214 Participants NeededMy employer runs this trial

Safe Sleep Education for Sudden Infant Death Syndrome

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: State University of New York at Buffalo
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Safe sleep recommendations from the American Academy of Pediatrics (AAP) are designed to reduce the risk of sudden infant death syndrome (SIDS) and other sleep-related infant deaths. These recommendations include placing infants on their backs to sleep, using a crib or bassinet, avoiding soft bedding, and not sharing a sleep space with other people.

Many families do not consistently follow all recommended safe sleep practices, particularly when infants are sick. Research has shown that educational programs provided in pediatric emergency departments can improve some safe sleep behaviors, but improvements have been limited and may not continue over time. Additional strategies are needed to help families adopt and maintain safe sleep practices.

The purpose of this study is to determine whether a daily safe sleep tracking tool, used together with brief safe sleep education, can improve caregivers' adherence to recommended safe sleep practices compared with education alone. The information learned from this study may help healthcare providers develop more effective ways to promote safe sleep and reduce the risk of sleep-related infant deaths.

Are You a Good Fit for This Trial?

This trial is for caregivers of infants who visit the pediatric emergency department. It aims to help families improve how they follow safe sleep guidelines to reduce the risk of sudden infant death syndrome (SIDS).

Inclusion Criteria

I am the legal guardian of an infant younger than 4 months old.
I can answer follow-up surveys by phone or email.
English speaking primary caregiver of infant
See 2 more

Exclusion Criteria

Non-English-speaking primary caregiver
My legal guardian cannot complete surveys or provide follow-up contact.
Legal guardian completely adherent to safe sleep guidelines
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Families receive a brief educational video on safe sleep and a handout summarizing infant safe sleep practices. The experimental group also receives habit tracking information and a form to track sleep behaviors.

Initial emergency department visit
1 visit (in-person)

Follow-up

Participants are monitored for adherence to safe sleep practices and other outcomes at 2 and 4 weeks after the initial intervention.

4 weeks
2 visits (virtual or in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Behavior habit tracking
  • Safe Sleep Education

Trial Overview

The study compares two approaches: one group receives brief education about safe sleep practices, while the other gets both this education and a daily tool to track their baby's sleep habits. The goal is to see which method helps families stick to safe sleep recommendations better.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Behavior Habit Tracking Plus Safe Sleep EducationExperimental Treatment2 Interventions
Group II: Safe Sleep EducationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials
279
Recruited
52,600+