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Bedtime Routine Education for Sleep Disorder

N/A
Waitlist Available
Led By Megan Heere, MD
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
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15-month and 24-month visits
Awards & highlights

Study Summary

This trial will study how well a bedtime routine program improves sleep and developmental outcomes in low-income toddlers.

Eligible Conditions
  • Sleep Disorder
  • Child Development
  • Sleep

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15-month and 24-month visits
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15-month and 24-month visits for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in sleep outcomes
Secondary outcome measures
Developmental outcomes
Parent stress
Socio-emotional outcomes
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bedtime Routine EducationExperimental Treatment1 Intervention
50 families will be randomly assigned to receive the bedtime routine intervention, 3 Cs for Bedtime ZZZs delivered by research assistants at the 12-month and 15-month well-child visits, in additional to receiving usual clinical care. The intervention will take approximately 30-45 minutes to implement at each study visit. Research assistants will be trained and supervised by board-certified Behavioral Sleep Medicine providers. This intervention focuses on developing an individualized bedtime routine, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling, based on parent's preferences. Families will receive appropriate materials for their bedtime routine, including a CuddleBright kit, bedtime books, toothbrush/toothpaste, and the created bedtime chart to take home.
Group II: Control groupActive Control1 Intervention
50 families will be randomly assigned to control group (usual care).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bedtime Routine Education
2020
N/A
~100

Find a Location

Who is running the clinical trial?

Temple UniversityOTHER
297 Previous Clinical Trials
82,873 Total Patients Enrolled
CuddleBright CaresUNKNOWN
Johnson & Johnson Consumer Inc. (J&JCI)Industry Sponsor
52 Previous Clinical Trials
5,394 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Impact of Bedtime Routines on Sleep and Development in Toddlers
2020. "Impact of Bedtime Routines on Sleep and Development in Toddlers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04592172.
~23 spots leftby Apr 2025
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