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Impact of Beds for Kids Program on Child Sleep

Primary Purpose

Insufficient Sleep Syndrome, Inadequate Sleep Hygiene, Child Behavior Problems

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Beds for Kids program
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insufficient Sleep Syndrome

Eligibility Criteria

24 Months - 71 Months (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention: Bed after 7 days

Wait-list: Bed after 14 days

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Child sleep duration
Actigraph-derived child sleep duration in hours
Child sleep time variability
Standard deviation of actigraph-derived child sleep time
Child sleep quality
Caregiver-rated child sleep quality

Secondary Outcome Measures

Child behavior problems (after 14-day period)
Change in caregiver-rated daily child behavior problems
Caregiver emotional stress (after 14-day period)
Change in caregiver-reported caregiver daily caregiver stress levels.
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.
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

Full Information

First Posted
December 24, 2017
Last Updated
August 11, 2021
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT03392844
Brief Title
Impact of Beds for Kids Program on Child Sleep
Official Title
Beds for Kids Program: Impact on Child Sleep and Family Functioning in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
February 3, 2020 (Actual)
Study Completion Date
February 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insufficient Sleep Syndrome, Inadequate Sleep Hygiene, Child Behavior Problems, Emotional Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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).
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention: Bed after 7 days
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list: Bed after 14 days
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Beds for Kids program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Child sleep duration
Description
Actigraph-derived child sleep duration in hours
Time Frame
14 day period
Title
Child sleep time variability
Description
Standard deviation of actigraph-derived child sleep time
Time Frame
14-day period
Title
Child sleep quality
Description
Caregiver-rated child sleep quality
Time Frame
14-day period
Secondary Outcome Measure Information:
Title
Child behavior problems (after 14-day period)
Description
Change in caregiver-rated daily child behavior problems
Time Frame
14-day period
Title
Caregiver emotional stress (after 14-day period)
Description
Change in caregiver-reported caregiver daily caregiver stress levels.
Time Frame
14-day period
Title
Child sleep duration at one-month follow-up
Description
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
Title
Child behavior problems at one-month follow-up
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Months
Maximum Age & Unit of Time
71 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ariel A Williamson, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Citation
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Impact of Beds for Kids Program on Child Sleep

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