- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03619473
Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program (MCHI)
Standard Motorcycle Child Safety Helmet Initiative Program for the Safety of Child Pillion Riders in Malaysia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Selangor
-
Hulu Langat, Selangor, Malaysia, 43000
- Recruiting
- Primary Schools in Hulu Langat District
-
Contact:
- Kulanthayan KC Mani
- Phone Number: +60 13-382 2000
- Email: kulan@upm.edu.my
-
Shah Alam, Selangor, Malaysia, 68000
- Recruiting
- Primary Schools in Petaling Perdana District
-
Contact:
- Kulanthayan KC Mani
- Phone Number: 0133822000
- Email: kulan@upm.edu.my
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Educational session followed by demonstration on
|
No Intervention: control
the group
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
|
|
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
|
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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