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Recruiting NCT07515534

Effect of Early Parent Education on Children's Sleep

No phase Interventional Sleep

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep Information and Advice 1, Sleep Information and Advice 2.
Who it may be relevant to
Registry conditions: Sleep. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effect of Early Parent Education on Children's Sleep: Beyond Risk Factors

Overview

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.

Interventions

  • Behavioral Sleep Information and Advice 1
    All participants will receive sleep information and advice
  • Behavioral Sleep Information and Advice 2
    All participants will receive sleep information and advice.

Primary outcome measures

  • Total sleep duration [Time frame: From infant's birth to the end of intervention at 24-months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Chicago — Chicago

Identifiers

NCT: NCT07515534 · IRB24-2167

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