Brain Uptrain to Improve Learning and Development
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: Coach-led caregiver-implemented early literacy and developmental programming, Reach Out and Read Training.
- Кому может быть актуально
- Состояния в реестре: Term Infant, Late Preterm Infant. Базовые параметры: 1 Day — 7 Days · 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 →
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Официальное название
Brain Uptrain to Improve Learning and Development: A Randomized Clinical Trial
Обзор
The purpose of this study is to see if an early literacy and developmental program in addition to shared reading can increase developmental test scores at 24 months of age. All caregivers of infants in this study will receive shared reading training. Half of the caregivers will be trained in an additional coach-led caregiver-implemented early literacy and numeracy program. Information related to infant development will be collected from parent surveys, medical records, and questionnaires and assessments.
Подробное описание
This study will test the hypothesis that in term or late preterm infants who are discharged home from the newborn nursery, a coach-led caregiver-implemented early literacy and developmental program in addition to shared reading, compared with shared reading alone, will increase the Ages and Stages Questionnaire® score at 24 months. This will be a double blind randomized controlled trial with 1:1 parallel allocation using stratified permuted block design. Randomization will be stratified by gestational age (≥ 35 to \<38 weeks and ≥ 38 weeks). Randomization of twins and higher orders (when eligible) will be to the same group. Term and late preterm infants ≥ 35 weeks' gestation admitted to the newborn nursery are eligible for inclusion if they are being discharged home. We will exclude infants admitted to the NICU, infants with a known syndrome or major malformation, infants in DHR custody, infants enrolled in a competing study, and infants of families with a primary language other than English or Spanish. All study participants will receive shared reading information at scheduled well-child checks. Caregivers of infants in the intervention group will receive additional coach-led caregiver-implemented early literacy and developmental program. We will complete an ASQ-3 online or by telephone at 12 months, 24 months, and 36 months. We will also measure early literacy at 3 years, 4 years, and 5 years. The primary outcome will be the ASQ-3 scores at 24 months.
Вмешательства
- Поведенческое Coach-led caregiver-implemented early literacy and developmental programming
Caregivers will receive training about child brain development in the first 3 years of life. The training will emphasize the areas of spoken words, physical education, pointer-finger concept, focus and label, reading lessons, and mathematics. - Поведенческое Reach Out and Read Training
Reach Out and Read parent training
Первичные конечные точки
- ASQ-3 scores [Срок оценки: 24 month well-child visit]
Вторичные конечные точки (12)
- ASQ-3 scores [Срок оценки: 12 month well-child visit]
- ASQ-3 scores [Срок оценки: 36 month well-child visit]
- ASQ scores below -2SD [Срок оценки: 12 month well-child visit]
- ASQ scores below -2SD [Срок оценки: 24 month well-child visit]
- ASQ scores below -2SD [Срок оценки: 36 month well-child visit]
- ASQ scores below -1SD [Срок оценки: 12 month well-child visit]
- ASQ scores below -1SD [Срок оценки: 24 month well-child visit]
- ASQ scores below -1SD [Срок оценки: 36 month well-child visit]
- Literacy Scores [Срок оценки: 36 months]
- Literacy Scores [Срок оценки: 48 months]
- Literacy Scores [Срок оценки: 60 months]
- Kindergarten Readiness [Срок оценки: 60 months]
Критерии участия
Inclusion Criteria: inborn at UAB, delivered at more than 35 weeks' gestation, planned for discharge home after initial hospitalization.
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Exclusion Criteria: a major malformation, a known syndrome, admitted to the NICU, in DHR custody, enrolled in a competing study, and family's primary language is other than English or Spanish.
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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Тройное слепое
- Основная цель
- Другое
Центры проведения
США · 1 центр
- University of Alabama at Birmingham — Birmingham
Идентификаторы
NCT: NCT06638801 · IRB-300013307 · UAB