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Impact of Bed Provision and Sleep Education

Primary Purpose

Sleep Disturbance, Sleep Deprivation, Sleep

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enhanced Sleep Health Education
Beds for Kids Standard Program
Sponsored by
Saint Joseph's University, Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disturbance

Eligibility Criteria

8 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Caregiver participant is the parent or legal guardian of the child participant.
  • Caregiver/legal guardian is 18 years of age.
  • Child between 8 and 12 years of age.
  • English-speaking

Exclusion Criteria:

  • Caregiver is not parent or legal guardian of child participant.
  • Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder, Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep.
  • Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non- compliant with study schedules or procedures.

Sites / Locations

  • Saint Joseph's University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced Sleep Health Education

Beds for Kids Standard Program

Arm Description

50 families will be randomly assigned to receive sleep health education delivered in two telephone sessions by Beds for Kids staff members, in addition to receiving the standard Beds for Kids program (bed, bedding, written sleep education materials). The first session will occur approximately 2-3 days before bed delivery. The second 15-20-minute session will occur approximately one week following bed delivery. Sleep health education training and supervision of Beds for Kids staff members will be provided by board-certified Behavioral Sleep Medicine providers. Sleep health information will be manualized and will consist of evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs.

50 families will be randomly assigned to the standard Beds for Kids program, which includes a bed, bedding, and written sleep education materials.

Outcomes

Primary Outcome Measures

Treatment acceptability: Treatment Evaluation Inventory-Short Form
Caregivers randomized to the enhanced sleep health education arm will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Beds for Kids intervention. Caregivers will complete an electronic survey with questions related to aspects of the intervention including perceived efficacy/helpfulness and acceptability of the intervention. Seven items will be rated on a 5-point Likert scale from 1 'strongly disagree' and to 5 'strongly agree' with total scores ranging from 1 to 35 (higher scores denoting higher acceptability). In addition, the percent of participants who indicate they "agree" or "strongly agree" for each of the 4 items (acceptability of measures) and 3 items (helpfulness) will be reported.
Sleep health-related behaviors
The Pediatric Sleep Practices Questionnaire is a 7 item measure related to sleep health-related practices, including bedtime routine consistency, the use of electronics prior to bedtime, sleep schedule regularity, and parental presence at bedtime, resulting in three subscales: total sleep timing (range 0-4), total routines/consistency (range 0-6), and total sleep environment (range 0-6). Two additional subscales include technology usage before bed (range 0-4) and the child's need for someone to fall asleep with them (range 0-2). Total scores range from 0 to 22. Higher scores denote poorer sleep practices.
Sleep outcomes
Children and their caregivers will report on child sleep disturbance and sleep-related impairments, using the reliable and valid Patient-Reported Outcomes Measurement Information System (PROMIS) self-and caregiver-proxy-report scales for pediatric sleep. To measure sleep disturbance, the PROMIS Parent Proxy Sleep Disturbance - Short Form 8a and the PROMIS Pediatric Sleep Disturbance - Short Form 8a will be completed. For the measurement of impairments of daily function related to lack of sleep, the PROMIS Parent Proxy Sleep-Related Impairment - Short Form 8a and the PROMIS Pediatric Sleep-Related Impairment - Short Form 8a will be completed. Items on all four assessments are rated on a 5-point Likert scale from 1 'never' to 5 'always,' with total sum scores for each measure ranging from 1 to 40 (higher scores denoting greater sleep disturbance or impairment). Scores will be converted into normative-based T-scores.

Secondary Outcome Measures

Family engagement
Family engagement will be based on percent completion of sleep education phone calls (possible range = 0-100%) for the intervention group.

