Clinical trial NCT04354337: Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention
Official title: Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Testing the Usability and Feasibility of a Self-Management Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Sleep deficiency
Self-management
Chronic disease
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2020-04-21
Enrollment: 16
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility as Assessed by Adherence
timeFrame: immediately after intervention
measure: Children's Sleep Habits Questionnaire
timeFrame: baseline; 8 weeks (immediately after intervention); and 3 months (study completion).
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of washington
state: Washington
Study officials:
affiliation: University of Washington- Tacoma
name: Weichao Yuwen, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: