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

NCT04354337 | Completed Results

• 2 other identifiers: STUDY00008492P30NR016585
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Sleep deficiency; Self-management; Chronic disease

Outcome Measures

Primary Outcomes (2)

• Feasibility as Assessed by Adherence

  Adherence is calculated by the total number of dyads completing all intervention modules divided by the total number of dyads enrolled.

  immediately after intervention

• Children's Sleep Habits Questionnaire

  The Children's Sleep Habits Questionnaire (CSHQ) is a survey that assesses a child's sleep quality and quantity by asking parents to report on their child's sleep habits. The CSHQ has 45 items, including 33 scored questions and seven additional items. Parents rate each scored question on a three-point scale: usually, sometimes, and rarely. The total Sleep Disturbances score is calculated by adding up all the scored questions. All responses are totaled to create a Total Sleep Disturbance index (range from 33-99), with a score exceeding 41 suggesting the presence of a pediatric sleep disorder.

  baseline; 8 weeks (immediately after intervention); and 3 months (study completion).

Study Arms (1)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Sleep Innovations for Preschoolers with Arthritis (SIPA)

Interventions

Sleep Innovations for Preschoolers with Arthritis (SIPA) BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• diagnosed with JIA
• to-5 years
• parent report of sleep problems or sleep less than 9 hours/day
• \>18 years
• able to read/speak English

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of washington

Seattle, Washington, 98195, United States

Location

Related Links

• SIPA Website

MeSH Terms

Conditions

Arthritis, Juvenile; Chronic Disease

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Weichao Yuwen
• Organization: University of Washington

wyuwen@uw.edu

2536924478

Study Officials

• Weichao Yuwen, PhD, RN

  University of Washington- Tacoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Nursing

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: April 21, 2020
• Study Start: May 1, 2020
• Primary Completion: March 20, 2021
• Study Completion: April 22, 2021
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)