Full Information

First Posted
August 16, 2020
Last Updated
April 28, 2023
Sponsor
Saint Joseph's University, Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT04536766
Brief Title
Impact of Bed Provision and Sleep Education
Official Title
Impact of Bed Provision and Enhanced Sleep Health Education on Sleep in Socio-economically Disadvantaged Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 24, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Saint Joseph's University, Philadelphia

4. Oversight

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

5. Study Description

Brief Summary
Investigators will recruit up to 100 families (children aged 8-12 years and their primary caregivers) from the Philadelphia-area Beds for Kids charity program, which provides beds, bedding, and sleep education to lower-socioeconomic status (SES) children. The primary objective of this randomized controlled trial is to determine whether bed provision combined with provider-delivered sleep health education can improve sleep in children participating in the Beds for Kids program.
Detailed Description
Insufficient and poor-quality sleep impacts more than half of school-aged children, and is associated with significant impairments in child neurocognitive, academic, behavioral, and physical health functioning. Lower socioeconomic status (SES) children are at increased risk for poor sleep. Compared to their higher-SES peers, lower-SES youth tend to obtain less sleep overall and experience worse sleep quality. Many children of lower-SES also may live in noisy or high-violence neighborhoods and in overcrowded homes that lack a child bed or other designated child sleep space. These environmental factors may perpetuate SES-related health disparities in child sleep duration, quality, and poor sleep health behaviors (i.e., bedroom electronics). Although there is a robust evidence-base for treating childhood sleep problems, there is a paucity of sleep intervention research focused on lower-SES children. Beds for Kids is a Philadelphia-area program that is part of the larger volunteer organization, One House at a Time, that provides lower-SES children with beds, bedding, and a sleep education brochure. To qualify for program participation, youth must be: (1) between the ages of 2 and 20 years, (2) living without an individual bed (e.g., sleeping on the floor, on a sofa, or crowded into one bed with family members), and (3) living in a household whose income is at or below 100 percent of the United States poverty threshold. The program accepts referrals from area social service agencies in the greater Philadelphia area.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disturbance, Sleep Deprivation, Sleep, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
100 Caregiver-child dyads (children ages 8-12 years) will be recruited from the Beds for Kids program.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Sleep Health Education
Arm Type
Experimental
Arm Description
50 families will be randomly assigned to receive sleep health education delivered in two telephone sessions by Beds for Kids staff members, in addition to receiving the standard Beds for Kids program (bed, bedding, written sleep education materials). The first session will occur approximately 2-3 days before bed delivery. The second 15-20-minute session will occur approximately one week following bed delivery. Sleep health education training and supervision of Beds for Kids staff members will be provided by board-certified Behavioral Sleep Medicine providers. Sleep health information will be manualized and will consist of evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs.
Arm Title
Beds for Kids Standard Program
Arm Type
Active Comparator
Arm Description
50 families will be randomly assigned to the standard Beds for Kids program, which includes a bed, bedding, and written sleep education materials.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Sleep Health Education
Intervention Description
The intervention comprehensively addresses poor sleep health behaviors. Personalized sleep health education will be delivered in two telephone sessions by Beds for Kids staff members. Sleep health information will consist of the following evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a family bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs. Personalization will be accomplished via direct questions to families during the education phone call related to their own barriers to achieving healthy sleep habits and goals for optimal sleep.
Intervention Type
Behavioral
Intervention Name(s)
Beds for Kids Standard Program
Intervention Description
The Beds for Kids program provides beds, bedding, and written healthy sleep education to families living at or below 100% of the federal poverty line and without an individual child bed to sleep in.
Primary Outcome Measure Information:
Title
Treatment acceptability: Treatment Evaluation Inventory-Short Form
Description
Caregivers randomized to the enhanced sleep health education arm will complete the Treatment Evaluation Inventory-Short Form, a widely used measure of treatment acceptability that has been adapted for the purposes of the Beds for Kids intervention. Caregivers will complete an electronic survey with questions related to aspects of the intervention including perceived efficacy/helpfulness and acceptability of the intervention. Seven items will be rated on a 5-point Likert scale from 1 'strongly disagree' and to 5 'strongly agree' with total scores ranging from 1 to 35 (higher scores denoting higher acceptability). In addition, the percent of participants who indicate they "agree" or "strongly agree" for each of the 4 items (acceptability of measures) and 3 items (helpfulness) will be reported.
