- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04354337
Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention
Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Testing the Usability and Feasibility of a Self-Management Intervention
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98195
- University of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Intervention Group
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility as assessed by recruitment response rate and adherence rate
Time Frame: immediately after intervention
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recruitment response rate and adherence rate will be calculated using percentages.
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immediately after intervention
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Acceptability assessed by interview
Time Frame: immediately after intervention
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investigators will invite participants to do an exit interview to describe their experience participating in the study.
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immediately after intervention
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Usability rating assessed by System Usability Scale
Time Frame: baseline
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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.
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baseline
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Change in behavioral sleep problems
Time Frame: baseline; 8 weeks (immediately after intervention); and 3 months (study completion).
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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.
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baseline; 8 weeks (immediately after intervention); and 3 months (study completion).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in sleep duration measured by actigraphy
Time Frame: baseline; immediately after intervention; and 3 months (study completion).
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actigraphy measured total sleep time
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baseline; immediately after intervention; and 3 months (study completion).
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Change in sleep quality measured by actigraphy
Time Frame: baseline; immediately after intervention; and 3 months (study completion).
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actigraphy measured sleep efficiency
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baseline; immediately after intervention; and 3 months (study completion).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Weichao Yuwen, PhD, RN, University of Washington- Tacoma
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY0008492
- P30NR016585 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of SaskatchewanSaskatchewan Health Research FoundationCompleted
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