Sleep Self-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 solely to the underlying chronic illness, and contributes to poor health outcomes. Development of an effective technology-based sleep self-management 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 self-management intervention delivered to 9-to-11 year-old children with JIA and their parents. The initial feasibility, acceptability, and efficacy of the newly developed sleep self-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. Problem-solving skills, motivation, beliefs about sleep, and sleep 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 user-centered design approach to develop and refine a technology-based sleep self-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 from our prior Web-based interventions for youth with chronic pain that includes sleep hygiene education, and a self-management focus (motivation, self-efficacy, patient activation) to develop content for the SLEEPSMART. 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, sleep quality, and feasibility/acceptability, and secondary outcomes of child and parent self-management(activation, motivation, self-efficacy), technology use, recommendations for innovative sleep monitoring

• Study Type: Interventional
• Enrollment (Actual): 44
• 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
• Genders Eligible for Study: All

Description

Inclusion Criteria for Children:

• diagnosed with JIA
• 8-13 years
• able to read/speak English
• 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
• able to read/speak English.

Exclusion Criteria for Children:

• currently receiving
• lack of daily access to the Internet or mobile device as the study will be conducted online
• developmental delay
• child is not currently participating in psychological therapy.

Exclusion criteria for parents:

• diagnosed with a chronic illness that would interfere with ability to complete study procedures
• lack of daily access to the Internet or mobile device.

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 will create a login, choose treatment goals, and interact with fields in the Web site. The modules will focus on improving sleep hygiene, relaxation, or increasing sleep duration. The intervention will last 6 to 8 weeks.

Behavioral: SLEEPSAMRT; SLEEPSMART will be designed to improve sleep by providing guidance and structure to assist JIA children and their parent in adhering to the intervention protocol. The intervention will be interactive and personalized; users will interface with three primary components:1) monitoring: daily records of sleep and symptoms; 2) skill building modules: sleep education, sleep skills training, relaxation techniques, positive coping skills, and reward systems for activity participation for reducing sleep deficiency; and 3) assignment review and personalized feedback via behavioral assignments for skill implementation and tailored feedback. Modules will take an estimated 30 minutes each week to complete and will include multimedia elements to enhance learning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep quality	Child Sleep Hygiene Scale- overall sleep hygiene score; 6-point scale; higher scores indicate better sleep hygiene.	change from baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
self-efficacy	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.	change from baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Usability of SLEEPSMART	Semi-structured interviews will be conducted to assess their overall child and parent perceptions of the web-based program, the perceived usefulness and ease of use.	3 months at study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep duration	actigraphy total sleep time	change from 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	3 months at 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): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Sleep deficiency, self-management
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue 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