Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis (SLEEPSMART)

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.

Study Overview

• Status: Completed
• Conditions: Juvenile Idiopathic Arthritis
• Intervention / Treatment: Behavioral: SLEEPSAMRT

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington School of Nursing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 13 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for Children:

• 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).

Inclusion criteria for parents:

• > 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

Exclusion Criteria for Children:

• 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.

Exclusion criteria for parents:

• diagnosed with a chronic illness that would interfere with ability to complete study procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SLEEPSMART PROGRAM; 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.

Behavioral: SLEEPSAMRT; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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;	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.	3 months at study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Teresa M Ward, RN, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 3, 2021
• Study Completion (Actual): May 20, 2021

Study Registration Dates

• First Submitted: September 5, 2018
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Sleep deficiency, self-management
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Arthritis, Juvenile
• Other Study ID Numbers: STUDY00005070; R21NR017471-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No