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

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ClinicalTrials.gov Identifier: NCT03619473
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Halliburton Foundation USA
Safe Kids Worldwide USA
Information provided by (Responsible Party):
Assoc Prof Dr Kulanthayan K.C. Mani, Universiti Putra Malaysia

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.

Condition or disease Intervention/treatment Phase
Head Injuries Behavioral: Standard motorcycle child safety helmet Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Standard Motorcycle Child Safety Helmet Initiative Program for the Safety of Child Pillion Riders in Malaysia
Actual Study Start Date : January 1, 2016
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : December 31, 2018

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


  2. 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



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619473


Locations
Malaysia
Primary Schools in Hulu Langat District Recruiting
Hulu Langat, Selangor, Malaysia, 43000
Contact: Kulanthayan KC Mani    +60 13-382 2000    kulan@upm.edu.my   
Primary Schools in Petaling Perdana District Recruiting
Shah Alam, Selangor, Malaysia, 68000
Contact: Kulanthayan KC Mani    0133822000    kulan@upm.edu.my   
Sponsors and Collaborators
Universiti Putra Malaysia
Halliburton Foundation USA
Safe Kids Worldwide USA

Additional Information:
Publications:
Responsible Party: Assoc Prof Dr Kulanthayan K.C. Mani, Executive Director, Universiti Putra Malaysia
ClinicalTrials.gov Identifier: NCT03619473     History of Changes
Other Study ID Numbers: Motorcycle Child Helmet Study
6384400 ( Other Grant/Funding Number: Halliburton Foundation USA )
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assoc Prof Dr Kulanthayan K.C. Mani, Universiti Putra Malaysia:
standard motorcycle child safety helmet
chinstrap
toy/game helmet

Additional relevant MeSH terms:
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries