There is a need for more pediatric clinical research to ensure that youth are receiving appropriate medications, treatments, and devices that have been tested with youth rather than adults. However, recruitment barriers exist for both youth and their parents including: not understanding the importance of clinical trials, fear of procedures, fear of the unknown in research, lack of knowledge about research procedures like informed consent and concerns around placebos, and worries about poor health outcomes. Adolescents are also more likely to be involved in the decision-making process along with their parents. Therefore, both adolescents and parents need resources to help them understand pediatric clinical research and procedures as well as to encourage high quality joint decision-making related to participation in research. This Fast Track application proposes to build upon the success of an earlier version of DigiKnowIt News (DKIN), a web-based resource to educate children (ages 8-11) about pediatric clinical research.
We aim to fill the gap in available resources for adolescents by creating DigiKnowIt News ? Teen (DKIN: Teen), a developmentally appropriate web-based resource for youth ages 12-17, which will include an innovative section for parents and youth to practice communicating and joint decision-making. It is hypothesized that by using the resource, adolescents will report an increase in their knowledge, positive attitudes/beliefs, self-efficacy, and willingness to participate in clinical trials. Phase I will include creating a developmentally appropriate version of DKIN for adolescents using an iterative development process with feedback from youth and parent advisory panels as well as expert consultants and a feasibility study of the resource with a sample of adolescents (N=30), who will complete self- report measures about their knowledge, attitudes, and self-efficacy, as well as consumer satisfaction questionnaire to provide feedback on the resource. If DKIN-Teen is feasible, Phase II will include the creation of additional content specific to common procedures in pediatric clinical trials (e.g., sedation/anesthesia) as well as to create additional customization abilities for researchers to use the DKIN resources for study recruitment. DKIN: Teen will be optimized for use on computers, mobile devices, and tablets, and tested for Section 508 compliance, thus increasing the accessibility and usability of the web-based resource. Finally, the effectiveness of DKIN: Teen will be evaluated with a diverse group (race/ethnicity/gender/health status) of parent-adolescent pairs (N=180) for impacting youths? knowledge, attitudes/beliefs, self-efficacy, and willingness as well as enhancing parent-adolescent communication related to participating in clinical trials. Current methods of pediatric clinical trials recruitment are haphazard, time-consuming, frustrating, inefficient, and often result in less than ideal sample size needed for statistical analysis. This highly scalable, customizable product will be designed to increase the number of adolescents who are willing to participate in clinical studies, which is needed to improve the treatments for pediatric illnesses and disorders.

Public Health Relevance

It is of upmost importance to ensure that medical procedures, devices, and treatments are tested in pediatric clinical trials to determine their efficacy for improving the health and well-being of youth; however, challenges with participant recruitment and retention (e.g., awareness, motivation, and anxiety) remains a major barrier to successful pediatric clinical trials. Thus, the goal of this Fast Track application is to develop and evaluate DigiKnowIt News: Teen, a web-based resource for youth (ages 12-17) to increase their knowledge, attitudes, self-efficacy, and willingness to participate. This product will have an impact on the field of pediatrics and clinical research by providing researchers with a web-based resource that can be easily customizable based on goals of a study or organization and assist with educating more adolescents about pediatric clinical research.

Agency
National Institute of Health (NIH)
Institute
National Institute of Nursing Research (NINR)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
4R44NR019565-02
Application #
10226693
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Bough, Kristopher J
Project Start
2020-03-19
Project End
2022-07-31
Budget Start
2020-09-16
Budget End
2021-07-31
Support Year
2
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Innovation Research and Training, Inc.
Department
Type
DUNS #
023317253
City
Durham
State
NC
Country
United States
Zip Code
27713