Sleep Self-Management Intervention for Children With Juvenile Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): SLEEPSAMRT
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention model description: This pilot RCT, comparing usual care to SLEEPSMART intervention with 60 JIA children and their parents
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sleep deficiency, self-management