Clinical trial NCT02345941: Safety in Seconds 2.0: An App to Increase Car Seat Use
Official title: Evaluating a Web-based Child Passenger Safety Program: Safety in Seconds 2.0
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 1129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline self-reported car seat use at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change from baseline self-reported smoke alarm use at 6 months
timeFrame: 6 months
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Baltimore
country: United States
facility: Johns Hopkins School of Public Health
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Andrea C Gielen, ScD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Elise C Omaki, MHS
role: STUDY_DIRECTOR
References:
citation: Gielen AC, Bishai DM, Omaki E, Shields WC, McDonald EM, Rizzutti NC, Case J, Stevens MW, Aitken ME. Results of an RCT in Two Pediatric Emergency Departments to Evaluate the Efficacy of an m-Health Educational App on Car Seat Use. Am J Prev Med. 2018 Jun;54(6):746-755. doi: 10.1016/j.amepre.2018.01.042. Epub 2018 Apr 12.
citation: Omaki E, Shields WC, McDonald E, Aitken ME, Bishai D, Case J, Gielen A. Evaluating a smartphone application to improve child passenger safety and fire safety knowledge and behaviour. Inj Prev. 2017 Feb;23(1):58. doi: 10.1136/injuryprev-2016-042161. Epub 2016 Sep 5.