N/A
N=100
Sleep Shared-Management Intervention for Children With Juvenile Idiopathic Arthritis
Juvenile Idiopathic Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT04066205 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Sleep Disturbance — 62.1; 62.4; 57.7; 58.3 T-score
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SLEEPSAMRT (Behavioral)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Disturbance |
62.1; 62.4; 57.7; 58.3; 56.4; 58.5 | — |
| PRIMARY Sleep Efficiency |
.74; .78; .83; .79; .84; .79 | — |
| PRIMARY Sleep Duration |
464.0; 483.2; 508.6; 483.6; 506.7; 488.7 | — |
| PRIMARY Acceptability of SLEEPSMART |
34.1; 36.6 | — |
| SECONDARY Self-efficacy Child |
2.5; 2.4; 2.0; 2.3; 2.0; 2.2 | — |
| SECONDARY Self-efficacy Parent |
5.8; 6.5; 7.1; 6.6; 7.5; 7.2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04066205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.