Abstract
BackgroundPoor clinical trial enrollment continues to be pervasive and is especially problematic among young adults and youth, and among minorities. Efforts to address barriers to enrollment have been predominantly focused on adult diseased populations. Because older adults may already have established attitudes, it is imperative to identify strategies that target adolescents and young adults. The purpose of this study was to test the effectiveness of an educational video on factors related to clinical trial participation among a healthy adolescent and young adult population.MethodsParticipants completed a 49-item pre-test, viewed a 10-min video, and completed a 45-item post-test to assess changes in attitudes, knowledge, self-efficacy, receptivity to, and intention to participate (primary outcome) in clinical trials. Descriptive statistics, paired samples t-tests, and Wilcoxon signed-rank tests were conducted.ResultsThe final analyses included 935 participants. The mean age was 20.7 years, with almost 70% aged 18 to 20 years. The majority were female (73%), non-Hispanic (92.2%), white (70%), or African American (20%). Participants indicated a higher intention to participate in a clinical trial (p < 0.0001) and receptivity to hearing more about a clinical trial (p < 0.0001) after seeing the video. Intention to participate (definitely yes and probably yes) increased by an absolute 18% (95% confidence interval 15–22%). There were significant improvements in attitudes, knowledge, and self-efficacy scores for all participants (p < 0.0001).ConclusionsThe results of this study showed strong evidence for the effectiveness of a brief intervention on factors related to participation in clinical trials. This supports the use of a brief intervention, in a traditional educational setting, to impact the immediate attitudes, knowledge, self-efficacy, and intention to participate in clinical trial research among diverse, healthy adolescents and young adults.
Highlights
Poor clinical trial enrollment continues to be pervasive and is especially problematic among young adults and youth, and among minorities
The impact of the intervention on the primary outcome was evidenced by significant increases in intention to participate in clinical trial research in general, and indirectly supported by the significant increase in intent to participate in the specific trial described in the hypothetical scenario
Research has demonstrated that brief educational efforts can impact attitudes and willingness to participate in clinical trial research [22, 27]
Summary
Poor clinical trial enrollment continues to be pervasive and is especially problematic among young adults and youth, and among minorities. Because older adults may already have established attitudes, it is imperative to identify strategies that target adolescents and young adults. The purpose of this study was to test the effectiveness of an educational video on factors related to clinical trial participation among a healthy adolescent and young adult population. Because reaching adults with broadly disseminated educational and behavioral interventions about clinical trials has practical limitations, and because some adults may already have established attitudes including longstanding distrust of the medical system [11], it is imperative to identify effective strategies that target adolescents and young adults. Child development and educational psychology research has consistently found that attitudes formed during adolescence persist into adulthood [12,13,14] and influence subsequent adult behavior, including health behaviors such as diet and exercise [14,15,16]. Irrespective of level of education, patients offered enrollment into trials struggle with the concept of randomized controlled trials, which suggests that general education of the public about trials is needed [17]
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