Sleep Self-Management Intervention for Children With Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

— SLEEPSMART  

Official title:

Sleep Self-Management Intervention for Children With Juvenile Idiopathic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04066205
• Other study ID #: STUDY00005070
• Secondary ID: R21NR017471-01A1
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: May 20, 2021

Study information

• Verified date: October 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 20, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 13 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington School of Nursing	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	sleep duration	actigraphy total sleep time	change from baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Secondary	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