NCT04354337

Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention

Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Testing the Usability and Feasibility of a Self-Management Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 2 Years – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
BEHAVIORAL	Sleep Innovations for Preschoolers with Arthritis (SIPA)	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.

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-03-20
• Completion: 2021-04-22
• First posted: 2020-04-21
• Last updated: 2025-03-10
• Results posted: 2025-03-10

Locations

1 site across 1 country: United States