Behavioral Sleep Intervention in Urban Primary Care: Aim 3

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04473222
• Other study ID #: 20-017788
• Secondary ID: 5K23HD094905-02
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: July 31, 2023

Study information

• Verified date: August 2023
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias
• Sleep
• Sleep Deprivation
• Sleep Disturbance

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	Assessment Process	The study team will keep records of the number of planned assessments that are completed.	24 months (study duration)
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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