Implementing Behavioral Sleep Intervention in Urban Primary Care (Aim_2)

Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 2

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.

Study Overview

• Status: Completed
• Conditions: Sleep; Sleep Disturbance; Sleep Deprivation
• Intervention / Treatment: Behavioral: Sleep Well!

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Behavioral Sleep Intervention; 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.

Behavioral: Sleep Well!; The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Caregiver-child Participants Who Complete All Intervention Procedures Following Enrollment (Retention Rate)	The study team will track the number of caregiver-child dyad participants who complete all intervention procedures following enrollment.	Approximately 9 months
Number of Caregiver-child Participants Who Complete All Assessments (Pre-intervention and Post-intervention) That Were Planned (Feasibility)	The study team will track the number of proportion of participants who complete all assessments (pre-intervention and post-intervention) that were planned.	Approximately 9 months
Treatment Acceptability (Strategies)	Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention. Ratings are shown for proportion of caregivers agreeing or strongly agreeing with the statement that the strategies are acceptable.	3 months
Cultural Humility	Caregivers will complete the Multicultural Therapy Competency Inventory- Client Version (MTCI-CV), adapted to assess perceptions of the Sleep Well! therapist's/program's cultural humility (e.g. "When we discussed my child's sleep, the Sleep Well! therapist seemed to have some understanding about my/my family's culture and background" and "When we discussed my child's sleep, the Sleep Well! therapist appreciated my expertise on my own life.") Average proportion of caregivers agreeing/strongly agreeing with statements on measure is reported.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Patterns and Problems: Sleep Problem	Caregivers will complete the Brief Child Sleep Questionnaire (BCSQ) to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child sleep.	Baseline (pre-intervention) and 3 months (post-intervention).
Sleep Patterns and Problems: Sleep Onset Latency	Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep. When completing the BCSQ, caregivers are prompted to think about their child's sleep on a "typical night" over the past week (7 nights). Sleep onset latency is assessed by asking caregivers to report in minutes how long it typically takes their child to fall asleep.	3 months
Sleep Patterns and Problems: Night Awakening Duration	Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.	3 months
Sleep Patterns and Problems: Nighttime Sleep Duration	Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.	3 months
Sleep Patterns and Problems: 24-hour Sleep Duration	Caregivers will complete the BCSQ to report on child sleep habits and the severity of any caregiver-perceived sleep problems at pretreatment and posttreatment. The BCSQ is appropriate for children ages 1.5-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.	3 months

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Investigators: Principal Investigator: Ariel Williamson, PhD, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2019
• Primary Completion (Actual): July 3, 2020
• Study Completion (Actual): July 3, 2020

Study Registration Dates

• First Submitted: August 5, 2019
• First Submitted That Met QC Criteria: August 5, 2019
• First Posted (Actual): August 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: September 13, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Difficulty falling asleep; Difficulty staying asleep; Not getting enough sleep
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Dyssomnias; Parasomnias; Sleep Deprivation
• Other Study ID Numbers: 19-016482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No