Impact of Beds for Kids Program on Child Sleep

Children's Hospital of Philadelphia42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Insufficient Sleep Syndrome Inadequate Sleep Hygiene Child Behavior Problems Emotional Stress

Interventions

Beds for Kids programOTHER

The Beds for Kids program, which is part of the non-profit organization One House at a Time, gives every child in the program a new twin-size bed mattress, metal bed frame, and a "bedtime bag," which contains a sheet set, blanket, pillow, several books, stuffed animal, and toothbrush. Children also receive educational messages about healthy sleep habits via a magnet and "color-your-own" bookmark. All of the items are sorted, packaged, and delivered directly to program recipients in their homes.

Eligibility

Sex: ALLMin age: 24 MonthsMax age: 71 MonthsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Child sleep duration

Actigraph-derived child sleep duration in hours

Time frame: 14 day period

Child sleep time variability

Standard deviation of actigraph-derived child sleep time

Time frame: 14-day period

Child sleep quality

Caregiver-rated child sleep quality

Time frame: 14-day period

Secondary Outcomes

Child behavior problems (after 14-day period)

Change in caregiver-rated daily child behavior problems

Time frame: 14-day period

Caregiver emotional stress (after 14-day period)

Change in caregiver-reported caregiver daily caregiver stress levels.

Time frame: 14-day period

Child sleep duration at one-month follow-up

Change in caregiver-reported child sleep duration in hours from baseline (prior to actigraph/daily diary procedures) to one month post-bed delivery.

Time frame: 6-7 weeks

Child behavior problems at one-month follow-up

Change in caregiver-reported child behavior problems from baseline (prior to actigraph/daily diary procedures) to one month post-bed delivery: Child Behavior Checklist measure

Time frame: 6-7 weeks

Data from ClinicalTrials.gov

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