test, Fourth Edition math subtests
- Identification of typically developing children: Scores at or above the 50th percentile on two or more Wechsler Individual Achievement Test, Fourth Edition 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 magnetic resonance imaging scan session: No major contraindication for magnetic resonance imaging (braces, metal implants, pacemakers, vascular stents, metallic ear tubes, consistent exposure to metal, or claustrophobia)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arithmetic strategy training
Participants complete 6 weeks of activities, 1-hour hybrid sessions daily for 3 days per week (in total 18 sessions), that progressively develop the efficient use of arithmetic problem-solving strategies.
Before and after training, participants complete arithmetic problem-solving tasks during neuroimaging sessions.
|
Arithmetic strategy training includes activities that progressively develop the efficient use of arithmetic problem-solving strategies.
|
|
Aktiv komparator: Speeded practice training
Participants complete 6 weeks of activities, 1-hour hybrid sessions daily for 3 days per week (in total 18 sessions), that focus solely on enhancing arithmetic fluency.
Before and after training, participants complete arithmetic problem-solving tasks during neuroimaging sessions.
|
Speeded practice training includes activities that focus solely on enhancing arithmetic fluency.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in arithmetic task performance (reaction time)
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Performance will be measured by children's reaction time (milliseconds) on arithmetic task
|
Baseline and post-intervention (after 6 weeks)
|
|
Change from baseline in arithmetic task performance (accuracy)
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Performance will be measured by children's accuracy (% trials correct) on arithmetic task
|
Baseline and post-intervention (after 6 weeks)
|
|
Change from baseline in latent cognitive measures of arithmetic task performance (drift rate)
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Latent cognitive processing will be measured by drift rate from children's arithmetic task performance
|
Baseline and post-intervention (after 6 weeks)
|
|
Change from baseline in latent cognitive measures of arithmetic performance (post-error adjustment)
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Latent cognitive processing will be measured by post-error adjustment from children's arithmetic task performance
|
Baseline and post-intervention (after 6 weeks)
|
|
Change from baseline in brain activation during arithmetic task performance
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Neural activity will be measured during a functional magnetic resonance imaging arithmetic task.
Data will consist of beta values from individual-subject contrast maps for the Small vs. Large contrast in the whole-brain general linear modeling functional magnetic resonance imaging analysis.
|
Baseline and post-intervention (after 6 weeks)
|
|
Change from baseline in brain representation during arithmetic task performance
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Neural activity will be measured during the functional magnetic resonance imaging arithmetic task.
Data will consist of spatial correlations of voxel-wise brain activation between Trained vs. Rest and Untrained vs. Rest contrasts for individual subjects.
|
Baseline and post-intervention (after 6 weeks)
|
|
Change from baseline in brain connectivity during arithmetic task performance
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Neural activity will be measured during the functional magnetic resonance imaging arithmetic task. Data will consist of generalized psychophysiological interaction beta values from individual subject contrast maps for Small vs. Large contrast. |
Baseline and post-intervention (after 6 weeks)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline in untrained arithmetic task performance (reaction time)
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Performance will be measured by children's reaction time (milliseconds) on untrained arithmetic task
|
Baseline and post-intervention (after 6 weeks)
|
|
Change from baseline in untrained arithmetic task performance (accuracy)
Tidsram: Baseline and post-intervention (after 6 weeks)
|
Performance will be measured by children's accuracy (% trials correct) on untrained arithmetic task
|
Baseline and post-intervention (after 6 weeks)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Vinod Menon, Ph.D., Stanford University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 september 2026
Primärt slutförande (Beräknad)
1 september 2031
Avslutad studie (Beräknad)
1 september 2031
Studieregistreringsdatum
Först inskickad
18 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
18 augusti 2026
Första postat (Faktisk)
21 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
24 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
20 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 87897
- R01HD059205 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .