Recruiting

Safety in Seconds

Sponsor:

Johns Hopkins University

Code:

NCT06074211

Conditions

Sudden Infant Death

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Safety in Seconds mobile app: Safe Sleep Education

Safety in Seconds mobile app: Car Seat Safety Education

Study Details

Brief summary:

Sudden Unexplained Infant Death (SUID) is the leading cause of death in infants age 28 days to 1 year. Protective factors, such as supine positioning, firm sleep surface, breastfeeding, pacifier use, elimination of soft objects from the sleep space, and avoidance of tobacco, alcohol, and illicit drugs have been shown to decrease the risk. The American Academy of Pediatrics recommends that healthcare providers model and convey safe sleep practices during patient encounters. Pediatric emergency departments (PED) serve as front-line contact for populations at greatest risk for SUID, however few interventions have been tested in the PED setting. M- Health (mobile health) apps have previously demonstrated the ability to deliver safety education to parents and are well suited for use in the PED given limited clinician time and long wait times. Safety in Seconds (SIS) is a theory based, m-Health injury prevention tool focused on care seat safety and fire safety with previously demonstrated effectiveness in an NIH-funded randomized trial. This study aims to add safe sleep education into the SIS, and subsequently disseminate the app in the PED setting. Integration of safe sleep education into SIS represents an opportunity to increase safe sleep knowledge and practices through a proven effective m-Health intervention. This study addresses this potential by incorporating a previously developed, theory-driven and evidence-based safe sleep education into the SIS app and testing the feasibility of deployment in the PED.

Conditions

Sudden Infant Death

Study ID

NCT06074211

Start date

Jul 1, 2025

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • English speaking caregivers over 18 of infants age 0-4 months
  • Use a smart phone

Exclusion Criteria:

  • Non English speaking
  • Under 18 years of age or unable to consent for themselves
  • High acuity, critical care needs of infant patient that would limit participation during initial PED visit.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Safe Sleep Education

The intervention group will receive safe sleep education via the Safety in Seconds mobile app.

active comparator: Car seat safety

The attention matched control group will receive car seat safety education via the Safety in Seconds mobile app.

Interventions

Safety in Seconds mobile app: Safe Sleep Education

The Safety in Seconds mobile app is a platform previously developed to deliver targeted injury prevention education. This intervention will be testing the effectiveness of a newly developed educational module on safe sleep education.

Safety in Seconds mobile app: Car Seat Safety Education

The Safety in Seconds mobile app is a platform previously developed to deliver targeted injury prevention education, including fire and car seat safety.

Primary outcome measure

  • Change in Safe sleep behaviors as assessed by survey developed by study team [ Time Frame: Baseline, 1 month ]

Central Contacts and Locations

Central contacts

Mary Beth Howard, MD, MSc

443-287-7207mhowar50@jh.edu

Locations

Johns Hopkins School of Medicine

Recruiting

Baltimore, Maryland, United States, 21287

More Information

Sponsor

Johns Hopkins University

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-07-15.