Juvenile Idiopathic ArthritisSLEEPSMARTNCT04066205

Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis

A study testing SLEEPSAMRT in people with Juvenile Idiopathic Arthritis, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 8 to 13 years
Conditions the study is for: Juvenile Idiopathic Arthritis
What is being tested?: SLEEPSAMRT
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2019to 20 May 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 8 to 13 years
All sexes
No healthy volunteers
Child

Who may be able to join

diagnosed with JIA, 8-13 years, and parent report that child has difficulties with sleep quality (difficulty falling asleep, no bedtime routine, waking up in the middle of the night and struggling to fall back asleep) and/or poor sleep impacts their child's day to day function (school, interacting with peers, hobbies).
> 18 years, access to a computer or web-based device to complete the surveys, and residing with the child more than 50% of the time

Who cannot join

Diagnosed with a sleep disorder (OSA), positive screen on the pediatric sleep questionnaire for OSA, lack of daily access to the internet, developmental delay, currently taking sleep medication (melatonin), and currently participating in psychological therapy and/or participated in psychological therapy the prior 3 months.
diagnosed with a chronic illness that would interfere with ability to complete study procedures

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Washington School of Nursing
Seattle, Washington, 98195

Other trials in United States

About this study

Sleep deficiency is a public health concern in children with a chronic illness such as Juvenile Idiopathic Arthritis (JIA) because it is often overlooked in clinical care, attributed to the underlying chronic illness, and contributes to poor health outcomes. Development of an effective technology-based sleep shared-management intervention that integrate children and parents in the co-design and development of the intervention has the potential to improve health outcomes of children living with JIA and their parents.

Read the detailed description

To develop and test a technology-based sleep shared-management intervention delivered to 8-to-13 year-old children with JIA and their parents. The initial feasibility, acceptability, and efficacy of the newly developed sleep shared-management intervention will be tested in a pilot randomized controlled trial comparing the active intervention against standard care with a sample of 60 children with JIA and their parents. Sleep will be measured using actigraphy, sleep diaries, \& self-report measures. Self-efficacy will be measured before and after the intervention. The long-term goal is to develop effective and low cost treatments to reduce sleep deficiency and the sleep-related health consequences among children with JIA. The specific aims are to:

Aim 1. Apply a human-centered design approach to develop and refine a technology-based sleep shared-management intervention (SLEEPSMART). Direct stakeholder input will be obtained from children and parents about their needs for sleep shared-management as well as intervention material adapted from the Transdiagnostic Sleep-Circadian Dysfunction program for youth that includes four cross cutting components (sleep complaint, education, behavior change and motivation, and goal setting) across the modules and a shared- management focus (motivation, self-efficacy) with children and parent partnering together to improve sleep. Qualitative methods (iterative cycles of semi-structured audiotaped sessions with children and parents and think-aloud observation sessions by a trained observer) will be used to evaluate the usability of the SLEEPSMART prototype. Results of these analyses will guide program finalization.

Aim 2. Determine feasibility and initial efficacy of the SLEEPSMART with children with JIA in a pilot RCT. Study accrual and dropout rates will be assessed, as well as, levels of patient acceptability and engagement in a pilot randomized controlled trial (RCT) comparing usual care to SLEEPSMART intervention. Preliminary effect sizes of the SLEEPSMART will be determined in youth receiving treatment compared to usual care on primary outcomes of actigraphy sleep duration, self-report sleep disturbances, and feasibility/acceptability, and secondary outcomes include self-efficacy.

Conditions: Juvenile Idiopathic Arthritis
Being tested: SLEEPSAMRT
Keywords: Sleep deficiency, self-management
Medical subject headings: Arthritis, Juvenile

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SLEEPSAMRTBehavioural
SLEEPSMART is a web-based intervention that adapted and modified components from the Transdiagnostic Sleep and Circadian intervention for youth and included four cross-cutting components (sleep complaint, education, behavior change and motivation, and goal-setting) that were integrated into each module. To begin the intervention, participants were provided a link to the SLEEPSMART intervention website for one of the above modules and an online sleep coach each week. At the end of each week, children and parents uploaded the weekly activities and goals via the REDCap link and set up a meeting with the sleep coach to review. The modules took 20 to 30 minutes to complete.

Study groups in NCT04066205
Study group	Role	What they receive
SLEEPSMART PROGRAM	Experimental	Arm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. Arm: Experimental -Each child and parent dyad will work together to create sleep goals, problem solve and compromise to accomplish the goals, and interact with fields in the Web site. The modules will focus on learning a wind-down and wake-up routine, reducing time in bed, reducing sleep-related worry, negotiating sleep in the environment, correcting unhelpful sleep-related beliefs, and sleep maintenance and relapse prevention. The intervention will last 7 weeks. Receives: Behavioral: SLEEPSAMRT

What is being measured

The primary outcome is the main question the study is designed to answer.

