InjuriesNCT04096196
A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours
A study testing Safe City game and Health education in people with Injuries and Knowledge, Attitudes, Practice, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Injuries, Knowledge, Attitudes, Practice
- What is being tested?
- Safe City game and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Sep 2020to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- Non-Chinese speaking subjects. Non-consenting subjects.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safe City: a Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours
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.
Read the 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).
- Conditions
- Injuries, Knowledge, Attitudes, Practice
- Being tested
- Safe City game, Health education
- Medical subject headings
- Wounds and Injuries, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe City gameBehavioural
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.
Health educationOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: At baseline and 1 and 3 months after the intervention
Secondary outcomes (4)
Changes from baseline child generic quality of life at 1 month
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.
Measured: At baseline and 1 and 3 months after the intervention
Changes from baseline child generic quality of life at 3 months
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.
Measured: At baseline and 1 and 3 months after the intervention
Changes from baseline children behaviours at 1 month
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)
Measured: At baseline and 1 and 3 months after the intervention
Changes from baseline children behaviours at 3 months
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)
Measured: At baseline and 1 and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Sep 2020
- Primary completion31 Aug 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InjuriesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Ip, MBBS, MPH, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096196
- Sponsor's protocol ID
- SC2019HK
- Status last verified
- May 2022
- First submitted
- 13 Sep 2019
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38354042Wong 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.
PubMed 32530436
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe City: a Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours
- ClinicalTrials.gov ID
- NCT04096196
- Acronym / sponsor ID
- SC2019HK
- Conditions
- Injuries, Knowledge, Attitudes, Practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Game intervention group | Experimental | Behavioral: Safe City gameParticipants 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. |
| Health education ("control") group | Active comparator | Other: Health educationAll 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). |
Who may qualify
- Ages
- 9 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Non-Chinese speaking subjects. Non-consenting subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe City gameThe 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. | Behavioural | Game intervention group |
| Health educationAll 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 ("control") group |
Primary outcome
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".
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".
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".
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".
4 secondary outcomes
Changes from baseline child generic quality of life at 1 month
Time frame: 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
Changes from baseline children behaviours at 1 month
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Derived from this study: PubMed 38354042Wong 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.
- Derived from this study: PubMed 32530436Wong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Ip, MBBS, MPH principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe City game and Health education in people with Injuries and Knowledge, Attitudes, Practice, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline safety knowledge at 1 month (time frame: At baseline and 1 and 3 months after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04096196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.