Clinical trial NCT04536766: Impact of Bed Provision and Sleep Education
Official title: Impact of Bed Provision and Enhanced Sleep Health Education on Sleep in Socio-economically Disadvantaged Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Sleep Deprivation
Sleep
Insomnia
Lead sponsor: Saint Joseph's University, Philadelphia
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 90
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 100 Caregiver-child dyads (children ages 8-12 years) will be recruited from the Beds for Kids program.
Primary purpose: TREATMENT

Brief summary: Investigators will recruit up to 100 families (children aged 8-12 years and their primary caregivers) from the Philadelphia-area Beds for Kids charity program, which provides beds, bedding, and sleep education to lower-socioeconomic status (SES) children. The primary objective of this randomized controlled trial is to determine whether bed provision combined with provider-delivered sleep health education can improve sleep in children participating in the Beds for Kids program.

Detailed description: Insufficient and poor-quality sleep impacts more than half of school-aged children, and is associated with significant impairments in child neurocognitive, academic, behavioral, and physical health functioning. Lower socioeconomic status (SES) children are at increased risk for poor sleep. Compared to their higher-SES peers, lower-SES youth tend to obtain less sleep overall and experience worse sleep quality. Many children of lower-SES also may live in noisy or high-violence neighborhoods and in overcrowded homes that lack a child bed or other designated child sleep space. These environmental factors may perpetuate SES-related health disparities in child sleep duration, quality, and poor sleep health behaviors (i.e., bedroom electronics). Although there is a robust evidence-base for treating childhood sleep problems, there is a paucity of sleep intervention research focused on lower-SES children.

Beds for Kids is a Philadelphia-area program that is part of the larger volunteer organization, One House at a Time, that provides lower-SES children with beds, bedding, and a sleep education brochure. To qualify for program participation, youth must be: (1) between the ages of 2 and 20 years, (2) living without an individual bed (e.g., sleeping on the floor, on a sofa, or crowded into one bed with family members), and (3) living in a household whose income is at or below 100 percent of the United States poverty threshold. The program accepts referrals from area social service agencies in the greater Philadelphia area.

Eligibility criteria: Inclusion Criteria:

* Caregiver participant is the parent or legal guardian of the child participant.
* Caregiver/legal guardian is 18 years of age.
* Child between 8 and 12 years of age.
* English-speaking

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Treatment acceptability: Treatment Evaluation Inventory-Short Form
timeFrame: 2 months
measure: Sleep health-related behaviors
timeFrame: 2 months
measure: Sleep outcomes
timeFrame: 2 months
Secondary outcomes:
measure: Family engagement
timeFrame: 12 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Saint Joseph's University
state: Pennsylvania
Study officials:
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