Implementing Behavioral Sleep Intervention in Urban Primary Care

NCT04046341 | Completed Results DMC

• 1 other identifier: 19-016482
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disturbance; Sleep Deprivation; Sleep

Keywords

Difficulty falling asleep; Difficulty staying asleep; Not getting enough sleep

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Sleep Patterns and Problems: Sleep Problem

  Baseline (pre-intervention) and 3 months (post-intervention).

• Sleep Patterns and Problems: Sleep Onset Latency

  3 months

• Sleep Patterns and Problems: Night Awakening Duration

  3 months

• Sleep Patterns and Problems: Nighttime Sleep Duration

  3 months

• Sleep Patterns and Problems: 24-hour Sleep Duration

  3 months

Study Arms (1)

Behavioral Sleep Intervention

EXPERIMENTAL

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!

Interventions

Sleep Well! BEHAVIORAL

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.

Behavioral Sleep Intervention

Eligibility Criteria

• Age: 12 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 34910624 DERIVED

MeSH Terms

Conditions

Parasomnias; Sleep Deprivation

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Dyssomnias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Marsha Wallace
• Organization: Children's Hospital of Philadelphia

wallacem@chop.edu

2155900119

Study Officials

• Ariel Williamson, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 6, 2019
• Study Start: October 14, 2019
• Primary Completion: July 3, 2020
• Study Completion: July 3, 2020
• Last Updated: October 8, 2021
• Results First Posted: October 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)