Juvenile Idiopathic ArthritisNCT04354337
Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention
A study testing Sleep Innovations for Preschoolers with Arthritis (SIPA) in people with Juvenile Idiopathic Arthritis, run by University of Washington at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Sleep Innovations for Preschoolers with Arthritis (SIPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 22 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed with JIA
- 2-to-5 years
- parent report of sleep problems or sleep less than 9 hours/day
- >18 years
- able to read/speak English
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Testing the Usability and Feasibility of a Self-Management Intervention
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.
Read the 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).
- 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.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Sleep Innovations for Preschoolers with Arthritis (SIPA)
- Keywords
- Sleep deficiency, Self-management, Chronic disease
- Medical subject headings
- Arthritis, Juvenile, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Innovations for Preschoolers with Arthritis (SIPA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Innovations for Preschoolers with Arthritis (SIPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: baseline; 8 weeks (immediately after intervention); and 3 months (study completion).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 May 2020
- Primary completion20 Mar 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Weichao Yuwen, University of Washington
- Investigators
- Weichao Yuwen, PhD, RN, Principal investigator, University of Washington- Tacoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354337
- Sponsor's protocol ID
- STUDY00008492
- Other IDs
- P30NR016585
- Status last verified
- Feb 2025
- First submitted
- 10 Mar 2020
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Testing the Usability and Feasibility of a Self-Management Intervention
- ClinicalTrials.gov ID
- NCT04354337
- Acronym / sponsor ID
- STUDY00008492
- Conditions
- Juvenile Idiopathic Arthritis
- Keywords
- Sleep deficiency, Self-management, Chronic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 May 2020 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Posted 10 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Sleep Innovations for Preschoolers with Arthritis (SIPA)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. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- diagnosed with JIA
- 2-to-5 years
- parent report of sleep problems or sleep less than 9 hours/day
- >18 years
- able to read/speak English
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Group |
Primary outcome
Feasibility as Assessed by Adherence
Time frame: immediately after intervention
Adherence is calculated by the total number of dyads completing all intervention modules divided by the total number of dyads enrolled.
Children's Sleep Habits Questionnaire
Time frame: baseline; 8 weeks (immediately after intervention); and 3 months (study completion).
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- SIPA WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weichao Yuwen, PhD, RN principal investigator
University of Washington- Tacoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Innovations for Preschoolers with Arthritis (SIPA) in people with Juvenile Idiopathic Arthritis, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility as Assessed by Adherence (time frame: immediately after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.