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Sleep Well Bee Well for Pediatric Sleep Disorder

N/A
Waitlist Available
Led By Monica Ordway, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights

Study Summary

This trial is testing a 3-week sleep intervention for 1-2.5 year olds to see if it improves sleep and parent wellbeing.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 21 days 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 Bedtime Routine
Change in Bedtime Variability
Change in Children's Bedtime Routine
+4 more
Secondary outcome measures
Change in Depressive symptoms among parents
Change in Parental knowledge and beliefs about children's sleep
Change in Parenting stress
+2 more
Other outcome measures
Change in Parent-Teacher Involvement
Change in Parental Physical and Mental Health
Change in Self-report of parents' hopefulness
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sleep Well Bee WellExperimental Treatment1 Intervention
Sleep program to help toddlers sleep better
Group II: Wait-list ControlPlacebo Group1 Intervention
The wait-listed group will begin the intervention after the intervention group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleep Well Bee Well
2022
N/A
~100

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,430 Total Patients Enrolled
National Institute of Nursing Research (NINR)NIH
579 Previous Clinical Trials
10,376,284 Total Patients Enrolled
Monica Ordway, PhDPrincipal InvestigatorAssociate Professor of Nursing

Frequently Asked Questions

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

What are the key aims of this clinical experiment?

"This 21-day study will measure the efficacy of its intervention by evaluating Change in Bedtime Routine, Change in Parenting Stress (assessed with a 36-item questionnaire administered three times over 10 minutes), Change in Parental Knowledge and Beliefs about Children's Sleep (7 self-efficacy items rated from 0 to 76 also collected thrice during the trial) and Change in Depressive Symptoms among Parents (with 20 CES-D items out of which 16 or more qualify as impairment). It is expected that these metrics will improve upon completion of the SWBW treatment."

Answered by AI

Are there any remaining opportunities to join this scientific experiment?

"Clinicaltrials.gov reports that, as of 10/3/2022, this trial has ceased recruitment and is not actively seeking patients. Nevertheless, there are 1 other studies still recruiting candidates at the moment."

Answered by AI
~32 spots leftby Apr 2025