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

Phase 1

Completed

• Conditions: Juvenile Idiopathic Arthritis
• Interventions: Behavioral: Sleep Innovations for Preschoolers with Arthritis (SIPA)

• Registration Number: NCT04354337
• Lead Sponsor: University of Washington

Brief 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.

Study Timeline

• Study First Submitted: 2020-03-10
• Study First Submitted QC: 2020-04-16
• Study First Posted: 2020-04-21
• Study Start: 2020-05-01
• Primary Completion: 2021-03-20
• Study Completion: 2021-04-22
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Group	Sleep Innovations for Preschoolers with Arthritis (SIPA)	8-weeks online program with weekly modules for parents to learn about specific sleep topics and implement behavioral changes to improve their child's sleep.

Primary Outcome Measures

Name	Time	Method
Acceptability assessed by interview	immediately after intervention	investigators will invite participants to do an exit interview to describe their experience participating in the study.
Change in behavioral sleep problems	baseline; 8 weeks (immediately after intervention); and 3 months (study completion).	the Children's Sleep Wake Scale (CSWS) is a 25-item caregiver-report of child's behavioral sleep quality and includes five dimensions: going to bed, falling asleep, maintaining sleep, reinitiating sleep, and returning to wakefulness. Caregivers indicate how often their children have exhibited certain sleep behaviors during the last month via a 6-point scale (ranging from "never" to "always"). Total score ranges from 1-6, and higher scores means better sleep.
Feasibility as assessed by recruitment response rate and adherence rate	immediately after intervention	recruitment response rate and adherence rate will be calculated using percentages.
Usability rating assessed by System Usability Scale	baseline	usability of the intervention interfaces were tested before the pilot trial using the 10-item System Usability Scale (SUS). SUS total scores range from 10-100, and higher scores means better usability.

Secondary Outcome Measures

Name	Time	Method
Change in sleep duration measured by actigraphy	baseline; immediately after intervention; and 3 months (study completion).	actigraphy measured total sleep time
Change in sleep quality measured by actigraphy	baseline; immediately after intervention; and 3 months (study completion).	actigraphy measured sleep efficiency

Trial Locations

Locations (1)

University of washington; 🇺🇸 Seattle, Washington, United States