- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07515534
Effect of Early Parent Education on Children's Sleep (WISH)
Effect of Early Parent Education on Children's Sleep: Beyond Risk Factors
The goal of this clinical trial is to learn if providing sleep information and advice to expecting parents can increase sleep duration and decrease sleep problems in infants. The main questions it aims to answer is:
- Does providing sleep information and advice to parents after birth enhance baby's total sleep duration over the 24-months study?
- Which study group has fewer sleep problems (bedtime resistance, night waking frequency and duration, difficulty with naps) over the 24-month period?
Participants will:
- Receive regularly scheduled sleep information and advice emails
- Complete weekly surveys for the first 8 weeks after birth
- Complete monthly online surveys up to 24 months
Researchers will compare both intervention groups to a control group that received no information and advice to see if the information and advice had an impact on the child's sleep.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hannah Boehm, MPH
- Phone Number: 773-702-1220
- Email: Hannah.Boehm@bsd.uchicago.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
-
Contact:
- UChicago IRB
- Phone Number: 773-702-6505
- Email: bsdirb@bsd.uchicago.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Currently pregnant
- Two-parent families or single-parent families
- Current or new patient at Weissbluth Pediatrics
Exclusion Criteria:
- Adopting parents
- Multiple pregnancy (twins, triplets, etc.)
- Siblings (one enrolled child per family)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
|
|
Experimental: Group 2
|
All participants will receive sleep information and advice.
|
|
Experimental: Group 1
|
All participants will receive sleep information and advice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total sleep duration
Time Frame: From infant's birth to the end of intervention at 24-months
|
From infant's birth to the end of intervention at 24-months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB24-2167
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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