This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.
This cluster randomized controlled trial will evaluate a community-based bicycle safety education program with and without an in-person parent training component. The investigators will recruit 180 early adolescent bicyclists (ages 9 to 12) and a parent/guardian from local neighborhood centers after school and summer programs, where the investigators have conducted preliminary studies. Randomization into the three study groups will occur at the site-level. Adolescent bicycles in all study group sites will be equipped with Pedal Portal, an innovative bicycle-mounted GPS/video system developed by the research team to objectively observe bicycling risk exposure and behaviors while bicycling. System data will be coded to measure bicycling exposure (hours, miles traveled, routes) and the types and rates of safety-relevant events (near crashes, crashes), and safety-relevant behaviors (e.g., following traffic rules, scanning for traffic at intersections). This will be the first randomized trial to use GPS and video technology to evaluate the effectiveness of a youth bicycle safety intervention in changing behavior. The control group will not receive any bicycle safety education programming. Participants in the first intervention group (Bike Club) will receive a 12-hour bicycle safety education program. Participants in the second intervention group (Bike Club Plus) 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. The investigators' main hypotheses are that adolescents who receive the bicycle safety intervention will have increased safety behaviors (e.g., helmet use, hazard recognition), reduced errors (e.g., riding against traffic, swerving/wobbling), and increased knowledge, perceptions, and self-efficacy compared to the control group; and adolescents whose parent receives the parent training will have even greater improvements in study outcomes than those whose parents do not receive the training. If successful, approaches from this study could be widely implemented to improve adolescent bicycling safety.
A Cluster Randomized Trial to Improve Adolescent Bicycling Safety
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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Sponsor: Cara J. Hamann
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.