NCT03965377

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 6, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2019

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

3.6 years

First QC Date

April 10, 2019

Last Update Submit

December 6, 2021

Conditions

Keywords

effectiveness of gaming technologyknowledge of childhood injury prevention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • :Perception of efficacy in preventing childhood injuries: PARENT SENSE OF INJURY COMPETENCE SCALE

    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.

  • Engagement in the game

    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.

Study Arms (1)

Home Safety Hero game play

EXPERIMENTAL

Home Safety Hero is parental psychoeducational computer game to prevent childhood injuries

Behavioral: Home Safety Hero Computer Game

Interventions

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).

Home Safety Hero game play

Eligibility Criteria

Age12 Years - 20 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsBased on self-representation of gender identity
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra T. Azar

University Park, Pennsylvania, 16802, United States

Location

Study Officials

  • Sandra T Azar, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: teen parents and parents to be will be randomly assigned to game play (4 vs 1) to assess the effectiveness of the computer game to decrease time to identifying home hazards, improve identification of resolutions of hazards, and time to identify home hazards under distraction conditions
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2019

First Posted

May 29, 2019

Study Start

February 6, 2019

Primary Completion

August 31, 2022

Study Completion

December 30, 2022

Last Updated

December 8, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations