Behavioral Sleep Intervention in Urban Primary Care: Aim 3

Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 3

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.

Study Overview

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

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 whether the Sleep Well! behavioral sleep intervention is feasible and acceptable to families. The investigators will also examine the direction and magnitude of change in child sleep and behavior from pre-intervention to post-intervention. This is a randomized controlled trial of the Sleep Well! program with pre-intervention, post-intervention, and follow-up 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 behavioral 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 change in child sleep. Tertiary outcomes are the direction and magnitude in change in child behavior. Assessments occur at pre-intervention, post-intervention, and follow-up.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ariel Williamson, PhD; Phone Number: 267-425-1301; Email: WILLIAMSOA@chop.edu
• Study Contact Backup: Name: Olivia Cicalese, MS; Phone Number: 215-590-2294; Email: CICALESEO@chop.edu

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

Description

Inclusion Criteria:

1. Parental/guardian permission (informed consent)
2. Caregiver participant is the parent or legal guardian of the child subject
3. Caregiver/legal guardian is greater than or equal to 18 years of age.
4. Child between the ages of 1 and 5 years.
5. 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.
6. English-speaking.

Exclusion Criteria:

1. Caregiver is not parent or legal guardian of child participant.
2. 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.
3. 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: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sleep Well! Intervention; Participants in this condition will begin the Sleep Well! intervention after initiating baseline, daily diary, and actigraph procedures. Sleep Well! will be provided over approximately 6-8 weeks and will include 3 sessions. Intervention sessions will typically last about an hour, but session length may vary.	Behavioral: Sleep Well!; Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally comprised of healthy sleep advice and tested in the context of a sleep health education campaign for impoverished children. Based on preliminary research regarding the need for sleep intervention in primary care, Investigators have expanded the intervention to more comprehensively address 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 who are living in disadvantaged contexts. Intervention components are based on effective pediatric behavioral sleep treatments.
Other: Enhanced Usual Care; The enhanced usual care condition will occur between 6 and 8 weeks. At randomization to this condition, participants will be provided with an evidence-based sleep guidelines for young children from the CHOP Parent Family Education manual. Participants in this condition will also be able to consult with their primary care physician for management of child sleep. Consistent with usual care in the CHOP system, the primary care physician may manage the sleep concern or choose to make a referral to the CHOP sleep center or to other behavioral health services internal or external to the CHOP system. Of note, the CHOP Parent Family Education handouts provide contact information for the CHOP Sleep Center and direct readers to follow-up with their primary care provider for further guidance.	Behavioral: Sleep education; Sleep education for caregivers of toddlers and preschoolers is provided via a Parent Family Education handout available to families and clinicians in the CHOP primary care network. The handout contains evidence-based advice about healthy sleep in early childhood.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention Rate	The study team will track the number of caregiver-child dyad participants who complete all study procedures following enrollment.	24 months (study duration)
Family Engagement and Adherence	Study interventionists will keep records of family intervention attendance, including the number of sessions that the family attended, rescheduled, and no-showed, and the number of phone calls that families completed. Study interventionists will also keep records of families' usage of intervention strategies, based on feedback from families in-session.	24 months (study duration)
Treatment Acceptability	Caregivers will complete the Treatment Evaluation Inventory-Short Form, a widely used measures of treatment acceptability that has been adapted for the purposes of the Sleep Well! intervention, and the Multicultural Therapy Competency Inventory- Client Version to assess patient's perceptions of the Sleep Well! therapist's cultural sensitivity during discussions about safe sleep. Caregivers will also complete an audio-recorded, open-ended qualitative interview (15-20 minutes) with questions related to aspects of the intervention that were helpful/unhelpful, how the intervention could be improved, and the acceptability of the measurement process.	3 months (post-intervention)
Assessment Process	The study team will keep records of the number of planned assessments that are completed.	24 months (study duration)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child Sleep Problems	Caregivers will complete the BCSQ to report on the severity of any caregiver-perceived sleep problems at pre-intervention, post-intervention, and follow-up.	Baseline, post-intervention assessment, and 1 month follow-up
Child Sleep Patterns	Caregivers will complete the BCSQ to report on child sleep habits (sleep time, total sleep duration, night wakings, aspects of the sleep environment, etc.) at pre-intervention, post-intervention, and follow-up. The BCSQ is appropriate for children ages 1-5 years and has shown good reliability and moderate correspondence with actigraphic recordings of child-sleep.	Baseline, post-intervention assessment, and 1 month follow-up
Child Sleep Patterns	Caregivers will have their child wear an actigraph to obtain objective estimates of sleep onset, sleep offset, and sleep duration at pre-intervention, post-intervention, and follow-up.	7 days at baseline, post-intervention assessment, and 1 month follow-up
Child Behavior Problems	Caregivers will complete the Child Behavioral Checklist for ages 1.5-5 years to report on child internalizing and externalizing concerns at pre-intervention, post-intervention, and follow-up. The CBCL has shown strong reliability and validity in large validation studies and is a widely used measure of child behavior.	Baseline, post-intervention assessment, and 1 month follow-up

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Ariel Williamson, PhD, Children's Hospital of Philadelphia

Publications and helpful links

General Publications

• Mindell JA, Williamson AA. Benefits of a bedtime routine in young children: Sleep, development, and beyond. Sleep Med Rev. 2018 Aug;40:93-108. doi: 10.1016/j.smrv.2017.10.007. Epub 2017 Nov 6.
• Meltzer LJ, Mindell JA. Systematic review and meta-analysis of behavioral interventions for pediatric insomnia. J Pediatr Psychol. 2014 Sep;39(8):932-48. doi: 10.1093/jpepsy/jsu041. Epub 2014 Jun 19. Erratum In: J Pediatr Psychol. 2015 Mar;40(2):262-5.
• Quach J, Gold L, Arnup S, Sia KL, Wake M, Hiscock H. Sleep well--be well study: improving school transition by improving child sleep: a translational randomised trial. BMJ Open. 2013 Oct 28;3(10):e004009. doi: 10.1136/bmjopen-2013-004009.
• Allen SL, Howlett MD, Coulombe JA, Corkum PV. ABCs of SLEEPING: A review of the evidence behind pediatric sleep practice recommendations. Sleep Med Rev. 2016 Oct;29:1-14. doi: 10.1016/j.smrv.2015.08.006. Epub 2015 Sep 1.
• Williamson AA, Milaniak I, Watson B, Cicalese O, Fiks AG, Power TJ, Barg FK, Beidas RS, Mindell JA, Rendle KA. Early Childhood Sleep Intervention in Urban Primary Care: Caregiver and Clinician Perspectives. J Pediatr Psychol. 2020 Sep 1;45(8):933-945. doi: 10.1093/jpepsy/jsaa024.
• Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.

Helpful Links

• Created by the Pediatric Sleep Council, babysleep.com provides comprehensive and expert-based information on baby and toddler sleep that is freely available to the public.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2020
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: July 13, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Neurologic Manifestations; Dyssomnias; Parasomnias; Sleep Deprivation
• Other Study ID Numbers: 20-017788; 5K23HD094905-02 (U.S. NIH Grant/Contract)

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