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Идёт набор NCT06618040

Bedtime Stories: Tailored Sleep Health Messaging for Caregivers

Без фазы С лечением Sleep Health-Related Behavior

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: Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C).
Кому может быть актуально
Состояния в реестре: Sleep, Health-Related Behavior. Базовые параметры: от 18 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 →

Обзор

To date, there are very few established sleep health education models targeting caregivers of school-aged children from historically marginalized and/or low income communities. To address this significant gap, this project seeks to examine the feasibility, acceptability, and usability of the Bedtime Stories Sleep Health Education Program to improve sleep behavior. Bedtime Stories is a multi-stakeholder (health care providers, school-aged children, and caregivers of school-aged children) and a multi-component program. The caregiver component of the program utilizes mobile health technology with targeted and tailored sleep health messaging for caregivers of school-aged children. Addressing these aims will help to mitigate gaps in the delivery of health care services to caregivers and families in low income and historically marginalized communities, where services and interventions are scant.

Подробное описание

Healthy sleep practices are a fundamental component of sleep education interventions designed to prevent sleep problems from developing (Masten et al., 2006) and aide in managing existing sleep disorders such as insomnia in children (Moore et al., 2007). Although poor sleep is linked to a host of negative outcomes, sleep health may also be viewed in a positive light, i.e., "sleep wellness" that places the emphasis on the benefits of good sleep and its importance to overall health maintenance and improvement. Indeed, both the positive and negative aspects of sleep are highly relevant with regards to developing sleep health educational programs, while providing concrete targets for health promotion, wellness and prevention. Fostering healthy sleep habits in children and adolescents builds the foundation for healthy sleep habits in adulthood (Galland et al., 2010). A major challenge to identifying sleep concerns in children is that identification often relies on parent reported concerns, professional clinical judgment, and the presence of symptomatology that changes with age. The early diagnosis of sleep concerns is a key factor to enable access to interventions that improve sleep health. To address this critical gap requires targeted interventions tailored to healthcare providers, particularly those serving communities and populations most in need.

Interventions for caregivers focused on sleep health, including sleep health practice, building and supporting routines, and consistent sleep schedules are integral features to sleep. Settings to promote healthy sleep practices including well-child visits. The well-child visit is an opportunity to educate parents about normal sleep in children and provide strategies to prevent sleep problems from either developing, or if problems already exist from becoming chronic. Community health centers which serve both children and adults, afford unique opportunities to incorporate screening and the prevention of sleep disorders; and deliver coordinated health messages to parents and children in order to effect positive behavioral change within the entire family.

Вмешательства

  • Поведенческое Bedtime Stories Sleep Health Education Program for Caregivers (BTS-C)
    The BTS-C includes 6 educational modules on different topics related to sleep health: principles of healthy sleep practices include sleep routines, the sleep environment, considerations for screen time, timing of sleep and activities surrounding sleep, expectations for healthy sleep and sleep duration. Caregivers will also receive a combination of tailored messages or prompts to explore progress, identify strategies for change, and goal setting.

Первичные конечные точки

  • Knowledge, Perceptions, and Practices [Срок оценки: Follow Up, after 8 weeks]
  • Feasibility, acceptability, and usability [Срок оценки: Follow Up, after 8 weeks]
  • Assessment of Child Sleep [Срок оценки: 1 week baseline, 1 week follow up, entire study]
  • Child Sleep Health [Срок оценки: Baseline (at week 0), Follow Up (after 8 weeks)]
Вторичные конечные точки (4)
  • Child Sleep Environment [Срок оценки: Baseline (at week 0)]
  • Child Sleep Disturbance Impairments [Срок оценки: Baseline (at week 0), Follow Up (after 8 weeks)]
  • Assessment of parent/caregiver sleep [Срок оценки: Baseline (at week 0), Follow Up (after 8 weeks), Entire Study (8 weeks)]
  • Caregiver Stress [Срок оценки: Baseline (at week 0), Follow Up (after 8 weeks)]

Критерии участия

Критерии включения

  • 18 years old or over
  • Caregivers of school-aged children (5-11 years of age) that receive care at participating community healthcare centers in the Boston area
  • English fluency

Критерии исключения

  • Planning on moving within the next 3 months
  • Does not live in the home with the child

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

США · 1 центр
  • Boston Children's Hospital — Boston

Публикации

  • Mindell JA, Bartle A, Wahab NA, Ahn Y, Ramamurthy MB, Huong HT, Kohyama J, Ruangdaraganon N, Sekartini R, Teng A, Goh DY. Sleep education in medical school curriculum: a glimpse across countries. Sleep Med. 2011 Oct;12(9):928-31. doi: 10.1016/j.sleep.2011.07.001. Epub 2011 Sep 16. PMID 21924951
  • Owens JA, Jones C. Parental knowledge of healthy sleep in young children: results of a primary care clinic survey. J Dev Behav Pediatr. 2011 Jul-Aug;32(6):447-53. doi: 10.1097/DBP.0b013e31821bd20b. PMID 21546852

Идентификаторы

NCT: NCT06618040 · IRB-P00047237

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