Clinical trial NCT03619473: Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program
Official title: Standard Motorcycle Child Safety Helmet Initiative Program for the Safety of Child Pillion Riders in Malaysia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head Injuries
Keywords: standard motorcycle child safety helmet
chinstrap
toy/game helmet
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Halliburton Foundation USA
name: Safe Kids Worldwide USA
First posted: 2018-08-08
Enrollment: 2000
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The main aim of this intervention study is to test the hypothesis if helmet initiative program will significantly increase helmet usage in primary school students. The secondary aim of this intervention is to evaluate the behavioral change in standard child safety helmet usage among the parent/adult riders. The study was conducted in 23 primary school in Selangor from 1st January 2016 to 31st December 2018 in three different phases.

Detailed description: In Malaysia, the road traffic plans estimated that the number of death on road traffics might increase almost 23% from 2014-2020 (Royal Police of Malaysia, 2017). The main road crash involved the motorcyclist and the main cause of death was due to the severe head injuries. Previous study in Malaysia had reported only 20% of proper helmet usage among the adult riders (Malaysian Institute of Road Safety Research, 2015). This highlights the need to transfer the knowledge to the parent/adult riders on the importance, proper usage and availability of the standard child safety helmet and hence increase the prevalence of standard helmet usage for the pillion riders especially for the children.

Eligibility criteria: Inclusion Criteria:

* primary school students from selected school
* aged 7 - 12 years old
* Travel to school by motorcycle.
* the adult rider able to speak/read Malay and English

Exclusion Criteria:

* Students who are travelling to school using mode of transport other than motorcycle.
* pre school students

Primary outcomes:
measure: There will be increase in the prevalence of standard motorcycle child safety helmet usage in post intervention compared to pre-intervention
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: There will be increase in the prevalence of proper standard motorcycle safety helmet usage in post intervention compared to pre-intervention
timeFrame: through study completion, an average of 1 year
measure: There will be increase in mean score of parents' knowledge measured using questionnaire in standard motorcycle child safety helmet usage in post intervention compared to pre-intervention
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Hulu Langat
country: Malaysia
facility: Primary Schools in Hulu Langat District
state: Selangor
city: Shah Alam
country: Malaysia
facility: Primary Schools in Petaling Perdana District
state: Selangor
Study officials:
References:
citation: Kulanthayan S, Umar RS, Hariza HA, Nasir MT, Harwant S. Compliance of proper safety helmet usage in motorcyclists. Med J Malaysia. 2000 Mar;55(1):40-4.