Clinical trial NCT03392844: Impact of Beds for Kids Program on Child Sleep
Official title: Beds for Kids Program: Impact on Child Sleep and Family Functioning in Young Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insufficient Sleep Syndrome
Inadequate Sleep Hygiene
Child Behavior Problems
Emotional Stress
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 42
Sex: ALL
Minimum age (years): 24
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Caregiver-child dyads will be assigned to the intervention group, in which they receive a bed through the Beds for Kids program after a 7-day period, or to the waitlist control group, in which they receive a bed after a 14-day period.
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the impact of provision of a child bed through the Beds for Kids program on objectively measured child sleep, and on daily child behavioral functioning and caregiver functioning over a 14-day period for preschool-aged children.

Detailed description: Many lower-socioeconomic status (SES) children live in crowded homes and lack their own bed, which can contribute to insufficient and poor quality sleep and related poor child and family functioning. The Beds for Kids program provides beds and bedding to disadvantaged children in Philadelphia, and has been found to positively impact parent-reported child sleep in a previous pilot study. However, there is a need to determine the impact of the Beds for Kids program on objectively assessed child sleep, as well as on daily child behavior and caregiver functioning (mood and sleep). The primary objective of this study is to evaluate the impact of provision of a child bed through the Beds for Kids program on objectively measured child sleep, and on daily child behavioral functioning and caregiver functioning over a 14-day period for preschool-aged children. This is a randomized controlled trial (RCT). Caregiver-child dyads will be assigned to the intervention group, in which they receive a bed through the Beds for Kids program after a 7-day period, or to the waitlist control group, in which they receive a bed after a 14-day period. The primary study outcome is the difference between study conditions in actigraph-derived and caregiver-reported child sleep (bedtime, bedtime variability, sleep quality, night wakings, total sleep duration) for days 7 to 14 (bed vs control), as well as compared to baseline. Thus, this is a mixed between (bed vs waitlist) and within (days 1-7 vs days 8-14) group design.

Eligibility criteria: Inclusion Criteria:

* Males or females ages 2 to 5 years (24-71 months) and their male or female caregiver reporter (legal guardian)
* Eligible for the Beds for Kids program: (a) living without individual bedding (sleeping on the floor, on a sofa, or crowded into one bed with family members); (b) living in a household whose income is at or below 100 percent of the Federal Poverty Guideline.
* Parent/guardian is English-speaking.
* Caregiver is legal guardian and can complete informed consent.

Exclusion Criteria:

* Presence of a chronic medical (e.g., cancer, sickle cell disease) or neurodevelopmental (e.g., autism, Trisomy 21) that would impact sleep, including a pre-existing sleep disorder diagnosis (e.g., obstructive sleep apnea) in child.
* Child or caregiver use of prescription (e.g., clonidine) or over-the-counter medication (e.g., Benadryl; melatonin) that could impact the child's sleep or caregiver report of child's sleep.
* Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.

Primary outcomes:
measure: Child sleep duration
timeFrame: 14 day period
measure: Child sleep time variability
timeFrame: 14-day period
measure: Child sleep quality
timeFrame: 14-day period
Secondary outcomes:
measure: Child behavior problems (after 14-day period)
timeFrame: 14-day period
measure: Caregiver emotional stress (after 14-day period)
timeFrame: 14-day period
measure: Child sleep duration at one-month follow-up
timeFrame: 6-7 weeks
measure: Child behavior problems at one-month follow-up
timeFrame: 6-7 weeks
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 A Williamson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Williamson AA, Min J, Fay K, Cicalese O, Meltzer LJ, Mindell JA. A multimethod evaluation of bed provision and sleep education for young children and their families living in poverty. J Clin Sleep Med. 2023 Sep 1;19(9):1583-1594. doi: 10.5664/jcsm.10614.