NCT03619473

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

August 8, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

2.9 years

First QC Date

July 12, 2018

Last Update Submit

August 1, 2018

Conditions

Keywords

standard motorcycle child safety helmetchinstraptoy/game helmet

Outcome Measures

Primary Outcomes (1)

  • There will be increase in the prevalence of standard motorcycle child safety helmet usage in post intervention compared to pre-intervention

    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 Outcomes (2)

  • There will be increase in the prevalence of proper standard motorcycle safety helmet usage in post intervention compared to pre-intervention

    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

    through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

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

intervention

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Students who are travelling to school using mode of transport other than motorcycle.
  • pre school students

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Primary Schools in Hulu Langat District

Hulu Langat, Selangor, 43000, Malaysia

RECRUITING

Primary Schools in Petaling Perdana District

Shah Alam, Selangor, 68000, Malaysia

RECRUITING

Related Publications (1)

  • 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.

    PMID: 11072489BACKGROUND

Related Links

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

July 12, 2018

First Posted

August 8, 2018

Study Start

January 1, 2016

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

August 8, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations