Implementing Behavioral Sleep Intervention in Urban Primary Care (Aim_2)

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Sleep Disturbance; Sleep Deprivation; Sleep

Treatments: Behavioral: Sleep Well!

Study type: Interventional

Funder types: Other

Identifiers

NCT04046341

19-016482

Details and patient eligibility

About

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.

Full 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 evidence base, behavioral sleep interventions are rarely tested with lower-SES children or in primary care, an accessible service delivery setting. The primary objective of this study is to determine the whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. We will also examine the direction and magnitude of change in child sleep from pre-intervention to post-intervention. This is a preliminary open trial of the Sleep Well! program with pre-intervention and post-intervention assessments.Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.

Sleep Well! is a brief, behavioral sleep intervention for toddlers and preschoolers who have a caregiver-reported sleep problem or who are not getting enough sleep. The intervention includes evidence-based behavioral sleep approaches and strategies to engage and empower families. The primary outcomes for this open trial are feasibility (number of caregivers recruited, engaged, and retained in intervention; participant intervention attendance rate) and caregiver acceptability, assessed via a questionnaire and qualitative post-intervention interview. Secondary outcomes are the direction and magnitude in any pre- to post-intervention change in child sleep.

Enrollment: 15 patients

Sex: All

Ages: 12 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Behavioral Sleep Intervention

Experimental group

Description:

Parents attend 1-3 one-hour sessions at their primary care office or via telemedicine, where they receive sleep education and work with interventionists to develop strategies to help their child at bedtime.

Treatment:

Behavioral: Sleep Well!