Impact of Beds for Kids Program on Child Sleep

August 11, 2021 updated by: Children's Hospital of Philadelphia

Beds for Kids Program: Impact on Child Sleep and Family Functioning in Young Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention: Bed after 7 days
Caregiver-child dyads in this condition will receive a bed, bedding, and sleep education from the Beds for Kids program 7 days after initiating daily diary/actigraph procedures.
Other: Beds for Kids program
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.
EXPERIMENTAL: Wait-list: Bed after 14 days
Caregiver-child dyads in this condition will receive a bed, bedding, and sleep education from the Beds for Kids program 14 days after initiating daily diary/actigraph procedures.
Other: Beds for Kids program
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child sleep duration
Time Frame: 14 day period
Actigraph-derived child sleep duration in hours
14 day period
Child sleep time variability
Time Frame: 14-day period
Standard deviation of actigraph-derived child sleep time
14-day period
Child sleep quality
Time Frame: 14-day period
Caregiver-rated child sleep quality
14-day period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child behavior problems (after 14-day period)
Time Frame: 14-day period
Change in caregiver-rated daily child behavior problems
14-day period
Caregiver emotional stress (after 14-day period)
Time Frame: 14-day period
Change in caregiver-reported caregiver daily caregiver stress levels.
14-day period
Child sleep duration at one-month follow-up
Time Frame: 6-7 weeks
Change in caregiver-reported child sleep duration in hours from baseline (prior to actigraph/daily diary procedures) to one month post-bed delivery.
6-7 weeks
Child behavior problems at one-month follow-up
Time Frame: 6-7 weeks
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
6-7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Ariel A Williamson, PhD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

February 3, 2020

Study Completion (ACTUAL)

February 3, 2020

Study Registration Dates

First Submitted

December 24, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (ACTUAL)

January 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 11, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-014350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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