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

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04354337
• Other study ID #: STUDY0008492
• Secondary ID: P30NR016585
• Status: Completed
• Phase: Phase 1
• Start date: May 1, 2020
• Est. completion date: April 22, 2021

Study information

• Verified date: May 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 22, 2021
• Est. primary completion date: March 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	University of washington	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by recruitment response rate and adherence rate	recruitment response rate and adherence rate will be calculated using percentages.	immediately after intervention
Primary	Acceptability assessed by interview	investigators will invite participants to do an exit interview to describe their experience participating in the study.	immediately after intervention
Primary	Usability rating assessed by System Usability Scale	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.	baseline
Primary	Change in behavioral sleep problems	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.	baseline; 8 weeks (immediately after intervention); and 3 months (study completion).
Secondary	Change in sleep duration measured by actigraphy	actigraphy measured total sleep time	baseline; immediately after intervention; and 3 months (study completion).
Secondary	Change in sleep quality measured by actigraphy	actigraphy measured sleep efficiency	baseline; immediately after intervention; and 3 months (study completion).

External Links

•   SIPA Website