Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Testing the Usability and Feasibility of a Self-Management Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Feasibility as Assessed by Adherence
研究概览
简要总结
Behavioral sleep problems such as sleep onset delays and frequent night wakings are common among young children (2-5 years). Children with a chronic health condition such as juvenile idiopathic arthritis (JIA) are even more prone to sleep problems, which are also associated with disease-related symptoms such as pain and fatigue. Early childhood is a critical period for establishing healthy sleep habits and self-regulation skills and is therefore an opportune time to identify and address unhealthy sleep habits. The Sleep Innovation for Preschoolers with Arthritis (SIPA) project will develop and pilot test a technology-based sleep intervention for parents of young children with JIA.
详细描述
The SIPA study aims to develop and test the usability, feasibility, acceptability, and preliminary effectiveness of a technology-based sleep intervention - Sleep Innovation for Preschoolers with Arthritis (SIPA) - that provides JIA parents with the necessary tools (self-efficacy, motivation, activation) to set goals, problem solve, and improve sleep in young children with JIA. SIPA will address the causes of sleep deficiency including behavioral sleep problems (e.g., sleep onset delay, frequent night awakenings, and sleep onset association disorder) in preschoolers with JIA using a single-arm pre- and post-test pilot study. Investigators will pilot test the intervention with 18 parents and preschoolers with JIA. Investigators will assess the feasibility and acceptability of the intervention among users, as will as analyze its preliminary effectiveness in terms of changes in behavioral sleep problems in the preschoolers pre- and post-intervention. The specific aims are to:
Aim 1. Apply a user-centered iterative design approach to develop and test the usability of a technology- based sleep self-management intervention - Sleep Innovation for Preschoolers with Arthritis (SIPA) - for 2-5-year-old children (preschoolers) with juvenile idiopathic arthritis (JIA).
- Describe the feasibility, acceptability, and preliminary effectiveness of the SIPA intervention to address the causes of behavioral sleep problems (e.g., frequent night awakenings, and sleep onset association disorder) that are the main cause of sleep deficiency in preschoolers with JIA using a single-arm pre- and post-test pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Feasibility as Assessed by Adherence
时间窗: immediately after intervention
Adherence is calculated by the total number of dyads completing all intervention modules divided by the total number of dyads enrolled.
Children's Sleep Habits Questionnaire
时间窗: baseline; 8 weeks (immediately after intervention); and 3 months (study completion).
The Children's Sleep Habits Questionnaire (CSHQ) is a survey that assesses a child's sleep quality and quantity by asking parents to report on their child's sleep habits. The CSHQ has 45 items, including 33 scored questions and seven additional items. Parents rate each scored question on a three-point scale: usually, sometimes, and rarely. The total Sleep Disturbances score is calculated by adding up all the scored questions. All responses are totaled to create a Total Sleep Disturbance index (range from 33-99), with a score exceeding 41 suggesting the presence of a pediatric sleep disorder.
次要结局
未报告次要终点
研究者
Weichao Yuwen
Assistant Professor, School of Nursing
University of Washington