Pediatric clinical trials allow for the testing of appropriate and effective treatments for children. However, some challenges exist with recruitment. This study examined the effectiveness of DigiKnowIt News, an interactive, multimedia website (which includes activities, videos, and comic books) designed to educate children about clinical trials. A randomized controlled trial was conducted in 2018 with 91 participants ( M age = 10.92 years; SD = 2.06). Participants were randomly assigned to intervention or wait-list control groups and completed questionnaires at pretest and posttest (1 week later) about their knowledge, attitudes, beliefs about clinical trials, and self-efficacy for participating in clinical trials. Participants in the intervention group received access to DigiKnowIt News between pretest and posttest and completed a satisfaction questionnaire at posttest. At the end of the study, participants in the wait-list control group were offered the option to use the website and complete a satisfaction questionnaire. At posttest, participants in the intervention group, compared to participants in the wait-list control group, had more knowledge about clinical trials and more reported confidence for participating in clinical trials. Participants reported high levels of satisfaction with DigiKnowIt News. The findings suggest that an educational website can improve factors related to increasing rates of participation in clinical trials.

Background Pediatric research is crucial for the development of new scientific advancements, treatments, and therapies for adolescents. Yet relatively few pediatric clinical trials are conducted due to barriers to successful recruitment and retention, including knowledge and attitudes about clinical trials. Adolescents tend to experience greater autonomy to make decisions and have expressed interest in being part of the decision to participate in clinical trials. Increasing knowledge, positive attitudes, and self-efficacy related to clinical trials could positively impact the decision to participate in a pediatric clinical trial. However, there are currently few interactive, developmentally appropriate, web-based resources available to educate adolescents about clinical trials. DigiKnowItNews: Teen was created as a multimedia educational website to address the relatively low levels of enrollment in pediatric clinical trials and need for information to empower adolescents to make decisions about participating in clinical trials. Methods This is a parallel group randomized controlled superiority trial to test the effectiveness of DigiKnowItNews: Teen, for improving factors related to clinical trial participation among adolescent and parents. Eligible parent-adolescent (ages 12 to 17 years) pairs will be randomly assigned to one of two conditions: intervention or wait-list control. All participants will complete pre- and post-test questionnaires and participants assigned to the intervention will receive access to review the DigiKnowItNews: Teen content for 1 week. Wait-list control participants will have the option to review DigiKnowItNews: Teen after study completion. The primary outcomes are knowledge about clinical research, attitudes, and beliefs toward pediatric clinical trials, self-efficacy for making decisions related to clinical trial participation, willingness to participate in a future clinical trial, procedural fears, and parent-adolescent communication quality. Overall feedback and satisfaction related to DigiKnowItNews: Teen will also be collected. Discussion The trial will evaluate the effectiveness of DigiKnowIt News: Teen, an educational website about pediatric clinical trials for adolescents. If found effective in promoting factors related to future pediatric clinical trial participation, DigiKnowIt News: Teen could be used by adolescents, along with their parents, as they make the decision to participate in a clinical trial. Clinical trial researchers can also use DigiKnowIt News: Teen to aid their participant recruitment efforts. Trial registration ClinicalTrials.gov NCT05714943. Registered on 02/03/2023.