ClinicalTrials.gg
CompletedNCT03392844Updated Jul 3, 2024

Impact of Beds for Kids Program on Child Sleep

An interventional study of Beds for Kids program in Insufficient Sleep Syndrome, Inadequate Sleep Hygiene and Child Behavior Problems, sponsored by Children's Hospital of Philadelphia. Completed at 1 site in United States. Open to participants aged 24 Months to 71 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.

Sponsored by Children's Hospital of Philadelphia · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
24 Months to 71 Months
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 146 studies in Sleep Deprivation with a site in United States — 30 open to participants now, 35 under way, none of them phase 3. Sleep Deprivation · United States.

Enrollment
74th of 127
42 · median 56
Started
2017
with 8 others
No phase
104 of 146
25 open now
Registered
66th of 146
by date
Lead sponsor
5 of 146
Children's Hospital of Philadelphia

Among the 146 studies in Sleep Deprivation with a site in United States, this one is the 74th largest by enrollment of the 127 interventional ones that give a count, is one of 9 that started in 2017, is one of 104 with no phase, and was the 66th registered.

Sleep Deprivation

314 studies on the registry are indexed under Sleep Deprivation; 59 are open to participants now.

Browse Sleep Deprivation studies →

Open to participants now

30 of the 146 studies in Sleep Deprivation with a site in United States are open now. Recruiting first, the newest first:

25 more — sign in →

All 30 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 43 Sleep Deprivation studies recruiting now, 11 (26%) set no upper age limit and 28 (65%) stop at 75 or younger; 5 take children under 18; 29 take healthy volunteers.

This study: 24 Months to 71 Months · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 146 studies in Sleep Deprivation with a site in United States, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Insufficient Sleep Syndrome
  • Inadequate Sleep Hygiene
  • Child Behavior Problems
  • Emotional Stress
04

Who can participate

Ages eligible
24 Months to 71 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherBeds 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.

06

What researchers measure

Primary outcomes

  1. Child sleep duration

    Actigraph-derived child sleep duration in hours

    Time frame: 14 day period

  2. Child sleep time variability

    Standard deviation of actigraph-derived child sleep time

    Time frame: 14-day period

  3. Child sleep quality

    Caregiver-rated child sleep quality

    Time frame: 14-day period

Secondary outcomes

  1. Child behavior problems (after 14-day period)

    Change in caregiver-rated daily child behavior problems

    Time frame: 14-day period

  2. Caregiver emotional stress (after 14-day period)

    Change in caregiver-reported caregiver daily caregiver stress levels.

    Time frame: 14-day period

  3. 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

  4. 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

07

Study locations

1 site
  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
08

References and documents

Publications

  • 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. PubMed 27655459 ↗
  • 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. PubMed 25701537 ↗
  • 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. PubMed 19745760 ↗
  • 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. PubMed 15978515 ↗
  • 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. PubMed 26994853 ↗
  • 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. PubMed 17371111 ↗
  • 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. PubMed 27189691 ↗
  • 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. PubMed 27306269 ↗
  • 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. PubMed 24235895 ↗
  • 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.
  • 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. PubMed 21237680 ↗
  • 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. PubMed 37086055 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Feb 2020, 26 months.

Of 141 non-industry interventional studies with no phase under Sleep Deprivation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 44. This study's 26 months is above that.

Counting every sponsor, half of 150 studies reached it within 17 months; a quarter within 7 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2017
First posted
Jan 8, 2018
StartActual
Dec 1, 2017
Primary completionActual
Feb 3, 2020
CompletionActual
Feb 3, 2020
Last update
Jul 3, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 3, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03392844
Responsible party
Sponsor
First posted
Jan 8, 2018
Start date
Dec 1, 2017
Primary completion
Feb 3, 2020
Completion
Feb 3, 2020
Last update
Jul 3, 2024

Study contacts

Ariel A Williamson, PhD
principal investigator · Children's Hospital of Philadelphia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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