Status:
COMPLETED
Implementing Behavioral Sleep Intervention in Urban Primary Care
Lead Sponsor:
Children's Hospital of Philadelphia
Conditions:
Sleep Disturbance
Sleep Deprivation
Eligibility:
All Genders
12-5 years
Phase:
NA
Brief 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 s...
Detailed Description
Behavioral sleep problems such as insomnia and insufficient sleep are common in toddlers and preschoolers and disproportionately impact lower socioeconomic status (SES) children. Despite a robust evid...
Eligibility Criteria
Inclusion
- Caregiver participant is the parent or legal guardian of the child subject.
- Caregiver/legal guardian 18 years of age.
- Child between the ages of 1 and 5 years.
- Presence of caregiver-reported child sleep problem determined by a Brief Child Sleep Questionnaire item, included in an eligibility screening questionnaire or child meets American Academy of Sleep Medicine diagnostic criteria for either pediatric insomnia or insufficient sleep, assessed through an eligibility screening questionnaire.
- English-speaking.
Exclusion
- Caregiver is not parent or legal guardian of child participant.
- Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep.
- Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
Key Trial Info
Start Date :
October 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04046341
Start Date
October 14 2019
End Date
July 3 2020
Last Update
October 8 2021
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104