Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis

NCT04066205 | Completed Results DMC

• 2 other identifiers: STUDY00005070R21NR017471-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Juvenile Idiopathic Arthritis

Keywords

Sleep deficiency, self-management

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Self-efficacy Child

  Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)

• Self-efficacy Parent

  baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)

Study Arms (1)

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.

Behavioral: SLEEPSAMRT

Interventions

SLEEPSAMRT 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.

SLEEPSMART PROGRAM

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• 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.

  PMID: 40051205 DERIVED

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Teresa Ward, Professor, Department of Pediatrics
• Organization: University of Washington

teresa.ward@seattlechildrens.org

206-884-1439

Study Officials

• Teresa M Ward, RN, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, School of Nursing: Psychosocial and Community Health

Model Details: This pilot RCT, comparing usual care to SLEEPSMART intervention with 60 JIA children and their parents

Study Record Dates

• First Submitted: September 5, 2018
• First Posted: August 26, 2019
• Study Start: November 1, 2019
• Primary Completion: March 3, 2021
• Study Completion: May 20, 2021
• Last Updated: January 8, 2025
• Results First Posted: January 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)