Clinical trial NCT04066205: Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis
Official title: Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Juvenile Idiopathic Arthritis
Keywords: Sleep deficiency, self-management
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2019-08-26
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This pilot RCT, comparing usual care to SLEEPSMART intervention with 60 JIA children and their parents
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep Disturbance
timeFrame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
measure: Sleep Efficiency
timeFrame: Baseline (start of the study); 2 months (immediately after the intervention), and 3 months (study completion)
measure: Sleep Duration
timeFrame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
measure: Acceptability of SLEEPSMART
timeFrame: 3 months at study completion
Secondary outcomes:
measure: Self-efficacy Child
timeFrame: Baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
measure: Self-efficacy Parent
timeFrame: baseline (start of the study); 2 months (immediately after the intervention) and 3 months (study completion)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Nursing
state: Washington
Study officials:
affiliation: University of Washington
name: Teresa M Ward, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: