Effect of Early Parent Education on Children's Sleep | NCT07515534

Studies
Effect of Early Parent Education on Children's Sleep

NCT07515534

Sponsor

University of Chicago

Status

Recruiting

Last Update Posted

Apr 7, 2026Actual

Enrollment

391Estimated

Phase

Not Applicable

Conditions

Sleep

Interventions

Sleep Information and Advice 1
Sleep Information and Advice 2

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2026Actual

Primary Completion Date

Apr 30, 2029Estimated

Completion Date

Apr 30, 2029Estimated

First Submitted Date

Mar 31, 2026

First Submission Date that Met QC Criteria

Mar 31, 2026

First Posted Date

Apr 7, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 7, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

391Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group 1	Experimental	Behavioral: Sleep Information and Advice 1
Group 2	Experimental	Behavioral: Sleep Information and Advice 2
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sleep Information and Advice 1	Behavioral	All participants will receive sleep information and advice	Group 1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total sleep duration		From infant's birth to the end of intervention at 24-months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hannah Boehm, MPH	Contact	773-702-1220		Hannah.Boehm@bsd.uchicago.edu

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chicago	Recruiting	Chicago	Illinois	60637	United States