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Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program (MCHI)

Primary Purpose

Head Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Standard motorcycle child safety helmet
Sponsored by
Universiti Putra Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Head Injuries focused on measuring standard motorcycle child safety helmet, chinstrap, toy/game helmet

Eligibility Criteria

7 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Primary Schools in Hulu Langat DistrictRecruiting
  • Primary Schools in Petaling Perdana DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

the group assessed for proper helmet usage (type, chinstrap, standard helmet usage) evaluated for the behavioral of helmet usage underwent the educational session under helmet initiative program received one standard motorcycle child safety helmet per family assessed for proper helmet usage (type, chinstrap, standard helmet usage) 3 months after educational session and after received standard motorcycle child safety helmet evaluated for the behavioral of helmet usage 3 months after educational session and after received standard motorcycle child safety helmet

the group assessed for proper helmet usage (type, chinstrap, standard helmet usage) evaluated for the behavioral of helmet usage assessed for proper helmet usage after 3 months 4 evaluated for the behavioral of helmet usage after 3 months do not receive any educational session or standard motorcycle child safety helmet

Outcomes

Primary Outcome Measures

There will be increase in the prevalence of standard motorcycle child safety helmet usage in post intervention compared to pre-intervention
There will be increase in the prevalence of standard motorcycle child safety helmet usage among primary school students after the educational session under helmet initiative program as well as after the distribution of standard motorcycle child safety helmets. The educational session under helmet initiative program will provide important information about the risks of riding without standard helmet include the severity of injury to children. This will be an effective effort for continuous usage of standard helmet among child pillion riders Distribution of standard motorcycle child safety helmets will be able to increase the ownership of standard child helmet especially among those who; hence will increase the prevalence of standard motorcycle child safety helmet usage

Secondary Outcome Measures

There will be increase in the prevalence of proper standard motorcycle safety helmet usage in post intervention compared to pre-intervention
Wearing a properly fitted, safety-approved motorcycle helmet will able to reduce head injuries. The educational session under helmet initiative program will provide important information about the severity of injury to children due to improper helmet usage. This will be an effective effort to reduce the prevalence of head injuries among child pillion riders
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
The usage of standard child motorcycle helmet among child pillion riders will be more successful when they receive consistent messages from their parents. The educational session under helmet initiative program will provide important information on the law, proper usage, risk of non-usage and the consequences to the parents which further will develope a positive attitude toward helmet wearing for children. parents' practice in helmet usage will significantly motivates the children to wear a helmet

Full Information

First Posted
July 12, 2018
Last Updated
August 1, 2018
Sponsor
Universiti Putra Malaysia
Collaborators
Halliburton Foundation USA, Safe Kids Worldwide USA
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1. Study Identification

Unique Protocol Identification Number
NCT03619473
Brief Title
Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program
Acronym
MCHI
Official Title
Standard Motorcycle Child Safety Helmet Initiative Program for the Safety of Child Pillion Riders in Malaysia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universiti Putra Malaysia
Collaborators
Halliburton Foundation USA, Safe Kids Worldwide USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head Injuries
Keywords
standard motorcycle child safety helmet, chinstrap, toy/game helmet

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
the group assessed for proper helmet usage (type, chinstrap, standard helmet usage) evaluated for the behavioral of helmet usage underwent the educational session under helmet initiative program received one standard motorcycle child safety helmet per family assessed for proper helmet usage (type, chinstrap, standard helmet usage) 3 months after educational session and after received standard motorcycle child safety helmet evaluated for the behavioral of helmet usage 3 months after educational session and after received standard motorcycle child safety helmet
Arm Title
control
Arm Type
No Intervention
Arm Description
the group assessed for proper helmet usage (type, chinstrap, standard helmet usage) evaluated for the behavioral of helmet usage assessed for proper helmet usage after 3 months 4 evaluated for the behavioral of helmet usage after 3 months do not receive any educational session or standard motorcycle child safety helmet
Intervention Type
Behavioral
Intervention Name(s)
Standard motorcycle child safety helmet
Intervention Description
Educational session followed by demonstration on proper helmet wearing how to differentiate non-standard and standard helmets how to keep motorcycle safe using ABCD concept importance of wearing bright clothes police summon for not wearing helmets live demo on poor performance of non-standard helmet giving away standard motorcycle child safety helmets oath taking by parents and children distribution and placement of VEM on parents' motorcycles
Primary Outcome Measure Information:
Title
There will be increase in the prevalence of standard motorcycle child safety helmet usage in post intervention compared to pre-intervention
Description
There will be increase in the prevalence of standard motorcycle child safety helmet usage among primary school students after the educational session under helmet initiative program as well as after the distribution of standard motorcycle child safety helmets. The educational session under helmet initiative program will provide important information about the risks of riding without standard helmet include the severity of injury to children. This will be an effective effort for continuous usage of standard helmet among child pillion riders Distribution of standard motorcycle child safety helmets will be able to increase the ownership of standard child helmet especially among those who; hence will increase the prevalence of standard motorcycle child safety helmet usage
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
There will be increase in the prevalence of proper standard motorcycle safety helmet usage in post intervention compared to pre-intervention
Description
Wearing a properly fitted, safety-approved motorcycle helmet will able to reduce head injuries. The educational session under helmet initiative program will provide important information about the severity of injury to children due to improper helmet usage. This will be an effective effort to reduce the prevalence of head injuries among child pillion riders
Time Frame
through study completion, an average of 1 year
Title
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
Description
The usage of standard child motorcycle helmet among child pillion riders will be more successful when they receive consistent messages from their parents. The educational session under helmet initiative program will provide important information on the law, proper usage, risk of non-usage and the consequences to the parents which further will develope a positive attitude toward helmet wearing for children. parents' practice in helmet usage will significantly motivates the children to wear a helmet
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Primary Schools in Hulu Langat District
City
Hulu Langat
State/Province
Selangor
ZIP/Postal Code
43000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kulanthayan KC Mani
Phone
+60 13-382 2000
Email
kulan@upm.edu.my
Facility Name
Primary Schools in Petaling Perdana District
City
Shah Alam
State/Province
Selangor
ZIP/Postal Code
68000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kulanthayan KC Mani
Phone
0133822000
Email
kulan@upm.edu.my

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11072489
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.
Results Reference
background
Links:
URL
https://www.facebook.com/safekidsmalaysia/
Description
safekids malaysia facebook page

Learn more about this trial

Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program

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