Impact of Helmet Use in Preschool Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

609 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

* To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution;
* To test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Traumatic Brain Injury in Youth and Adolescents

NCT01629121

Focus of Study: Bicycle Helmet Wearing Compliance

COMPLETED PHASE1

Assisting Low-Income Families at Pediatric Well-Child Care Visits

NCT00397644

Low-income Children's Well-child Care Visit

COMPLETED NA

Initial Evaluation of the Cellie Coping Kit for Children With Injury

NCT03153696

Injuries

COMPLETED NA

The Healthy Child Development Program Study

NCT04622969

Child Behavior Child Health Child, Preschool +1 more

COMPLETED NA

Intervention to Improve Driving Practices Among High-Risk Teen Drivers

NCT04317664

Drive Recidivism Communication +1 more

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families.

The magnitude and seriousness of the injury problem in these children in the community could be high. Many injuries may occur that are not treated in emergency departments. Even the occurrence of a minor injury in the face is undesirable. These ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head Injuries Facial Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Helmet and helmet education

Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.

Group Type EXPERIMENTAL

Bicycle helmet from Bell Sports Inc.

Intervention Type OTHER

As described under the respective arm

Helmet education

Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.

Group Type ACTIVE_COMPARATOR

Bicycle helmet education only

Intervention Type OTHER

As described under the respective arm

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Bicycle helmet from Bell Sports Inc.

As described under the respective arm

Intervention Type OTHER

Bicycle helmet education only

As described under the respective arm

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bell bicycle helmets Bicycle helmet education

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program
* The child must possess a bicycle or a riding toy to ride
* The child's caregiver speaks English or Spanish

Exclusion Criteria

* Age less than two or greater than 5-year olds
* 3-5 year old children that do not own a bicycle or a riding toy to ride
* The child's caregiver does not speak English or Spanish.

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No