Clinical trial NCT04046341: Implementing Behavioral Sleep Intervention in Urban Primary Care
Official title: Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Sleep Deprivation
Sleep
Keywords: Difficulty falling asleep
Difficulty staying asleep
Not getting enough sleep
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate)
timeFrame: Approximately 9 months
measure: Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility)
timeFrame: Approximately 9 months
measure: Treatment Acceptability (Strategies)
timeFrame: 3 months
measure: Cultural Humility
timeFrame: 3 months
Secondary outcomes:
measure: Sleep Patterns and Problems: Sleep Problem
timeFrame: Baseline (pre-intervention) and 3 months (post-intervention).
measure: Sleep Patterns and Problems: Sleep Onset Latency
timeFrame: 3 months
measure: Sleep Patterns and Problems: Night Awakening Duration
timeFrame: 3 months
measure: Sleep Patterns and Problems: Nighttime Sleep Duration
timeFrame: 3 months
measure: Sleep Patterns and Problems: 24-hour Sleep Duration
timeFrame: 3 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Ariel Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Williamson AA, Okoroji C, Cicalese O, Evans BC, Ayala A, Harvey B, Honore R, Kratchman A, Beidas RS, Fiks AG, Power TJ, Mindell JA. Sleep Well! An adapted behavioral sleep intervention implemented in urban primary care. J Clin Sleep Med. 2022 Apr 1;18(4):1153-1166. doi: 10.5664/jcsm.9822.