Time Frame
2 months
Title
Sleep health-related behaviors
Description
The Pediatric Sleep Practices Questionnaire is a 7 item measure related to sleep health-related practices, including bedtime routine consistency, the use of electronics prior to bedtime, sleep schedule regularity, and parental presence at bedtime, resulting in three subscales: total sleep timing (range 0-4), total routines/consistency (range 0-6), and total sleep environment (range 0-6). Two additional subscales include technology usage before bed (range 0-4) and the child's need for someone to fall asleep with them (range 0-2). Total scores range from 0 to 22. Higher scores denote poorer sleep practices.
Time Frame
2 months
Title
Sleep outcomes
Description
Children and their caregivers will report on child sleep disturbance and sleep-related impairments, using the reliable and valid Patient-Reported Outcomes Measurement Information System (PROMIS) self-and caregiver-proxy-report scales for pediatric sleep. To measure sleep disturbance, the PROMIS Parent Proxy Sleep Disturbance - Short Form 8a and the PROMIS Pediatric Sleep Disturbance - Short Form 8a will be completed. For the measurement of impairments of daily function related to lack of sleep, the PROMIS Parent Proxy Sleep-Related Impairment - Short Form 8a and the PROMIS Pediatric Sleep-Related Impairment - Short Form 8a will be completed. Items on all four assessments are rated on a 5-point Likert scale from 1 'never' to 5 'always,' with total sum scores for each measure ranging from 1 to 40 (higher scores denoting greater sleep disturbance or impairment). Scores will be converted into normative-based T-scores.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Family engagement
Description
Family engagement will be based on percent completion of sleep education phone calls (possible range = 0-100%) for the intervention group.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Caregiver participant is the parent or legal guardian of the child participant. Caregiver/legal guardian is 18 years of age. Child between 8 and 12 years of age. English-speaking Exclusion Criteria: Caregiver is not parent or legal guardian of child participant. Presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder, Trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep. Caregivers/guardians or subjects who, in the opinion of the Investigator, may be non- compliant with study schedules or procedures.
Facility Information:
Facility Name
Saint Joseph's University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19131
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26551999
Citation
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Results Reference
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PubMed Identifier
22545685
Citation
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Results Reference
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PubMed Identifier
26779564
Citation
Buxton OM, Chang AM, Spilsbury JC, Bos T, Emsellem H, Knutson KL. Sleep in the modern family: protective family routines for child and adolescent sleep. Sleep Health. 2015 May 1;1(1):15-27. doi: 10.1016/j.sleh.2014.12.002.
Results Reference
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PubMed Identifier
25701537
Citation
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.
Results Reference
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PubMed Identifier
20093054
Citation
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Results Reference
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PubMed Identifier
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Citation
El-Sheikh M, Bagley EJ, Keiley M, Elmore-Staton L, Chen E, Buckhalt JA. Economic adversity and children's sleep problems: multiple indicators and moderation of effects. Health Psychol. 2013 Aug;32(8):849-59. doi: 10.1037/a0030413. Epub 2012 Nov 12.
Results Reference
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PubMed Identifier
29546286
Citation
Forrest CB, Meltzer LJ, Marcus CL, de la Motte A, Kratchman A, Buysse DJ, Pilkonis PA, Becker BD, Bevans KB. Development and validation of the PROMIS Pediatric Sleep Disturbance and Sleep-Related Impairment item banks. Sleep. 2018 Jun 1;41(6). doi: 10.1093/sleep/zsy054.
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Citation
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Results Reference
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Kelley ML, Heffer RW, Gresham FM, Elliott SN. Development of a modified treatment evaluation inventory. Journal of Psychopathology and Behavioral Assessment. 1989;11(3):235-247.
Results Reference
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PubMed Identifier
29401314
Citation
Miller MA, Kruisbrink M, Wallace J, Ji C, Cappuccio FP. Sleep duration and incidence of obesity in infants, children, and adolescents: a systematic review and meta-analysis of prospective studies. Sleep. 2018 Apr 1;41(4). doi: 10.1093/sleep/zsy018.
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Citation
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.
Results Reference
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Impact of Bed Provision and Sleep Education

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