Clinical trial NCT04096196: A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours
Official title: Safe City: a Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injuries
Knowledge, Attitudes, Practice
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2019-09-19
Enrollment: 340
Sex: ALL
Minimum age (years): 9
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from baseline safety knowledge at 1 month
timeFrame: At baseline and 1 and 3 months after the intervention
measure: Changes from baseline safety knowledge at 3 months
timeFrame: At baseline and 1 and 3 months after the intervention
measure: Changes from baseline safety behaviours at 1 month
timeFrame: At baseline and 1 and 3 months after the intervention
measure: Changes from baseline safety behaviours at 3 months
timeFrame: At baseline and 1 and 3 months after the intervention
Secondary outcomes:
measure: Changes from baseline child generic quality of life at 1 month
timeFrame: At baseline and 1 and 3 months after the intervention
measure: Changes from baseline child generic quality of life at 3 months
timeFrame: At baseline and 1 and 3 months after the intervention
measure: Changes from baseline children behaviours at 1 month
timeFrame: At baseline and 1 and 3 months after the intervention
measure: Changes from baseline children behaviours at 3 months
timeFrame: At baseline and 1 and 3 months after the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Patrick Ip, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.