Safety in Seconds 2.0: An App to Increase Car Seat Use

Injuries Clinical Trial

Official title:

Evaluating a Web-based Child Passenger Safety Program: Safety in Seconds 2.0

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02345941
• Other study ID #: HD069221-01A1
• Status: Completed
• Phase: N/A
• First received: January 14, 2015
• Last updated: December 22, 2016
• Start date: July 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2016
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This project will utilize the first web-based program to provide tailored injury prevention education. The existing Safety in Seconds program was adapted into a smartphone platform. Parents are recruited from and engage in the program in the clinical setting (PED or PTS). Parents download the app onto their smartphone which is used to ask the questions, collect a parent's responses, assess the parents' safety needs and give tailored directions for proper car sear use. The control group parents will also engage with the smartphone app and receive immediate feedback. However, they will receive tailored educational messages about smoke alarms. Parents will also have access to the online SIS v 2.0 Parent Portal which will have educational features (e.g., tips for keeping children content in their CSSs, links to helpful websites). The investigators will use emerging technology such as push notification and email to remind parents to visit the portal and have their child's car seat reassessed.

The investigators plan to conduct a cost benefit analysis of the program's expected financial benefit from the perspective of a third party payer of medical claims and an in-depth examination of program adoption and implementation using qualitative data collected from key informant interviews, direct observations of the clinic environments, and document review.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1129
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Visiting the Pediatric Emergency Department (PED) at Johns Hopkins Hospital or Arkansas Children's Hospital

• Parent or guardian of child 4-7 years

• English speaking

• Have and Android or iPhone smartphone

• Drive with the child in a car at least once per week in a car that the parent owns, borrows or gets a ride round-trip

• Resident of Baltimore City, MD or Little Rock, AR and surrounding area.

Exclusion Criteria:

• PED has flagged case as suspected abuse

• Another household member is enrolled in the study

• In Arkansas, less than 18 years without parent present at the PED

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Injuries

Intervention

Other:
• Parent Action Report
Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.
• Parent Portal
Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Public Health	Baltimore	Maryland
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline self-reported car seat use at 6 months	Self-reported measures include the type of car seat used (rear-facing car seat, forward-facing car seat, booster seat, or seat belt), the location in car where it is used (front seat or backseat), frequency of use (some of the time or all of the time) and having the seat inspected by a car seat technician.	6 months	No
Secondary	Change from baseline self-reported smoke alarm use at 6 months	Self-reported measures include having a smoke alarm on every level of the home, having long-life battery alarms in the home, having a fire escape plan and practicing the fire escape plan.	6 months	No