Incorporation of Safe Sleep Education Into m-Health Technology

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06074211
Status
Recruiting
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Conditions

  • Sudden Infant Death

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Safety in Seconds mobile app: Safe Sleep Education — BEHAVIORAL
    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 — BEHAVIORAL
    The Safety in Seconds mobile app is a platform previously developed to deliver targeted injury prevention education, including fire and car seat safety.

Study Details

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.

Key Dates

First listed
Oct 10, 2023
Start date
Jul 1, 2025
Status verified
Jul 2026
Primary completion
Sep 30, 2026
Completion
May 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of MedicineBaltimoreMaryland21287-

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By research site
Johns Hopkins School of Medicine· Baltimore, MD

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