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

August 1, 2018 updated by: Assoc Prof Dr Kulanthayan K.C. Mani, Universiti Putra Malaysia

Standard Motorcycle Child Safety Helmet Initiative Program for the Safety of Child Pillion Riders in Malaysia

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Selangor
      • Hulu Langat, Selangor, Malaysia, 43000
        • Recruiting
        • Primary Schools in Hulu Langat District
        • Contact:
      • Shah Alam, Selangor, Malaysia, 68000
        • Recruiting
        • Primary Schools in Petaling Perdana District
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention

the group

  1. assessed for proper helmet usage (type, chinstrap, standard helmet usage)
  2. evaluated for the behavioral of helmet usage
  3. underwent the educational session under helmet initiative program
  4. received one standard motorcycle child safety helmet per family
  5. assessed for proper helmet usage (type, chinstrap, standard helmet usage) 3 months after educational session and after received standard motorcycle child safety helmet
  6. evaluated for the behavioral of helmet usage 3 months after educational session and after received standard motorcycle child safety helmet
Behavioral: Standard motorcycle child safety helmet

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
No Intervention: control

the group

  1. assessed for proper helmet usage (type, chinstrap, standard helmet usage)
  2. evaluated for the behavioral of helmet usage
  3. 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
There will be increase in the prevalence of standard motorcycle child safety helmet usage in post intervention compared to pre-intervention
Time Frame: through study completion, an average of 1 year
  1. 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.
  2. 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
  3. 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
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
There will be increase in the prevalence of proper standard motorcycle safety helmet usage in post intervention compared to pre-intervention
Time Frame: through study completion, an average of 1 year

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
through study completion, an average of 1 year
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
Time Frame: through study completion, an average of 1 year
  1. The usage of standard child motorcycle helmet among child pillion riders will be more successful when they receive consistent messages from their parents.
  2. 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.
  3. parents' practice in helmet usage will significantly motivates the children to wear a helmet
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Collaborators

Safe Kids Worldwide USA
Halliburton Foundation USA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Anticipated)

November 30, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 8, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Motorcycle Child Helmet Study
  • 6384400 (Other Grant/Funding Number: Halliburton Foundation USA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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