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Bicycle Safety Education for Adolescent Bicycling Safety
N/A
Recruiting
Led By Cara Hamann, PHD
Research Sponsored by Cara J. Hamann
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
9 to 12 years old
Fluency in English for the adolescent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within a six month period
Awards & highlights
Study Summary
This trial will evaluate a community-based bicycle safety education program with and without an in-person parent training component to see if it changes behavior.
Who is the study for?
This trial is for English-speaking adolescents aged 9 to 12 who have their own bicycle and ride at least twice a week. They must not have been in similar bike safety programs before, live in Johnson County, Iowa, and be willing to join after school or summer bicycling safety sessions. Only one child per family can participate, excluding wards of the state or those with conditions that make cycling unsafe.Check my eligibility
What is being tested?
The study tests a community-based bicycle safety education program (Bike Club) against an enhanced version with parent training (Bike Club Plus), compared to no intervention. Adolescents' bikes will be fitted with GPS/video tech (Pedal Portal) to track behavior and risk exposure while biking.See study design
What are the potential side effects?
There are no medical side effects as this is an educational intervention; however, participants may experience increased awareness of bicycling risks which could affect their confidence or stress levels temporarily.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 9 and 12 years old.
Select...
I am a teenager who speaks and understands English well.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ two weeks of data collection within a six-month period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two weeks of data collection within a six-month period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of positive and negative behaviors relative to the overall number of instances of a given event behavior
Rate of safety behaviors per 100 miles/minutes ridden
Rate of safety-relevant events per 100 miles/minutes ridden
Secondary outcome measures
Difference in identification and recall of Cues to Action
Difference in knowledge tests scores
Difference in mean ratings of perceptions
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Bike Club PlusExperimental Treatment1 Intervention
Participants will receive an enhanced version of the 12-hour bicycle safety education program which will include a parent training session on bicycling safety best practices, child development as it relates to bicycling, strategies for practice at home, and feedback on their adolescent's bicycling performance.
Group II: Bike ClubExperimental Treatment1 Intervention
Participants will receive a 12-hour bicycle safety education program
Group III: Control GroupActive Control1 Intervention
The control group will not receive any bicycle safety education programming.
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,963 Previous Clinical Trials
2,674,561 Total Patients Enrolled
1 Trials studying Knowledge
856 Patients Enrolled for Knowledge
Cara J. HamannLead Sponsor
Cara Hamann, PHDPrincipal InvestigatorUniversity of Iowa College of Public Health; University of Iowa Injury Prevention Research Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Only one adolescent will be enrolled in the study.\nI am between 9 and 12 years old.I ride a bike on my own at least twice a week.I have a health condition that makes physical activities like biking unsafe.I am a teenager who speaks and understands English well.I ride a bike on my own at least twice a week.I, or one of my parents/guardians, can fluently speak English, French, or Spanish.I am between 9 and 12 years old.You are willing to attend a bike safety session offered by NCJC after school or during the summer program.
Research Study Groups:
This trial has the following groups:- Group 1: Bike Club
- Group 2: Bike Club Plus
- Group 3: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies in this research trial for participants?
"Clinicaltrials.gov reveals that this medical study, first posted on May 31st 2022, is no longer actively recruiting patients. However, there are currently 141 other trials which remain open for enrolment."
Answered by AI
What sort of qualifications must be met to partake in this clinical research?
"This research is seeking 180 minors aged between 9 and 12 with some basic familiarity of the subject matter."
Answered by AI
Does this research study accept seniors as participants?
"The focus of this research is to enroll subjects aged between 9 and 12 years old."
Answered by AI
What are the aims of this research project?
"The primary outcome of this clinical trial, which will be tracked and analysed over a 6 month period with bi-weekly data collection sessions, is the rate of safety behaviours per 100 miles/minutes ridden. Additionally, secondary outcomes include patient's ratings on Likert Scales assessing perceptions pre and post treatment (higher scores indicating better results), knowledge test scores measured in the same manner as above, and recognition or recollection of Cues to Action through either yes/no responses or multiple choice questions."
Answered by AI
Who else is applying?
What state do they live in?
Iowa
How old are they?
< 18
What site did they apply to?
University of Iowa
What portion of applicants met pre-screening criteria?
Did not meet criteria
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