- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02345941
Safety in Seconds 2.0: An App to Increase Car Seat Use
Evaluating a Web-based Child Passenger Safety Program: Safety in Seconds 2.0
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Arkansas
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Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins School of Public Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Invervention
The intervention group will get tailored information on the Parent Action Report and the Parent Portal about child safety seats and booster seats.
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Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.
Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.
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Active Comparator: Control
The control group will get tailored information in the Parent Action Report and the Parent Portal about smoke alarms.
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Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.
Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline self-reported car seat use at 6 months
Time Frame: 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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline self-reported smoke alarm use at 6 months
Time Frame: 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
|
Collaborators and Investigators
Investigators
- Study Director: Elise C Omaki, MHS, Johns Hopkins Bloomberg School of Public Health
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HD069221-01A1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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