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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Bed after 7 days | Experimental | 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. |
|
| Wait-list: Bed after 14 days | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beds for Kids program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Child sleep duration | Actigraph-derived child sleep duration in hours | 14 day period |
| Child sleep time variability | Standard deviation of actigraph-derived child sleep time | 14-day period |
| Child sleep quality | Caregiver-rated child sleep quality | 14-day period |
| Measure | Description | Time Frame |
|---|---|---|
| Child behavior problems (after 14-day period) | Change in caregiver-rated daily child behavior problems | 14-day period |
| Caregiver emotional stress (after 14-day period) | Change in caregiver-reported caregiver daily caregiver stress levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ariel A Williamson, PhD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27655459 | Background | 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. | |
| 25701537 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 21, 2019 | Jun 25, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D001513 | Beds |
| ID | Term |
|---|---|
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
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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.
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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).
|
| 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. | 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 | 6-7 weeks |
| 19745760 | Background | 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. |
| 15978515 | Background | 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. |
| 26994853 | Background | 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. |
| 17371111 | Background | 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. |
| 27189691 | Background | 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. |
| 27306269 | Background | 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. |
| 24235895 | Background | 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. |
| Background | 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. |
| Background | Radloff LS. The CES-D scale: a self-report depression scale for research in the general population. Appl Psychol Meas 1977;1:385-401. |
| 21237680 | Background | 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. |
| 37086055 | Result | 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. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |