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Completed

NCT Number: NCT04536766

Impact of Bed Provision and Sleep Education

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.

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Key information

Conditions

Sleep Disturbance Dyssomnias Insomnia Mental Disorders Nervous System Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Sleep Deprivation Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Joseph's University

Philadelphia, Pennsylvania, 19131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced Sleep Health Education

Behavioral

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.

Beds for Kids Standard Program

Behavioral

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 outcomes

  1. Treatment acceptability: Treatment Evaluation Inventory-Short Form

    Time frame: 2 months

    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.

  2. Sleep health-related behaviors

    Time frame: 2 months

    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.

  3. Sleep outcomes

    Time frame: 2 months

    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 outcomes

  1. Family engagement

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Saint Joseph's University, Philadelphia

Other

Registry information

Official study title

Impact of Bed Provision and Enhanced Sleep Health Education on Sleep in Socio-economically Disadvantaged Children

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 3, 2020
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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