Behavioral Sleep Intervention in Urban Primary Care: Aim 3

Completed · Not applicable

Conditions studied: Sleep Disturbance, Sleep Deprivation, Sleep

In brief

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 determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude in any change in child sleep and child behavior.

Key facts

Study ID

NCT04473222

Run by

Children's Hospital of Philadelphia

People needed

103

Starts

2020-10-16

Expected to finish

2023-07-31

Last updated by the study team

2026-03-16

Who can join

Age: 1 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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