N/A
Completed N=16
Sleep Innovations for Preschoolers With Arthritis (SIPA): Developing and Pilot Testing of a Self-Management Intervention
Source: ClinicalTrials.gov NCT04354337 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcomePrimary: Feasibility as Assessed by Adherence — 12 Participants
Summary
Behavioral sleep problems such as sleep onset delays and frequent night wakings are common among young children (2-5 years). Children with a chronic health condition such as juvenile idiopathic arthritis (JIA) are even more prone to sleep problems, which are also associated with disease-related symptoms such as pain and fatigue. Early childhood is a critical period for establishing healthy sleep habits and self-regulation skills and is therefore an opportune time to identify and address unhealthy sleep habits. The Sleep Innovation for Preschoolers with Arthritis (SIPA) project will develop and pilot test a technology-based sleep intervention for parents of young children with JIA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Assessed by Adherence |
12 | — |
| PRIMARY Children's Sleep Habits Questionnaire |
48.36; 40.82; 38.90 | — |
Eligibility Criteria
Inclusion Criteria for children:
- diagnosed with JIA
- 2-to-5 years
- parent report of sleep problems or sleep less than 9 hours/day
Inclusion Criteria for parents:
- >18 years
- able to read/speak English
Exclusion Criteria for children:
- diagnosed primary sleep disorder (e.g., obstructive sleep apnea)
- positive screen on the Pediatric Sleep Questionnaire (> 0.33) for sleep-disordered breathing (investigators will suggest follow up with the child's primary care provider because treatment of this condition is beyond the scope this intervention)
- developmental delay
- co-morbid condition (asthma, diabetes)
Exclusion Criteria for parents:
- nightshift work that would interfere with performing bedtime activities with children
- diagnosed with a chronic illness that would interfere with completing study procedures
- lack of daily access to the Internet or mobile device
Data sourced from ClinicalTrials.gov (NCT04354337). 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. Informational only — not medical advice.