Sleep Disturbance
PROMIS Sleep Disturbance an 8-item questionnaire that measures self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Items are rated on a 5-point Likert scale (1= not at all/very poor, 2 = a little bit/poor, 3=somewhat/fair, 4=quite a bit/good, 5= very much/very good). The raw scores are converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores suggest more disturbed sleep.
Measured: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
Sleep Efficiency
Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep.
Measured: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
Sleep Duration
Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period;
Measured: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Acceptability of SLEEPSMART
Parent and child survey about the likes and dislikes of the study protocol, areas for improvement, SLEEPSMART program and weekly assignments. Items are scored using a 5-point scale, with 1 equalling strongly disagree and 5 equalling strongly agree. Scores can range from 9 to 45 with higher scores representing greater acceptance. A total score of moderate acceptability for the nine items would be 27.
Measured: 3 months at study completion

Secondary outcomes (2)

Self-efficacy Child
Self-Efficacy scale: 9-item self-report of confidence in carrying out sleep-related behaviors; Likert scale from 1 (not at all confident) to 10 (totally confident); higher score indicates better self-efficacy.
Measured: Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Self-efficacy Parent
A 9-item survey that assesses parent confidence to manage/control their children's chronic conditions and sleep, emotional functioning, and communication with healthcare providers. Items are rated using a visual analog scale, ranging from 1 = not at all confident to 10 = totally confident. A mean score is calculated with higher values indicative of higher self-efficacy
Measured: baseline (start of the study); 2 months (immediately after the 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.

1 Nov 201920 May 2021

First posted26 Aug 2019
Study start1 Nov 2019
Primary completion3 Mar 2021
Study completion20 May 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.
Publications (1)Papers the sponsor has linked to this study.
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: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: This pilot RCT, comparing usual care to SLEEPSMART intervention with 60 JIA children and their parents
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04066205
Sponsor's protocol ID: STUDY00005070
Other IDs: R21NR017471-01A1
Acronym: SLEEPSMART
Status last verified: Dec 2024
First submitted: 5 Sep 2018
Last updated: 8 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhai S, Palermo TM, Shenoi S, Demiris G, Howard W, Kientz J, Yuwen W, Ward TM. A shared-management web-based intervention for sleep deficiency in school-age children with juvenile idiopathic arthritis and their parents: feasibility and acceptability study. J Clin Sleep Med. 2025 Jun;21(6):1007-1021. doi: 10.5664/jcsm.11610. Epub 2025 Jun 1.
PubMed 40051205

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Juvenile Idiopathic Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis
ClinicalTrials.gov ID: NCT04066205
Acronym / sponsor ID: SLEEPSMART / STUDY00005070
Conditions: Juvenile Idiopathic Arthritis
Keywords: Sleep deficiency, self-management
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 1 Nov 2019 (actual)
Primary completion: 3 Mar 2021 (actual)
Study completion: 20 May 2021 (actual)
First posted: 26 Aug 2019 (actual)
Results: Posted 8 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This pilot RCT, comparing usual care to SLEEPSMART intervention with 60 JIA children and their parents

Arm	Type	Receives
SLEEPSMART PROGRAM	Experimental	Behavioral: SLEEPSAMRTArm: Placebo Comparator (Usual care)-This treatment arm will receive usual JIA care, including annual Rheumatology clinic visits, medications, routine clinical and laboratory tests, physical therapy, follow-up appointments, and no sleep intervention. Arm: Experimental -Each child and parent dyad will work together to create sleep goals, problem solve and compromise to accomplish the goals, and interact with fields in the Web site. The modules will focus on learning a wind-down and wake-up routine, reducing time in bed, reducing sleep-related worry, negotiating sleep in the environment, correcting unhelpful sleep-related beliefs, and sleep maintenance and relapse prevention. The intervention will last 7 weeks.

Who may qualify

Ages: 8 to 13 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

diagnosed with JIA, 8-13 years, and parent report that child has difficulties with sleep quality (difficulty falling asleep, no bedtime routine, waking up in the middle of the night and struggling to fall back asleep) and/or poor sleep impacts their child's day to day function (school, interacting with peers, hobbies).
> 18 years, access to a computer or web-based device to complete the surveys, and residing with the child more than 50% of the time

Key exclusion criteria (2 listed)

Diagnosed with a sleep disorder (OSA), positive screen on the pediatric sleep questionnaire for OSA, lack of daily access to the internet, developmental delay, currently taking sleep medication (melatonin), and currently participating in psychological therapy and/or participated in psychological therapy the prior 3 months.
diagnosed with a chronic illness that would interfere with ability to complete study procedures

