Make Safe Happen App Evaluation Study

NCT02751203 | Completed

• 1 other identifier: IRB16-00119
• Study Type: interventional
• Target: 5,085
• Locations: 0 countries
• Sites: N/A

Brief Summary

Unintentional injury is the leading cause of death for young children in the United States (U.S.) and is responsible for more child deaths than they next three causes combined, that is, homicide, suicide, and cancer. Each year approximately 9,000 children die, 250,000 are hospitalized and more than 9,000,000 children are treated in emergency departments for preventable injuries. Child and adolescent unintentional injury deaths have not declined to the same extent that other diseases have, and resources directed at reducing child injury are not commensurate with the burden it poses. More than 50% of these injuries occur in and around the home, where young children spend most of their time. Unlike diseases such as cancer, there is no need to wait on a cure...there already is one. Many of these injuries can be prevented through the use of safety equipment and by following safety recommendations. Using known, effective countermeasures can prevent or reduce the consequences of a child being injured yet these devices are not routinely utilized. Barriers related to identifying hazards, finding credible information and recommendations, and obtaining the safety products best-suited to the features of your home make creating a safe home challenging for caregivers. Interventions for increasing home safety behaviors have ranged from educational materials, health care provider counseling, safety product distribution, hands-on experiential learning in a safety resource center--these have all been evaluated with varying degrees of effectiveness, however, wide-reaching interventions to reach large/substantial caregiver audiences, are needed. Offering tailored safety information on multiple topics via a single platform, combined with the ability to acquire safety devices, is a more efficient means to reach a large segment of the population and may help reduce the aforementioned barriers. Thus, there is an urgent need for mobile technologies to reduce barriers by helping parents identify injury hazards in their homes, consolidate credible injury prevention recommendations, organize information by room or feature, tailor by child age, facilitate the acquisition and installation of safety products, encourage and track progress, thereby increasing the likelihood that parents accomplish these important life-saving safety tasks.

Conditions

Health Knowledge,Practices,Attitudes

Outcome Measures

Primary Outcomes (1)

• Safety Knowledge Score

  A safety knowledge score will be calculated by summing the number of correct answers collected from 10-12 questions regarding the participant's safety knowledge. These will be asked at both the pre and post test. Scores will be compared over time and between groups.

  2 weeks

Secondary Outcomes (1)

• Behavioral Intention assessed by using the Health Belief Model

  2 weeks

Other Outcomes (1)

• Number of safety devices

  2 weeks

Study Arms (2)

Make Safe Happen App Intervention

EXPERIMENTAL

Pre- and post-test delivered to online survey panel participants. Instruction to download and use the intervention (Make Safe Happen Mobile App) for 1 week.

Behavioral: Make Safe Happen App

Make Safe Happen App Control

NO INTERVENTION

A subset of online survey panel participants (n=200) will complete a pre- and post-test survey but will receive a non-safety app (e.g. a free recipe app). After the study, participants will be asked to download the intervention app.

Interventions

Make Safe Happen App BEHAVIORAL

The Make Safe Happen app is a mobile app (available for free download android and iOS) developed by the safety experts in the Center for Injury Research and Policy. Parents and caregivers can use the app to learn how to make their homes safer with room-to-room safety checklists and links to recommended products. App users can also create to-do lists, set reminders and track their progress.

Make Safe Happen App Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a smart phone (iOS or Android)
• have willingness to download and install a free mobile application
• parents must be comfortable answering questions online, in English
• parent or legal guardian (male or female) of a child 0-12 years, who lives with them most of the time.

You may not qualify if:

• have previously downloaded or used the Make Safe Happen® app.
• have participated in other parts of the study (ie.Online survey participants will not be eligible for participation in the parent focus groups or home observations).

Sponsors & Collaborators

• Lara McKenzie: lead

Related Publications (2)

• McKenzie LB, Roberts KJ, McAdams RJ, Abdel-Rasoul M, Kristel O, Szymanski A, Keim SA, Shields WC. Efficacy of a mobile technology-based intervention for increasing parents' safety knowledge and actions: a randomized controlled trial. Inj Epidemiol. 2021 Oct 1;8(1):56. doi: 10.1186/s40621-021-00350-w.

  PMID: 34593040 DERIVED

• McKenzie LB, Roberts KJ, Clark R, McAdams R, Abdel-Rasoul M, Klein EG, Keim SA, Kristel O, Szymanski A, Cotton CG, Shields WC. A randomized controlled trial to evaluate the Make Safe Happen(R) app-a mobile technology-based safety behavior change intervention for increasing parents' safety knowledge and actions. Inj Epidemiol. 2018 Mar 12;5(1):5. doi: 10.1186/s40621-018-0133-3.

  PMID: 29527644 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 26, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share