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Enhanced Sleep Health Education for Sleep Disorder

N/A
Waitlist Available
Research Sponsored by Saint Joseph's University, Philadelphia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Caregiver participant is the parent or legal guardian of the child participant.
Caregiver/legal guardian is 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will provide beds and sleep education to lower-socioeconomic status children to see if it improves their sleep.

Eligible Conditions
  • Sleep Disorder
  • Insomnia
  • Sleep
  • Sleep Deprivation

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep health-related behaviors
Sleep outcomes
Treatment acceptability: Treatment Evaluation Inventory-Short Form
Secondary outcome measures
Family engagement

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Sleep Health EducationExperimental Treatment1 Intervention
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.
Group II: Beds for Kids Standard ProgramActive Control1 Intervention
50 families will be randomly assigned to the standard Beds for Kids program, which includes a bed, bedding, and written sleep education materials.

Find a Location

Who is running the clinical trial?

Saint Joseph's University, PhiladelphiaLead Sponsor
2 Previous Clinical Trials
130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do the eligibility requirements for this clinical research extend to individuals over seventy years of age?

"This clinical trial stipulates that participants must be aged between 8 and 12 years old."

Answered by AI

Can I partake in this research protocol?

"Prerequisite for participating in this study is the presence of sleep debt and being between 8-12 years old. The total amount of enrollees will be two hundred individuals."

Answered by AI

Is this experiment actively searching for new participants?

"The research posted on clinicaltrials.gov attests that this medical investigation is no longer seeking applicants for participation. Initially launched in October of 2020, it was last modified in May 2022; nevertheless, there are currently 418 alternative trials actively looking to enrol patients."

Answered by AI
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~45 spots leftby Mar 2025