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
SLEEPSAMRTSLEEPSMART is a web-based intervention that adapted and modified components from the Transdiagnostic Sleep and Circadian intervention for youth and included four cross-cutting components (sleep complaint, education, behavior change and motivation, and goal-setting) that were integrated into each module. To begin the intervention, participants were provided a link to the SLEEPSMART intervention website for one of the above modules and an online sleep coach each week. At the end of each week, children and parents uploaded the weekly activities and goals via the REDCap link and set up a meeting with the sleep coach to review. The modules took 20 to 30 minutes to complete.	Behavioural	SLEEPSMART PROGRAM

Primary outcome

Sleep Disturbance
Time frame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
PROMIS Sleep Disturbance an 8-item questionnaire that measures self-reported perceptions of sleep quality, depth, and restoration within the past seven days. Items are rated on a 5-point Likert scale (1= not at all/very poor, 2 = a little bit/poor, 3=somewhat/fair, 4=quite a bit/good, 5= very much/very good). The raw scores are converted into a T-score. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Higher T-scores suggest more disturbed sleep.
Sleep Efficiency
Time frame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
Actigraphy variable defined as the ratio of total sleep time/time in bed where 1.0 is the most efficient sleep.
Sleep Duration
Time frame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Actigraphy variable Total Sleep Time (TST), defined as the minutes during the sleep period;
Acceptability of SLEEPSMART
Time frame: 3 months at study completion
Parent and child survey about the likes and dislikes of the study protocol, areas for improvement, SLEEPSMART program and weekly assignments. Items are scored using a 5-point scale, with 1 equalling strongly disagree and 5 equalling strongly agree. Scores can range from 9 to 45 with higher scores representing greater acceptance. A total score of moderate acceptability for the nine items would be 27.

2 secondary outcomes

Self-efficacy Child
Time frame: Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Self-efficacy Parent
Time frame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)

Results and safety

Results posted to the registry on 8 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SLEEPSMART PROGRAM	50	48
Placebo Comparator (Usual Care)	50	40

Primary outcome: Sleep Disturbance

Time frame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion). Mean (Standard Deviation). Unit: T-score

Measure	SLEEPSMART PROGRAM n = 24	Placebo Comparator (Usual Care) n = 20
Baseline	62.1 (5.4)	62.4 (7.3)
2 months	57.7 (4.3)	58.3 (7.6)
3 months	56.4 (2.8)	58.5 (7.1)

Population analysed: At 2 and 3 months, some participants could not be reached or declined to participate.

Primary outcome: Sleep Efficiency

Time frame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion). Mean (Standard Deviation). Unit: ratio

Measure	SLEEPSMART PROGRAM n = 24	Placebo Comparator (Usual Care) n = 20
Baseline	.74 (.08)	.78 (.05)
2 months	.83 (.05)	.79 (.04)
3 months	.84 (.07)	.79 (.04)

Population analysed: At 2 months and 3 months, some participants declined to participate or could not be reached.

Primary outcome: Sleep Duration

Time frame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion). Mean (Standard Deviation). Unit: minutes

Measure	SLEEPSMART PROGRAM n = 24	Placebo Comparator (Usual Care) n = 20
Baseline	464.0 (46.7)	483.2 (25.1)
2 months	508.6 (57.4)	483.6 (28.1)
3 months	506.7 (48.1)	488.7 (33.4)

Primary outcome: Acceptability of SLEEPSMART

Time frame: 3 months at study completion. Mean (Standard Deviation). Unit: score on a scale

Measure	SLEEPSMART Child n = 12	SLEEPSMART Parent n = 12
Value	34.1 (8.2)	36.6 (6.4)

Population analysed: At 2 months and 3 months, some participants declined to participate or could not be reached.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through study completion, an average of 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SLEEPSMART PROGRAM	0 of 25 (0%)	0 of 25 (0%)	0 of 25
Placebo Comparator (Usual Care)	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Limitations and caveats (from the sponsor): 1. Single-site pilot trial which may limit the generalizability of the findings. 2. Our follow-up period was limited to one-month post-intervention, and some children and parents may have needed a longer time to see the effects of SLEEPSMART. 3. Study was conducted during the COVID-19 pandemic, and stay-at-home guidance may have altered sleep routines and patterns for children and parents.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40051205Zhai S, Palermo TM, Shenoi S, Demiris G, Howard W, Kientz J, Yuwen W, Ward TM. A shared-management web-based intervention for sleep deficiency in school-age children with juvenile idiopathic arthritis and their parents: feasibility and acceptability study. J Clin Sleep Med. 2025 Jun;21(6):1007-1021. doi: 10.5664/jcsm.11610. Epub 2025 Jun 1.
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.

Teresa M Ward, RN, PhD principal investigator

University of Washington

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing SLEEPSAMRT 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 2 inclusion and 2 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 8 Jan 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 8 Jan 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?

Sleep Disturbance (time frame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04066205, which also lists 1 linked publication.

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 8 Jan 2025.