Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis

NCT ID: NCT04066205

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2021-05-20

Brief Summary

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

SLEEPSAMRT

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Teresa Ward

Professor, School of Nursing: Psychosocial and Community Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Teresa M Ward, RN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington School of Nursing

Seattle, Washington, United States

Countries

United States

References

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 1;21(6):1007-1021. doi: 10.5664/jcsm.11610.

Reference Type: DERIVED

PMID: 40051205 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21NR017471-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00005070

Identifier Type: -

Identifier Source: org_study_id