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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04096196
Other study ID # SC2019HK
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date March 2, 2023

Study information

Verified date May 2022
Source The University of Hong Kong
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 340
Est. completion date March 2, 2023
Est. primary completion date August 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 13 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Safe City game
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.
Other:
Health education
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).

Locations

Country Name City State
Hong Kong The University of Hong Kong Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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 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. At baseline and 1 and 3 months after the intervention
Secondary 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. At baseline and 1 and 3 months after the intervention
Secondary 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) At baseline and 1 and 3 months after the intervention
Secondary 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) At baseline and 1 and 3 months after the intervention
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