Status:
COMPLETED
Behavioral Sleep Intervention in Urban Primary Care: Aim 3
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Sleep Disturbance
Sleep Deprivation
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
Investigators will enroll up to 120 parent-child dyads from Children's Hospital of Philadelphia (CHOP) urban primary care clinics. The primary objective of this randomized clinical trial is to determi...
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
- Parental/guardian permission (informed consent)
- Caregiver participant is the parent or legal guardian of the child subject
- Caregiver/legal guardian is greater than or equal to 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 child neurodevelopmental (e.g., autism spectrum disorder; Trisomy 21) or chronic medical (e.g., sickle cell disease, cancer) concern 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 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2023
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04473222
Start Date
October 16 2020
End Date
July 31 2023
Last Update
February 5 2025
Active Locations (1)
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1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104