Incorporation of Safe Sleep Education Into m-Health Technology

NCT06074211 | Active Not Recruiting

• 1 other identifier: IRB00362756
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Safe sleep behaviors as assessed by survey developed by study team

  Safe sleep behaviors will be measured by the number of participants who adapt safe sleep behaviors.

  Baseline, 1 month

Study Arms (2)

Safe Sleep Education

EXPERIMENTAL

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

Behavioral: Safety in Seconds mobile app: Safe Sleep Education

Car seat safety

ACTIVE COMPARATOR

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

Behavioral: Safety in Seconds mobile app: Car Seat Safety Education

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.

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.

Car seat safety

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• American SIDS Institute: collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (7)

• Moon RY, Carlin RF, Hand I; TASK FORCE ON SUDDEN INFANT DEATH SYNDROME AND THE COMMITTEE ON FETUS AND NEWBORN. Sleep-Related Infant Deaths: Updated 2022 Recommendations for Reducing Infant Deaths in the Sleep Environment. Pediatrics. 2022 Jul 1;150(1):e2022057990. doi: 10.1542/peds.2022-057990.

  PMID: 35726558 BACKGROUND

• Allen K, Anderson TM, Chajewska U, Ramirez JM, Mitchell EA. Factors associated with age of death in sudden unexpected infant death. Acta Paediatr. 2021 Jan;110(1):174-183. doi: 10.1111/apa.15308. Epub 2020 May 12.

  PMID: 32304589 BACKGROUND

• Carlin RF, Moon RY. Risk Factors, Protective Factors, and Current Recommendations to Reduce Sudden Infant Death Syndrome: A Review. JAMA Pediatr. 2017 Feb 1;171(2):175-180. doi: 10.1001/jamapediatrics.2016.3345.

  PMID: 27918760 BACKGROUND

• Canter J, Rao V, Patrick PA, Alpan G, Altman RL. The impact of a hospital-based educational video on maternal perceptions and planned practices of infant safe sleep. J Spec Pediatr Nurs. 2015 Jul;20(3):187-92. doi: 10.1111/jspn.12114. Epub 2015 Apr 21.

  PMID: 25898856 BACKGROUND

• McDonald EM, Davani A, Price A, Mahoney P, Shields W, Musci RJ, Solomon BS, Stuart EA, Gielen AC. Health education intervention promoting infant safe sleep in paediatric primary care: randomised controlled trial. Inj Prev. 2019 Jun;25(3):146-151. doi: 10.1136/injuryprev-2017-042421. Epub 2017 Sep 22.

  PMID: 28939661 BACKGROUND

• Gielen AC, McKenzie LB, McDonald EM, Shields WC, Wang MC, Cheng YJ, Weaver NL, Walker AR. Using a computer kiosk to promote child safety: results of a randomized, controlled trial in an urban pediatric emergency department. Pediatrics. 2007 Aug;120(2):330-9. doi: 10.1542/peds.2006-2703.

  PMID: 17671059 BACKGROUND

• Nansel TR, Weaver N, Donlin M, Jacobsen H, Kreuter MW, Simons-Morton B. Baby, Be Safe: the effect of tailored communications for pediatric injury prevention provided in a primary care setting. Patient Educ Couns. 2002 Mar;46(3):175-90. doi: 10.1016/s0738-3991(01)00211-7.

  PMID: 11932115 BACKGROUND

MeSH Terms

Conditions

Sudden Infant Death

Interventions

Safety

Condition Hierarchy (Ancestors)

Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infant Death

Intervention Hierarchy (Ancestors)

Accident Prevention; Accidents; Public Health; Environment and Public Health

Study Officials

• Mary Beth Howard, MD, MSc

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 10, 2023
• Study Start: July 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Locations

US (1)