Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 1

Summary: 
      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.
    

Detailed description: 
      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).

      2. 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.
    

Intervention name(s): Sleep Innovations for Preschoolers with Arthritis (SIPA)
Intervention type(s): Behavioral
Intervention description(s): The SIPA intervention is interactive and personalized. Every week, parent will receive an email sent automatically through the system with instructions for this week's activity, designed to take about 30 minutes to complete. The SIPA weekly modules will begin with a learning module, then direct participants through goal setting, anticipated barriers, and problem solving. The intervention site will include fillable responses to queries, instructions, and assignments. Tasks for parents and their young children will use multimedia elements to enhance delivery of information, such as links to videos and pictures targeting self-efficacy, motivation, and patient activation. Submissions and progress will be monitored by the study team, who will send email, call or text with reminders (whichever the family prefers) and answer questions as needed, review progress, and help problem solve any technology issues or barriers to implementing skills.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep deficiency; Self-management; Chronic disease