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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03965377
Other study ID # STUDY00008278
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 6, 2019
Est. completion date December 30, 2022

Study information

Verified date December 2021
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test the effectiveness of novel technology-based game to teach parents and parents to be home safety skills. These include the identification of home child injury risks under two conditions (with and without distraction) and how to resolve these risks to better protect preschool children from injuries. Few empirically validated home safety interventions exist and the best ones involve individual home visitors. These and others that use didactic instruction or provision of written material have poor response from low socioeconomic parents who are less literate and more resistant to outsiders entering their homes. The use of a computer game to provide education in this area is being tested for effectiveness and the game's engagement will also be examined. Given cognitive problems in parents have been linked in the PI's work to child neglect (e.g., poor child supervision), links of performance on the game to cognitive capacities will also be examined in a preliminary way.


Description:

The study will compare a group of parents and parents to be who play the game multiple times (n=15) to a wait list group (n=15) who just play it once. The study will examine reaction times to identification and resolution of the risks overall and by category of risk (e.g., poisoning, burns, suffocation, etc.). The study will also examine failures on levels of the game which are graded for difficulty. The game was designed for low failure rate to increase engagement and to improve motivation. Changes in the participants' perception of efficacy in preventing injuries to children and their engagement with the game (using a standardized usability survey) will be examined. The study will also examine the role of experience with the use of technology and cognitive capacities in relation to performance and pre-post changes with multiple plays of the game.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 30
Est. completion date December 30, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years to 20 Years
Eligibility Inclusion Criteria:participants who are parents or parents to be from a high school program in Altoona, PA. For those less than age 18, parental permission for participation is required - Exclusion Criteria: non-English Speaking; ones whose due date falls in the study period and who are not likely to complete the project.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Home Safety Hero Computer Game
Home Safety Hero computer game presents players with virtual rooms in a home where vilians have planted safety risks. It involves the player taking the role of a body guard for a child. It has three phases: 1. Identifying risks in a set of rooms (e.g., burn, falling, suffocation, poisoning); 2. Identifying risks and then selecting a resolution to reduce the risk or eliminate it entirely; and 3. Identifying risk when faced with distractions typical to home environments (e.g., phone ringing, fire engine siren sounds, a moving child).

Locations

Country Name City State
United States Sandra T. Azar University Park Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Learning The game is designed to improve speed of identifying home safety hazards with and without distractions and also identify effective resolutions of the risks. Speed in identification is measured in seconds. Effectiveness in identifying resolutions is measured in seconds as well (e.g., seconds til correct response). Average time to identification of risks in each of the three phases of the game can be computed (Identification Phase, Resolution Phase, and Distraction Phase). The game will also give whether the resolutions selected are correct and thus, a percentage of correct resolutions can be computed for the entire resolution phase. one week (four plays of the game) The outcomes average seconds until identification will be examined across the four game plays and also can be examined for each of four plays of the game.
Secondary :Perception of efficacy in preventing childhood injuries: PARENT SENSE OF INJURY COMPETENCE SCALE The participants' change in perception of efficacy in preventing childhood injuries pre and one week later This outcome will be measured using PARENT SENSE OF INJURY COMPETENCE SCALE. This instrument has 16 items that are rated on a 1-6 scale with 6 indicating greater efficacy. The items are totaled for overall efficacy perception.
Secondary Engagement in the game A survey instrument [Usability Survey (UES)] will be collected that measures engagement in the game. This instrument has 26 items that assess engagement with the game rated on a five point scale from strongly disagree (1) to strongly agree (5). The ratings are totalled for an overall engagement score and this will be used to measure engagement. This instrument is collected one time at post test once they have completed game play. The time frame is one week after entering the study.
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