Impact of Bed Provision and Sleep Education

Saint Joseph's University, Philadelphia

Status: Completed

Conditions: Insomnia; Sleep Disturbance; Sleep Deprivation; Sleep

Treatments: Behavioral: Enhanced Sleep Health Education; Behavioral: Beds for Kids Standard Program

Study type: Interventional

Funder types: Other

Identifiers

NCT04536766

2020-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Enhanced Sleep Health Education

Experimental group

Description:

50 families will be randomly assigned to receive sleep health education delivered in two telephone sessions by Beds for Kids staff members, in addition to receiving the standard Beds for Kids program (bed, bedding, written sleep education materials). The first session will occur approximately 2-3 days before bed delivery. The second 15-20-minute session will occur approximately one week following bed delivery. Sleep health education training and supervision of Beds for Kids staff members will be provided by board-certified Behavioral Sleep Medicine providers. Sleep health information will be manualized and will consist of evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs.

Treatment:

Behavioral: Enhanced Sleep Health Education

Beds for Kids Standard Program

Active Comparator group

Description:

50 families will be randomly assigned to the standard Beds for Kids program, which includes a bed, bedding, and written sleep education materials.

Treatment:

Behavioral: Beds for Kids Standard Program