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

Phase

N/A

Condition

Joint Injuries

Arthritis And Arthritic Pain

Musculoskeletal Diseases

Treatment

Sleep Innovations for Preschoolers with Arthritis (SIPA)

Clinical Study ID

NCT04354337

STUDY00008492

P30NR016585

Ages 2-5
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria for children:

diagnosed with JIA
2-to-5 years
parent report of sleep problems or sleep less than 9 hours/day

Inclusion Criteria for parents:

>18 years
able to read/speak English

Exclusion Criteria for children:

diagnosed primary sleep disorder (e.g., obstructive sleep apnea)
positive screen on the Pediatric Sleep Questionnaire (> 0.33) for sleep-disordered breathing (investigators will suggest follow up with the child's primary care provider because treatment of this condition is beyond the scope this intervention)
developmental delay
co-morbid condition (asthma, diabetes)

Exclusion Criteria for parents:

nightshift work that would interfere with performing bedtime activities with children
diagnosed with a chronic illness that would interfere with completing study procedures
lack of daily access to the Internet or mobile device

Study Design

Sleep Innovations for Preschoolers with Arthritis (SIPA)

May 01, 2020

April 22, 2021

Study 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).

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.

Connect with a study center

University of washington
Seattle, Washington 98195
United States
Site Not Available

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