Juvenile Idiopathic Arthritis Clinical Trial
Official title:
Sleep Self-Management Intervention for Children With Juvenile Idiopathic Arthritis
Sleep deficiency is a public health concern in children with a chronic illness such as Juvenile Idiopathic Arthritis (JIA) because it is often overlooked in clinical care, attributed solely to the underlying chronic illness, and contributes to poor health outcomes. Development of an effective technology-based sleep self-management intervention has the potential to improve health outcomes of children living with JIA and their parents.
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 ;
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