NCT02345941

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,129

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 14, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 26, 2016

Status Verified

December 1, 2016

Enrollment Period

1.8 years

First QC Date

January 14, 2015

Last Update Submit

December 22, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Change from baseline self-reported smoke alarm use at 6 months

    6 months

Study Arms (2)

Invervention

EXPERIMENTAL

The intervention group will get tailored information on the Parent Action Report and the Parent Portal about child safety seats and booster seats.

Other: Parent Action ReportOther: Parent Portal

Control

ACTIVE COMPARATOR

The control group will get tailored information in the Parent Action Report and the Parent Portal about smoke alarms.

Other: Parent Action ReportOther: Parent Portal

Interventions

Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.

ControlInvervention

Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.

ControlInvervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Andrea C Gielen, ScD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR
  • Elise C Omaki, MHS

    Johns Hopkins Bloomberg School of Public Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 26, 2015

Study Start

July 1, 2014

Primary Completion

April 1, 2016

Study Completion

December 1, 2016

Last Updated

December 26, 2016

Record last verified: 2016-12

Locations