- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03392844
Impact of Beds for Kids Program on Child Sleep
July 1, 2024 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
-
-
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
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 Assignment
- 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.
|
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.
|
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.
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
- McLaughlin Crabtree V, Beal Korhonen J, Montgomery-Downs HE, Faye Jones V, O'Brien LM, Gozal D. Cultural influences on the bedtime behaviors of young children. Sleep Med. 2005 Jul;6(4):319-24. doi: 10.1016/j.sleep.2005.02.001. Epub 2005 Apr 1.
- Meltzer LJ, Mindell JA. Relationship between child sleep disturbances and maternal sleep, mood, and parenting stress: a pilot study. J Fam Psychol. 2007 Mar;21(1):67-73. doi: 10.1037/0893-3200.21.1.67.
- Sadeh A. The role and validity of actigraphy in sleep medicine: an update. Sleep Med Rev. 2011 Aug;15(4):259-67. doi: 10.1016/j.smrv.2010.10.001. Epub 2011 Jan 14.
- Mindell JA, Sedmak R, Boyle JT, Butler R, Williamson AA. Sleep Well!: A Pilot Study of an Education Campaign to Improve Sleep of Socioeconomically Disadvantaged Children. J Clin Sleep Med. 2016 Dec 15;12(12):1593-1599. doi: 10.5664/jcsm.6338.
- Bagley EJ, Kelly RJ, Buckhalt JA, El-Sheikh M. What keeps low-SES children from sleeping well: the role of presleep worries and sleep environment. Sleep Med. 2015 Apr;16(4):496-502. doi: 10.1016/j.sleep.2014.10.008. Epub 2014 Dec 16.
- Hale L, Berger LM, LeBourgeois MK, Brooks-Gunn J. Social and demographic predictors of preschoolers' bedtime routines. J Dev Behav Pediatr. 2009 Oct;30(5):394-402. doi: 10.1097/DBP.0b013e3181ba0e64.
- de Jong DM, Cremone A, Kurdziel LB, Desrochers P, LeBourgeois MK, Sayer A, Ertel K, Spencer RM. Maternal Depressive Symptoms and Household Income in Relation to Sleep in Early Childhood. J Pediatr Psychol. 2016 Oct;41(9):961-70. doi: 10.1093/jpepsy/jsw006. Epub 2016 Mar 19.
- Van Dyk TR, Thompson RW, Nelson TD. Daily Bidirectional Relationships Between Sleep and Mental Health Symptoms in Youth With Emotional and Behavioral Problems. J Pediatr Psychol. 2016 Oct;41(9):983-92. doi: 10.1093/jpepsy/jsw040. Epub 2016 May 16.
- Pena MM, Rifas-Shiman SL, Gillman MW, Redline S, Taveras EM. Racial/Ethnic and Socio-Contextual Correlates of Chronic Sleep Curtailment in Childhood. Sleep. 2016 Sep 1;39(9):1653-61. doi: 10.5665/sleep.6086.
- Kushnir J, Sadeh A. Correspondence between reported and actigraphic sleep measures in preschool children: the role of a clinical context. J Clin Sleep Med. 2013 Nov 15;9(11):1147-51. doi: 10.5664/jcsm.3154.
- 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.
- Williamson AA, Min J, Fay K, Cicalese O, Meltzer LJ, Mindell JA. A multimethod evaluation of bed provision and sleep education for young children and their families living in poverty. J Clin Sleep Med. 2023 Sep 1;19(9):1583-1594. doi: 10.5664/jcsm.10614.
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)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 1, 2024
Last Verified
July 1, 2024
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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