Head InjuriesMCHINCT03619473
Standard Motorcycle Child Safety Helmet Initiative (MCHI) Program
A study testing Standard motorcycle child safety helmet in people with Head Injuries, run by Universiti Putra Malaysia at 2 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Injuries
- What is being tested?
- Standard motorcycle child safety helmet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesMalaysia
- Study dates
- 1 Jan 2016to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Students who are travelling to school using mode of transport other than motorcycle.
- pre school students
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites, 2 recruiting
- Recruiting
Primary Schools in Hulu Langat District
Hulu Langat, Selangor, 43000
Kulanthayan KC Mani, +60 13-382 2000, kulan@upm.edu.my
- Recruiting
Primary Schools in Petaling Perdana District
Shah Alam, Selangor, 68000
Kulanthayan KC Mani, 0133822000, kulan@upm.edu.my
About this study
Official title: 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.
Read the 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.
- Conditions
- Head Injuries
- Being tested
- Standard motorcycle child safety helmet
- Keywords
- standard motorcycle child safety helmet, chinstrap, toy/game helmet
- Medical subject headings
- Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard motorcycle child safety helmetBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | 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 Receives: Behavioral: Standard motorcycle child safety helmet |
| control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
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
Measured: 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
- 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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jan 2016
- Primary completion30 Nov 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Halliburton Foundation USA, Safe Kids Worldwide USA
- Responsible party
- Principal investigator, Assoc Prof Dr Kulanthayan K.C. Mani, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619473
- Sponsor's protocol ID
- Motorcycle Child Helmet Study
- Other IDs
- 6384400
- Acronym
- MCHI
- Status last verified
- Aug 2018
- First submitted
- 12 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 11072489
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Motorcycle Child Safety Helmet Initiative Program for the Safety of Child Pillion Riders in Malaysia
- ClinicalTrials.gov ID
- NCT03619473
- Acronym / sponsor ID
- MCHI / Motorcycle Child Helmet Study
- Conditions
- Head Injuries
- Keywords
- standard motorcycle child safety helmet, chinstrap, toy/game helmet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Collaborators
- Halliburton Foundation USA, Safe Kids Worldwide USA
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 Nov 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: Standard motorcycle child safety helmetthe 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 |
| control | No intervention | –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 |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Students who are travelling to school using mode of transport other than motorcycle.
- pre school students
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard motorcycle child safety helmetEducational 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 | Behavioural | intervention |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Background: PubMed 11072489Kulanthayan 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.
- safekids malaysia facebook pageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard motorcycle child safety helmet in people with Head Injuries, run by Universiti Putra Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03619473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.