Sleep Self-Management Intervention for Children With Juvenile Idiopathic Arthritis (SLEEPSMART)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
To develop and test a technology-based sleep self-management intervention delivered to 9-to-11 year-old children with JIA and their parents. The initial feasibility, acceptability, and efficacy of the newly developed sleep self-management intervention will be tested in a pilot randomized controlled trial comparing the active intervention against standard care with a sample of 60 children with JIA and their parents. Sleep will be measured using actigraphy, sleep diaries, & self-report measures. Problem-solving skills, motivation, beliefs about sleep, and sleep self-efficacy will be measured before and after the intervention. The long-term goal is to develop effective and low cost treatments to reduce sleep deficiency and the sleep-related health consequences among children with JIA. The specific aims are to:
Aim 1. Apply a user-centered design approach to develop and refine a technology-based sleep self-management intervention (SLEEPSMART). Direct stakeholder input will be obtained from children and parents about their needs for sleep shared-management as well as intervention material from our prior Web-based interventions for youth with chronic pain that includes sleep hygiene education, and a self-management focus (motivation, self-efficacy, patient activation) to develop content for the SLEEPSMART. Qualitative methods (iterative cycles of semi-structured audiotaped sessions with children and parents and think-aloud observation sessions by a trained observer) will be used to evaluate the usability of the SLEEPSMART prototype. Results of these analyses will guide program finalization.
Aim 2. Determine feasibility and initial efficacy of the SLEEPSMART with children with JIA in a pilot RCT. Study accrual and dropout rates will be assessed, as well as, levels of patient acceptability and engagement in a pilot randomized controlled trial (RCT) comparing usual care to SLEEPSMART intervention. Preliminary effect sizes of the SLEEPSMART will be determined in youth receiving treatment compared to usual care on primary outcomes of actigraphy sleep duration, sleep quality, and feasibility/acceptability, and secondary outcomes of child and parent self-management(activation, motivation, self-efficacy), technology use, recommendations for innovative sleep monitoring
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Washington
-
Seattle, Washington, Соединенные Штаты, 98195
- University of Washington School of Nursing
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria for Children:
- diagnosed with JIA
- 8-13 years
- able to read/speak English
- parent report that child has difficulties with sleep quality (difficulty falling asleep, no bedtime routine, waking up in the middle of the night and struggling to fall back asleep) and/or poor sleep impacts their child's day to day function (school, interacting with peers, hobbies).
Inclusion criteria for parents:
- > 18 years
- able to read/speak English.
Exclusion Criteria for Children:
- currently receiving
- lack of daily access to the Internet or mobile device as the study will be conducted online
- developmental delay
- child is not currently participating in psychological therapy.
Exclusion criteria for parents:
- diagnosed with a chronic illness that would interfere with ability to complete study procedures
- lack of daily access to the Internet or mobile device.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: SLEEPSMART PROGRAM
Arm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. Arm: Experimental -Each child and parent will create a login, choose treatment goals, and interact with fields in the Web site. The modules will focus on improving sleep hygiene, relaxation, or increasing sleep duration. The intervention will last 6 to 8 weeks. |
SLEEPSMART will be designed to improve sleep by providing guidance and structure to assist JIA children and their parent in adhering to the intervention protocol.
The intervention will be interactive and personalized; users will interface with three primary components:1) monitoring: daily records of sleep and symptoms; 2) skill building modules: sleep education, sleep skills training, relaxation techniques, positive coping skills, and reward systems for activity participation for reducing sleep deficiency; and 3) assignment review and personalized feedback via behavioral assignments for skill implementation and tailored feedback.
Modules will take an estimated 30 minutes each week to complete and will include multimedia elements to enhance learning.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
sleep quality
Временное ограничение: change from baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
|
Child Sleep Hygiene Scale- overall sleep hygiene score; 6-point scale; higher scores indicate better sleep hygiene.
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change from baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
|
|
self-efficacy
Временное ограничение: change from baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
|
Self-Efficacy scale: 9-item self-report of confidence in carrying out sleep-related behaviors; Likert scale from 1 (not at all confident) to 10 (totally confident); higher score indicates better self-efficacy.
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change from baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
|
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Usability of SLEEPSMART
Временное ограничение: 3 months at study completion
|
Semi-structured interviews will be conducted to assess their overall child and parent perceptions of the web-based program, the perceived usefulness and ease of use.
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3 months at study completion
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
sleep duration
Временное ограничение: change from baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
|
actigraphy total sleep time
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change from baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
|
|
acceptability of SLEEPSMART
Временное ограничение: 3 months at study completion
|
Parent and child survey about the likes and dislikes of the study protocol, areas for improvement, SLEEPSMART program and weekly assignments
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3 months at study completion
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Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Teresa M Ward, RN, PhD, University of Washington
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- STUDY00005070
- R21NR017471-01A1 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .