Clinical trial NCT04473222: Behavioral Sleep Intervention in Urban Primary Care: Aim 3
Official title: Implementing Evidence-based Behavioral Sleep Intervention in Urban Primary Care: Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Sleep Deprivation
Sleep
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2020-07-16
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Caregiver-child dyads (child ages 1-5 years with a sleep problem) will be recruited from CHOP urban primary care sites and randomly assigned either to the intervention or to an enhanced usual care condition (sleep education handout).
Primary purpose: TREATMENT

Brief 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.

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 and follow-up. 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 pilot 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention Rate (Intervention Feasibility)
timeFrame: Study duration (up to 24 weeks)
measure: Family Engagement (Sessions)
timeFrame: Study duration (up to 24 weeks)
measure: Family Engagement (Telephone Calls)
timeFrame: Study duration (up to 24 weeks)
measure: Treatment Acceptability
timeFrame: Time 2 (an average of 9 weeks post-baseline)
measure: Treatment Acceptability: Cultural Humility
timeFrame: Time 2 (an average of 9 weeks post-baseline)
measure: Assessment Process (Study Feasibility)
timeFrame: Study duration (up to 24 weeks)
Secondary outcomes:
measure: Severity of Child Sleep Problems
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Sleep Problems: Bedtime Difficulties
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Sleep Patterns: Sleep Onset Latency
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Sleep Patterns: Number of Wakings Per Night
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Sleep Patterns: Duration of Wakings Per Night
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Sleep Patterns: Nighttime Sleep Duration
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Sleep Patterns: Total 24-hour Sleep Duration
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Sleep Patterns: Actigraphy Derived Nighttime Sleep Duration
timeFrame: 7 days at Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Behavior Problems: Externalizing Problems
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
measure: Child Behavior Problems: Internalizing Problems
timeFrame: Baseline (pre-intervention), Time 2 (an average of 9 weeks post-baseline), and Time 3 (an average of 15 weeks post-baseline)
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: 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.
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.
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.
citation: 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.
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.
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.