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Impact of Beds for Kids Program on Child Sleep

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ClinicalTrials.gov Identifier: NCT03392844
Recruitment Status : Completed
First Posted : January 8, 2018
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Insufficient Sleep Syndrome Inadequate Sleep Hygiene Child Behavior Problems Emotional Stress Other: Beds for Kids program Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking Description: Research team members who are responsible for the assessment of study outcomes will be blinded to group condition. Blinding of the Lead Investigator is not possible due to the need to coordinate intervention with the Beds for Kids program. Blinds of the participants is not possible due to the nature of the intervention (scheduling and provision of beds).
Primary Purpose: Treatment
Official Title: Beds for Kids Program: Impact on Child Sleep and Family Functioning in Young Children
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : February 3, 2020
Actual Study Completion Date : February 3, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Child sleep duration [ Time Frame: 14 day period ]
    Actigraph-derived child sleep duration in hours

  2. Child sleep time variability [ Time Frame: 14-day period ]
    Standard deviation of actigraph-derived child sleep time

  3. Child sleep quality [ Time Frame: 14-day period ]
    Caregiver-rated child sleep quality


Secondary Outcome Measures :
  1. Child behavior problems (after 14-day period) [ Time Frame: 14-day period ]
    Change in caregiver-rated daily child behavior problems

  2. Caregiver emotional stress (after 14-day period) [ Time Frame: 14-day period ]
    Change in caregiver-reported caregiver daily caregiver stress levels.

  3. 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.

  4. 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


Eligibility Criteria
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Ages Eligible for Study:   24 Months to 71 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392844


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Ariel A Williamson, PhD Children's Hospital of Philadelphia
More Information
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Publications:
Achenbach TM. The Achenbach System of Empirically Based Assessment (ASEBA): Development, Findings, Theory, and Applications. 2009; Burlington, VT: University of Vermont Research Center for Children, Youth, and Families.
Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1977;1:385-401.

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03392844    
Other Study ID Numbers: 17-014350
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: August 18, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Deprivation
Problem Behavior
Behavioral Symptoms
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders