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Идёт набор NCT05201534

Interventions in Mathematics and Cognitive Skills

Без фазы С лечением Math Learning Disability Child Development Developmental Disability Learning Disabilities

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Interventions in Mathematics and Cognitive Skills - Experimental, Interventions in Mathematics and Cognitive Skills - Active Comparator.
Кому может быть актуально
Состояния в реестре: Math Learning Disability, Child Development, Developmental Disability, Learning Disabilities. Базовые параметры: 6 лет — 12 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Interventions in Math Learning Disabilities: Cognitive and Neural Correlates

Обзор

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).

Подробное описание

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.

Вмешательства

  • Другое 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
  • Другое Interventions in Mathematics and Cognitive Skills - Active Comparator
    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

Первичные конечные точки

  • Change from baseline in symbolic number comparison task performance (reaction time) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in symbolic number comparison task performance (accuracy) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in non-symbolic number comparison task performance (reaction time) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in non-symbolic number comparison task performance (accuracy) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of symbolic number comparison task performance (drift rate) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of symbolic number comparison task performance (post-error adjustment) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (drift rate) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in latent cognitive measures of non-symbolic number comparison task performance (post-error adjustment) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in brain activation during symbolic number comparison task performance [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in brain activation during non-symbolic number comparison task performance [Срок оценки: Baseline and post-intervention (after 6 weeks)]
Вторичные конечные точки (2)
  • Change from baseline in symbolic addition task performance (reaction time) [Срок оценки: Baseline and post-intervention (after 6 weeks)]
  • Change from baseline in symbolic addition task performance (accuracy) [Срок оценки: Baseline and post-intervention (after 6 weeks)]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Stanford Cognitive and Systems Neuroscience Laboratory — Palo Alto

Идентификаторы

NCT: NCT05201534 · 62479 · 2R01HD059205-11A1 · SPO #42749

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