Focus of Study: Bicycle Helmet Wearing CompliancePhase 1NCT01629121
Prevention of Traumatic Brain Injury in Youth and Adolescents
A Phase 1 study testing education intervention in people with Focus of Study: Bicycle Helmet Wearing Compliance, run by Augusta University at 1 site in United States.
Trial summary
The hypothesis was that the implementation of a Safe Kids East Central brain injury prevention program targeting children and caregivers admitted to the Georgia Health Sciences University Children's Medical Center is feasible and that short-term treatment effects of injury prevention education on the child or… Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Focus of Study: Bicycle Helmet Wearing Compliance
- What is being tested?
- education intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2011
- Phase
- Phase 1
- 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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Hospitalized in-patients in the Children's Medical Center;
- Projected length of stay >24 hours;
- Mentally and physically fit to complete the educational program;
- History of regular (>1x per week) bicycle riding;
- All racial/ethnic groups.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Regents University, Children's Medical Center
Augusta, Georgia, 30912
About this study
The hypothesis was that the implementation of a Safe Kids East Central brain injury prevention program targeting children and caregivers admitted to the Georgia Health Sciences University Children's Medical Center is feasible and that short-term treatment effects of injury prevention education on the child or adolescent and the caregiver will increase bicycle helmet use.
Read the detailed description
The overarching goal of this project is to reduce traumatic brain injury in children and adolescents by promoting bicycle helmet use via an inpatient educational program. The Safe Kids East Central injury prevention educational program was customized for hospitalized subjects and their caregivers. The investigators hypothesized that this program would increase bicycle helmet use.
- Being tested
- education intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education interventionBehavioural
The brain injury prevention education intervention included case scenarios as well as education about the benefits of bicycle helmet use. The intervention was designed to be sensitive to the age and educational level of the study participant and his or her parents. Educational materials were chosen to provide use of the five senses to enhance the learning experience. The intervention took place in the privacy of the patient's hospital room. The study was designed so as not to interfere with the hospital standard of care.
The proper way to fit the bicycle helmet was demonstrated.
| Study group | Role | What they receive |
|---|---|---|
| education intervention | Experimental | The intervention delivered education about the benefits of bicycle helmet use and safety and was designed to be sensitive to the age and educational level of the study participant. Receives: Behavioral: education intervention |
| control | No intervention | Printed materials were given to the control group, along with a helmet for each participant. |
What is being measured
The primary outcome is the main question the study is designed to answer.
parental report of bicycle helmet use
A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.
Measured: change for baseline in bicycle helmet wearing at 1 and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionAug 2011
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 Focus of Study: Bicycle Helmet Wearing ComplianceStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vernon Barnes, Augusta University
- Investigators
- Vernon A Barnes, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01629121
- Sponsor's protocol ID
- GHSF11085
- Status last verified
- Jun 2013
- First submitted
- 19 Jun 2012
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Barnes VA, Maria BL, Caldwell AL, Hopkins I. Prevention of Traumatic Brain Injury in Youth and Adolescents. J Child Neurol. 2013 Nov;28(11):1412-1417. doi: 10.1177/0883073812464272. Epub 2012 Nov 8.
PubMed 23143720
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Traumatic Brain Injury in Youth and Adolescents
- ClinicalTrials.gov ID
- NCT01629121
- Acronym / sponsor ID
- GHSF11085
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 27 Jun 2012 (estimated)
- 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 hypothesis was that the implementation of a Safe Kids East Central brain injury prevention program targeting children and caregivers admitted to the Georgia Health Sciences University Children's Medical Center is feasible and that short-term treatment effects of injury prevention education on the child or adolescent and the caregiver will increase bicycle helmet use.
Detailed description
The overarching goal of this project is to reduce traumatic brain injury in children and adolescents by promoting bicycle helmet use via an inpatient educational program. The Safe Kids East Central injury prevention educational program was customized for hospitalized subjects and their caregivers. The investigators hypothesized that this program would increase bicycle helmet use.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| education intervention | Experimental | Behavioral: education interventionThe intervention delivered education about the benefits of bicycle helmet use and safety and was designed to be sensitive to the age and educational level of the study participant. |
| control | No intervention | –Printed materials were given to the control group, along with a helmet for each participant. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Hospitalized in-patients in the Children's Medical Center;
- Projected length of stay >24 hours;
- Mentally and physically fit to complete the educational program;
- History of regular (>1x per week) bicycle riding;
- All racial/ethnic groups.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| education interventionThe brain injury prevention education intervention included case scenarios as well as education about the benefits of bicycle helmet use. The intervention was designed to be sensitive to the age and educational level of the study participant and his or her parents. Educational materials were chosen to provide use of the five senses to enhance the learning experience. The intervention took place in the privacy of the patient's hospital room. The study was designed so as not to interfere with the hospital standard of care. The proper way to fit the bicycle helmet was demonstrated. | Behavioural | education intervention |
Primary outcome
parental report of bicycle helmet use
Time frame: change for baseline in bicycle helmet wearing at 1 and 3 months
A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Results publication: PubMed 23143720Barnes VA, Maria BL, Caldwell AL, Hopkins I. Prevention of Traumatic Brain Injury in Youth and Adolescents. J Child Neurol. 2013 Nov;28(11):1412-1417. doi: 10.1177/0883073812464272. Epub 2012 Nov 8.
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.
Vernon A Barnes, PhD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing education intervention in people with Focus of Study: Bicycle Helmet Wearing Compliance, run by Augusta University at 1 site in United States.
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 5 inclusion and 0 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: finished, as of the sponsor's last update on 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parental report of bicycle helmet use (time frame: change for baseline in bicycle helmet wearing at 1 and 3 months). 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 NCT01629121, 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 21 Jun 2013.