- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04096196
A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours
Safe City: a Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
To evaluate the effectiveness of the Safe City game, a randomized controlled trial (RCT) following the CONSORT RCT guidelines will be conducted.The evaluation will therefore be conducted in four school districts. An invitation will be sent to each selected school. After the school principal agrees to join the trial, informed written consents will be obtained from parents of the participating students by our research staff before randomization. The participant recruitment and randomization process will be independently carried out by different research assistants. Outcome assessors will be blinded to the allocation of participants in each group.
All consenting student participants, before intervention, will be asked to complete a questionnaire on basic socio-demographics. The intervention will last 4 weeks. Their safety knowledge and behaviours, HRQOL and psychosocial difficulties will be assessed before and 1 and 3 months after the intervention.
Game ("intervention") group The Safe City 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.
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 timeframe. The players ranked in the top 20 will receive a reward in the form of book coupon after the intervention ends.
Health education ("control") 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- The University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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)
Exclusion Criteria:
Non-Chinese speaking subjects. Non-consenting subjects.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Game intervention group
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.
|
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.
|
Active Comparator: Health education ("control") 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).
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline safety knowledge at 1 month
Time Frame: At baseline and 1 and 3 months after the intervention
|
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
Time Frame: At baseline and 1 and 3 months after the intervention
|
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
Time Frame: At baseline and 1 and 3 months after the intervention
|
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
Time Frame: At baseline and 1 and 3 months after the intervention
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline child generic quality of life at 1 month
Time Frame: At baseline and 1 and 3 months after the intervention
|
Child generic quality of life will be measured by the Chinese version of the PedsQL Generic Core Scales (Child-Self Report version) which has four subscales with a total of 23 items measuring the physical, emotional, social, and school functioning of the children.
Each item is rated on a 5-point scale from 0=never to 4=almost always.
A higher score indicates better functioning.
|
At baseline and 1 and 3 months after the intervention
|
Changes from baseline child generic quality of life at 3 months
Time Frame: At baseline and 1 and 3 months after the intervention
|
Child generic quality of life will be measured by the Chinese version of the PedsQL Generic Core Scales (Child-Self Report version) which has four subscales with a total of 23 items measuring the physical, emotional, social, and school functioning of the children.
Each item is rated on a 5-point scale from 0=never to 4=almost always.
A higher score indicates better functioning.
|
At baseline and 1 and 3 months after the intervention
|
Changes from baseline children behaviours at 1 month
Time Frame: At baseline and 1 and 3 months after the intervention
|
Strength and Difficulties Questionnaire (SDQ) will be used to measure children's behaviour.
The SDQ has five subscales, including emotional symptoms, conduct problems, peer relationship problems, hyperactivity/inattention, and prosocial behaviour.
Each subscale has a score, and the first four subscales generate a total score of difficulties (20 items)
|
At baseline and 1 and 3 months after the intervention
|
Changes from baseline children behaviours at 3 months
Time Frame: At baseline and 1 and 3 months after the intervention
|
Strength and Difficulties Questionnaire (SDQ) will be used to measure children's behaviour.
The SDQ has five subscales, including emotional symptoms, conduct problems, peer relationship problems, hyperactivity/inattention, and prosocial behaviour.
Each subscale has a score, and the first four subscales generate a total score of difficulties (20 items)
|
At baseline and 1 and 3 months after the intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Patrick IP, MBBS, MPH, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SC2019HK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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