At a glance
ClinicalIndex Comparison Record- ✓Participant is the parent or legal guardian of the child subject
- ✓Caregiver/guardian is 18 years of age or older
- ✓Child is between 1 and 5 years old
- ✓Child has caregiver-reported sleep problem documented by Brief Child Sleep Questionnaire or meets American Academy of Sleep Medicine criteria for pediatric insomnia or insufficient sleep
- ✕Caregiver is not the parent or legal guardian of the child
- ✕Child has diagnosed neurodevelopmental disorder (e.g., autism spectrum disorder, Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or its treatment impacts sleep
- ✕Investigator believes participant may be non-compliant with study schedules or procedures
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 2
In Brief
A clinical study evaluating Sleep Well! for Sleep Disturbance and 2 related conditions. Completed, enrolled 15 participants across 1 site.
Detailed Summary
Investigators will enroll up to 20 participants from 3 Children's Hospital of Philadelphia (CHOP) primary care locations. The primary objective is to determine the whether the Sleep Well! behavioral sleep intervention is feasible to be implemented in primary care offices and acceptable to families. The direction and magnitude of change in child sleep from pre-intervention to post-intervention will also be examined.
Study Details
Timeline
Interventions
The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.