Dr. Alison Parker and Dr. Tracy Scull (Co-Principal Investigators) at Innovation Research & Training (IRT) were recently awarded a Phase II Small Business Innovation Research (SBIR) contract from the National Heart, Lung, and Blood Institute (NHLBI) to develop an interactive, web application for youth, called DigiKnowit News, with the goal of increasing the rates of youth participation in pediatric clinical trials. There is currently a need for more youth to participate in clinical trials in order to improve the quality and quantity of knowledge related to the health and well-being of children and adolescents. More research is necessary, so that youth are not provided with drugs or treatment recommendations that are based upon clinical research findings from studies conducted with adults. Given that youth are developmentally and physiologically different from adults, they may respond differently to treatment, and require different medications and dosages.

There are a number of barriers that may prevent youth from participating in pediatric clinical trials, such as parents’ needing to take time off from work, students needing to take time off from school, travel expenses, and children’s procedure-related anxiety.  The goal of the web-based resource is to provide information about pediatric clinical research to youth and their caregivers in order to educate them about the potential benefits of participation as well as to address their concerns.

DigiKnowIt News was initially developed as a prototype as part of a successful Phase I SBIR contract from NHLBI.  The interactivity and content of the web application was created with input and feedback from youth, parents, and experts in the fields of pediatric clinical research, child development, and instructional design. “This resource addresses the need to inform and educate youth in a fun and interactive way, and also, provides them with tools to facilitate their decision-making related to agreeing to participate in research,” said Dr. Parker.

A randomized controlled trial will be conducted to evaluate the efficacy of the web application for increasing the knowledge, self-efficacy, and positive attitudes related to participating in a pediatric clinical trial of children and adolescents. At the conclusion of this project, the web application will be available to any youth through a link on the NHLBI Children and Clinical Studies website The Kids Files.  In addition, iRT will prepare a commercially available version that will allow for the inclusion of branding and customizable content, so it can be tailored to a particular research study or organization.  iRT is currently refining the original prototype of the web application.  “We look forward to getting valuable input from youth and researchers who have been involved in pediatric clinical trials in order to integrate their perspectives into this needed resource,” said Dr. Scull.

About innovation Research & Training

innovation Research & Training (iRT) is a behavioral sciences research company committed to identifying and solving significant real-world problems facing children, families, communities, and organizations. By applying scientific theories, findings, and methods, iRT researchers develop and evaluate behavioral, educational, psychological, social, and community assessment, prevention, and treatment programs and services. Its staff includes experts in basic and applied psychology in the areas of substance abuse prevention and treatment, mentoring, social and emotional learning, mindfulness education, media literacy education, pregnancy prevention and sexual health promotion, violence and bullying prevention, child and adolescent mental health, and adult and juvenile justice programs. For more information about iRT, visit www.irtinc.us.

This project has been funded in whole or in part with Federal funds from the National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN268201700010C.