NCT04096196

Brief Summary

The project will design and develop a game for teaching safety as a way to reduce childhood injury. To evaluate the effectiveness of the designed game, a randomized controlled trial (RCT) following the CONSORT RCT guidelines will be conducted. All students in Primary 4-6 (equivalent to US Grades 4-6) from the participating school will be invited to join the trial, which will be then randomized into the game or health education group. All students in the game group will be invited to play the designed game with instructions provided, while those in health education group will receive a comprehensive package on safety information. The intervention will last 4 weeks, with the safety knowledge and behaviours, and psychosocial difficulties of the participants being assessed before and 1 and 3 months after the intervention. The effectiveness of the intervention in achieving the proposed targets will be estimated using linear mixed models.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

June 8, 2023

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

September 13, 2019

Last Update Submit

June 7, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Changes from baseline safety knowledge at 1 month

    Child safety knowledge will be measured by different items adopted from the existing literature and questionnaires under the three contexts: home safety, road safety, and sports-related safety. Child participants will be asked to indicate their level of involvement in the said behaviour on a 5-point Likert scale ranging from "Never" to "Very Often", or their agreement on the given statement based upon their own safety knowledge on a 4-point Likert scale ranging from "Strongly disagree" to "Strongly agree".

    At baseline and 1 and 3 months after the intervention

  • Changes from baseline safety knowledge at 3 months

    Child safety knowledge will be measured by different items adopted from the existing literature and questionnaires under the three contexts: home safety, road safety, and sports-related safety. Child participants will be asked to indicate their level of involvement in the said behaviour on a 5-point Likert scale ranging from "Never" to "Very Often", or their agreement on the given statement based upon their own safety knowledge on a 4-point Likert scale ranging from "Strongly disagree" to "Strongly agree".

    At baseline and 1 and 3 months after the intervention

  • Changes from baseline safety behaviours at 1 month

    Child safety behaviours will be measured by different items adopted from the existing literature and questionnaires under the three contexts: home safety, road safety, and sports-related safety. Child participants will be asked to indicate their level of involvement in the said behaviour on a 5-point Likert scale ranging from "Never" to "Very Often", or their agreement on the given statement based upon their own safety knowledge on a 4-point Likert scale ranging from "Strongly disagree" to "Strongly agree".

    At baseline and 1 and 3 months after the intervention

  • Changes from baseline safety behaviours at 3 months

    Child safety behaviours will be measured by different items adopted from the existing literature and questionnaires under the three contexts: home safety, road safety, and sports-related safety. Child participants will be asked to indicate their level of involvement in the said behaviour on a 5-point Likert scale ranging from "Never" to "Very Often", or their agreement on the given statement based upon their own safety knowledge on a 4-point Likert scale ranging from "Strongly disagree" to "Strongly agree".

    At baseline and 1 and 3 months after the intervention

Secondary Outcomes (4)

  • Changes from baseline child generic quality of life at 1 month

    At baseline and 1 and 3 months after the intervention

  • Changes from baseline child generic quality of life at 3 months

    At baseline and 1 and 3 months after the intervention

  • Changes from baseline children behaviours at 1 month

    At baseline and 1 and 3 months after the intervention

  • Changes from baseline children behaviours at 3 months

    At baseline and 1 and 3 months after the intervention

Study Arms (2)

Game intervention group

EXPERIMENTAL

Participants assigned to the intervention group will be given a manual containing instructions to play the Safe City game. A research assistant will provide a briefing session on the game in each participating school. A unique username and password set will be created for each user to log in the game. This login information will be provided to the student participants in a sealed envelope after the briefing session. The participants will be instructed to play the game as many times as desired within a 4-week time frame. The players ranked in the top 20 will receive a reward in the form of book coupon after the intervention ends.

Behavioral: Safe City game

Health education ("control") group

ACTIVE COMPARATOR

All students in the health education group will receive a comprehensive package on safety information. The information package includes both printed and electronic promotional materials regarding safety and a comprehensive list of relevant website and information sources. The information from these relevant websites and information sources are similar to those used in setting the safety case scenarios for the Safe City game. As a result, both intervention arms will have comparable accessibility to safety-related information and the major contrast between the two groups will be the method of presentation (game-based learning vs traditional health promotion approach, i.e. unidirectional information package).

Other: Health education

Interventions

Safe City gameBEHAVIORAL

The game intervention uses a game-based learning approach to teach players how to recognize and remove injury hazards from different homes and sports areas. It also highlights the need to pay attention to traffic and safety facilities to prevent injuries in a real-world environment. Players will create their own avatar to assume the duties of safety inspectors in the game. Point, level and reward systems will be included to increase player motivation to engage in the game.

Game intervention group

All students in the health education group will receive a comprehensive package on safety information. The information package includes both printed and electronic promotional materials regarding safety and a comprehensive list of relevant website and information sources. The information from these relevant websites and information sources are similar to those used in setting the safety case scenarios for the Safe City game. As a result, both intervention arms will have comparable accessibility to safety-related information and the major contrast between the two groups will be the method of presentation (game-based learning vs traditional health promotion approach, i.e. unidirectional information package).

Health education ("control") group

Eligibility Criteria

Age9 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Hong Kong Chinese children studying in Primary 4 to 6 Enrolling in non-special, local (non-international) primary schools in the 4 selected districts (Kwai Tsing, North, Sham Shui Po, and Tai Po)

You may not qualify if:

  • Non-Chinese speaking subjects. Non-consenting subjects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (2)

  • Wong RS, Tung KTS, Ho FKW, Wong WHS, Chow CB, Chan KL, Fu KW, Ip P. Effect of a Mobile Game-Based Intervention to Enhance Child Safety: Randomized Controlled Trial. J Med Internet Res. 2024 Feb 14;26:e51908. doi: 10.2196/51908.

  • Wong RS, Tung KT, Wong HT, Ho FK, Wong HS, Fu KW, Pong TC, Chan KL, Chow CB, Ip P. A Mobile Game (Safe City) Designed to Promote Children's Safety Knowledge and Behaviors: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jun 12;9(6):e17756. doi: 10.2196/17756.

MeSH Terms

Conditions

Wounds and InjuriesBehavior

Study Officials

  • Patrick Ip, MBBS, MPH

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 19, 2019

Study Start

September 1, 2020

Primary Completion

August 31, 2022

Study Completion

March 2, 2023

Last Updated

June 8, 2023

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations