Most materials used to educate children and adolescents about clinical trials do not account for their developmental abilities and interests. When children receive information about your clinical trial that is neither interesting nor understandable to them, they may feel confused or apprehensive about participating in your study, which could negatively impact your participation rates.

DigiKnowIt News includes various types of educational experiences that are designed to appeal to children with different learning styles, developmental abilities, and interests, so they can choose how they want to learn about research and your study. By communicating with children about research in unique, developmentally-appropriate ways, DigiKnowIt News helps children feel more confident and prepared to decide about whether to participate in your study.

For example, DigiKnowIt News is one of the first websites about clinical trials designed specifically for children and it is also one of the only websites we have located that contains a library of videotaped interviews with young people who have been a participant in a clinical trial. This educational strategy accounts for the fact that children and adults seek out the advice of peers when making a wide range of life decisions. In fact, children have reported that they would prefer to hear from peers, rather than adults, about their experiences participating in a clinical trial.¹

The DigiKnowIt News team applied these basic research findings to designing the building blocks of the website by creating a series of videotaped interviews, called “Spotlights,” with children and adolescents about their experiences being a participant in a clinical trial.  In this way, children could hear from their peers, who may serve as role models regarding participation in a clinical trial. Some potential participants may view similar-aged peers as more trustworthy sources of information about clinical trials than other sources who might have not been in a clinical trial before. In addition, the Spotlights include a diverse group of youth including children and adolescents, boys and girls, and children who vary in terms of their race and ethnicity, so that youth can personally relate to the people in the videos.

Youth discuss a variety of topics in the videos including why they decided to participate in a clinical trial, how they knew the clinical trial would be safe, what kinds of questions they suggest asking before participating in a trial, how they stayed calm whenever they became nervous during their participation, and more. These perspectives from young people go beyond just educating youth on basic information about clinical trials to empowering youth and helping them feel confident when making a decision about whether or not to assent to participate. During the development of DigiKnowIt News, youth who had previously participated in a clinical trial reported on what information they would have liked to have known prior to participating, so that the DigiKnowIt News team could incorporate as much beneficial information for youth as possible into the questions and answers in the videotaped interviews.

A main goal in the development of DigiKnowIt News was to create an informational resource that would appeal to a wide array of youth with different learning styles and developmental abilities, so that DigiKnowIt News would be effective for use with a diverse group of children and adolescents.

If you would like to start using DigiKnowIt News to educate children about research, so they may feel more comfortable and confident when making the decision to participate in your study, click here to get started.

1. Martin-Kerry JM, Knapp P, Atkin K, et al. (2019) Supporting children and young people when making decisions about joining clinical trials: Qualitative study to inform multimedia website development. BMJ Open 9: e023984

Are you struggling to recruit children or adolescents for your research? Are you concerned that you may face high attrition rates in your upcoming study with youth? If so, you are not alone. Many researchers find recruiting and retaining young participants in their studies challenging.

The DigiKnowIt News website is designed to help researchers recruit and retain more children and adolescents in research studies by empowering and involving young people in the decision-making process about whether to participate or not.

Why should involving children and adolescents in the decision-making process be a priority for you?

Many young people are interested in learning about clinical trials and opportunities to participate in a clinical trial.¹ In addition, young people and their parents report that they value the inclusion of the young person in the decision-making process about whether or not to participate in a clinical trial.² Family dynamics can affect how engaged a child is in the decision-making process; some parents might make the final decision and some parents might involve their children in the decision.

When a child or adolescent understands that they have a voice in the decision-making process, they may feel more confident assenting to participate and more motivated to take part in a study. Feeling empowered during the decision-making process may also lead a young person to feel comfortable speaking up and asking questions when they are actively participating in a clinical trial, which may make them less likely to end their participation early if they become uncomfortable or confused at any point during the trial.

By prioritizing the empowerment and inclusion of youth in the process of making a decision to participate in your clinical trial, you may increase the likelihood of collaborative decision-making among parents and their children, help young people feel motivated to participate, and prevent attrition in your study.

How can DigiKnowIt News help you empower children and adolescents during the decision-making process?

DigiKnowIt News was strategically designed to empower young people during the decision-making process by providing them with important information about clinical trials, illustrating what participation in a trial may be like, and offering them opportunities to practice making decisions related to clinical trials. Children and adolescents can better contribute to making a decision about their participation when they fully understand what a clinical trial is and what they are being asked to do. Knowledge about clinical trials and the decision-making process may also help children and adolescents feel more comfortable and confident when making a decision about their participation.

To empower young people, DigiKnowIt News includes videotaped, hypothetical situations related to pediatric clinical trials in which they can use their decision-making skills and reinforce the knowledge learned in the website. DigiKnowIt News also describes what participant rights are and how young people can learn about their rights in the clinical trial they are considering participating in. DigiKnowIt News encourages children and adolescents to use their voice before and during their participation in a clinical trial by describing the importance of them asking questions and having discussions with their parents, research team members, and medical professionals.

DigiKnowIt News also contains an eLearning module dedicated to teaching adolescents and their parents what the shared decision-making process may involve. The module is designed to promote healthy communication and collaboration between adolescents and their parents during the decision-making process, while empowering teens to contribute to decision-making instead of simply accepting their parents’ decisions.

Incorporating the voices and feedback of children and adolescents was a priority for our research team as we developed DigiKnowIt News. Our team gathered insights and feedback from youth and parent advisory panels as well as from parent-youth pairs to ensure that its content was relevant, engaging, and developmentally appropriate for children and adolescents. Our team also conducted two randomized controlled trials which found that children and adolescents in the intervention groups (who viewed DigiKnowIt News) reported being significantly more confident in their abilities to participate in a clinical trial and more positive about participating in a clinical trial than youth in the active control group (who viewed an alternative website).^3,4

The perspectives of children and adolescents have helped our team develop DigiKnowIt News in ways that are empowering to young people, so that researchers like yourself now have a readily available tool to use to involve children and adolescents in the clinical trials decision-making process to increase participation and lower attrition rates in their studies.

1. Luchtenberg, M., Maeckelberghe, E., Locock, L., Powell, L., & Verhagen, A. A. (2015). Young People’s Experiences of Participation in Clinical Trials: Reasons for Taking Part. American Journal of Bioethics, 15(11), 3-13. https://doi.org/10.1080/15265161.2015.1088974
2. Ingersgaard, M. V., Tulstrup, M., Schmiegelow, K., & Larsen, H. B. (2018). A qualitative study of decision-making on Phase III randomized clinical trial participation in paediatric oncology: Adolescents’ and parents’ perspectives and preferences. Journal of Advanced Nursing, 74(1), 110-118. https://doi.org/10.1111/jan.13407
3. Parker, A. E., Scull, T. M., & Morrison, A. M. (2022). DigiKnowIt News: Educating youth about pediatric clinical trials using an interactive, multimedia educational website. Journal of Child Health Care, 26(1), 139-153.
4. Parker, A. E., Scull, T. M., Green, J., & Stump, K. (in press). Evaluation of an interactive, educational website developed for adolescents to learn about pediatric clinical trials: DigiKnowIt News.

To feel informed and comfortable to decide to participate in your research study and to complete the study protocol, children and adolescents must be provided with opportunities to ask questions about your study and what their participation may involve. Like most researchers, you probably provide these types of opportunities to all prospective volunteers as well as all of the enrolled participants all throughout your study protocol. However, research has revealed that despite these efforts, some young people still may not actually know what types of questions they should ask that will provide answers to address their fears, motivate them to participate, and explain the study activities to them in ways that enhance their comprehension.¹

DigiKnowIt News addresses these needs to help you recruit and retain more young people for your research.

Why is it important for your prospective participants to ask questions?

As discussed in a previous blog, the most common reasons young people are reluctant to participate in research studies are that they:

1. are afraid of the risks involved with participation and
2. have been misinformed or are uninformed about research.

Helping children and adolescents understand the benefits and risks, and develop realistic expectations related to research participation may help them feel more motivated and confident about participating in your study.

A vital part of helping young people understand these concepts is providing them with opportunities to ask questions about your research.

When young people ask questions, researchers, parents, and healthcare providers also have opportunities to address potential participants’ fears about research, so they may be less reluctant to participate.

In addition, being given opportunities to ask questions during the assenting process may empower children and help them feel more confident in their abilities to make a decision about participating in a study.²

How can you help children understand what questions to ask, so they may better understand your specific research project and feel more comfortable about participating?

You can design DigiKnowIt News to reflect your study’s methods and procedures, and offer access to the website to prospective participants.

DigiKnowIt News provides children and adolescents with information about:

1. what clinical trials are,
2. what they may expect from participation in a clinical trial and/or in your study,
3. benefits and risks associated with participation in a clinical trial and/or in your study,
4. their rights as a participant,
5. the importance of asking questions before and during research participation,
6. what types of questions might be helpful to ask about your study, and
7. who they can question about different topics related to your study.

By developing a basic understanding of these concepts, young people are better able to formulate their own questions about research participation, so they can expand their knowledge and build their motivations to participate.

DigiKnowIt News contains various activities designed to teach young people how to ask questions before or during a study, as well as examples of questions they can ask. For example:

• Youth can participate in a simulated “interview” with a researcher as part of an interactive learning module. Youth can select what questions they would like to ask the researcher from a list of common questions that participants have about research and then, receive answers from the researcher in brief video responses.
• As part of another interactive learning module, youth can practice asking questions and speaking in a simulated “conversation” with their character’s parents as their character makes a decision about whether or not to participate in a clinical trial.
• Youth can read and interact with digital comic books that show demonstrations of a character asking questions and having discussions with their doctor, parents, and research staff.
• Children and adolescents can view video interviews, called Spotlights, of youth sharing their real-life experiences participating in a clinical trial, including the kinds of questions they asked when they decided to participate.

It is important that your research team not only encourages children and adolescents to ask questions about your research study during the assenting process, but also help young people to understand who and how to ask questions. DigiKnowIt News teaches young people basic knowledge about clinical trials and the skills they need to formulate and ask questions based on their fears and curiosities about participation. In turn, your research team will be able to provide answers to potential participants that ease their fears about research, help them understand what they will do as part of your study, and form realistic expectations for participation, which will ultimately help them to feel more motivated to participate.

1. Lambert, V., & Glacken, M. (2011). Engaging with children in research: Theoretical and practical implications of negotiating informed consent/assent. Nursing ethics, 18(6), 781–801. https://doi.org/10.1177/0969733011401122
2. Miller, V. A., Feudtner, C., & Jawad, A. F. (2017). Children’s Decision-Making Involvement About Research Participation: Associations With Perceived Fairness and Self-Efficacy. Journal of empirical research on human research ethics : JERHRE, 12(2), 87–96. https://doi.org/10.1177/1556264617696921

Educating children and adolescents about your research study’s protocols and procedures may help them feel more comfortable and prepared to participate in your research. However, information that is commonly shared during and after the assenting process is typically written by adults, lengthy, and difficult to read. That means that the information used to educate young people about research may not be easy for them understand, which could make them feel unsure or uncomfortable about making the decision to participate in a study.

DigiKnowIt News fills this gap in readily available tools for researchers to use with youth, because it is both developmentally appropriate and engaging. The DigiKnowIt News website was developed with the developmental abilities, interests, and needs of children and teenagers in mind, so that it would pique their interest by being interactive, visually compelling, and relevant. The goal of creating this customizable website was to engage youth enough so they would be motivated to learn about research. In order to accomplish these goals, both children and teenagers assisted with the development of DigiKnowIt News and shared their preferences about how the preferred to learn.

Are your potential participants actually informed and engaged?

You have probably already developed an informed parent permission form as well as a child assent form. Your research protocol may also include having a study team member meet with prospective young participants in order to discuss your study’s protocols and procedures. You probably also have contact information readily available, so that both prospective volunteers and enrolled participants can reach you (the PI and/or Project Director), a team member, and your IRB. However, it is also important to consider whether you are providing young children with information about your research in ways that are proven to be understandable and engaging to them. By doing so, you can be more confident that your participants fully understand what they are being asked to do before they agree to participate.

What do young people want to know about research?

Youth have reported that they want to understand the potential benefits and side effects associated with participating in a research study. They have also reported that they want to know their roles and rights in a clinical trial. Furthermore, they want to be made aware of any expectations that the researchers may have for participating in a study when they are making the decision about whether to participate or not.¹ Young people may not sufficiently understand these types of important information about your study, especially if the information is presented only in a written format. A written communication format does not account for the motivational, cognitive, and emotional differences between young people and adults.

What methods of communication are best to use with youth?

The use of developmentally-appropriate informational materials such as digital comics, animations, and videos of peers may be a more engaging vehicle for sharing information with youth, and may help them to more fully understand information about what participation in your research means. In fact, one study found that children who received information about clinical research in multimedia, digital format demonstrated greater improvements in knowledge about clinical trials than children who received the same information in paper format.²

What are barriers to using developmentally-appropriate materials to recruit youth to participate in research studies?

For an individual researcher interested in applying these findings to offering developmentally-appropriate information about their research in formats that are conducive to engaging and retaining children and adolescents, there are three main barriers to accomplishing this goal.

1. First, it is expensive to create multimedia and professionally graphically designed resources for an individual study.
2. Second, to create and offer these types of resources to reflect the interests of young people, young people need to be involved in the development process which can take years of iterative drafts to achieve a final product.
3. Third, young people today are digital natives, so informational resources need to be accessible and interactive on the web; however, custom web design and web applications development needed to host these types of materials is both expensive and time-consuming, and requires technical expertise to make them accessible to youth with disabilities, which may be beyond the capability of an individual research study or individual research lab.

The research, software, and design teams at iRT have spent years in development to be able to offer a turnkey solution to researchers by creating DigiKnowIt News.

What is the solution that DigiKnowIt News offers for educating potential participants?

DigiKnowIt News includes all of the fundamental information that children and adolescents reported wanting to understand before making the decision to participate in a study, such as:

1. benefits of being in a clinical trial study,
2. side effects of being in a study,
3. roles of study participants and research teams,
4. participants’ rights, and
5. realistic expectations for participation.

Most importantly, information about these topics and more are communicated in an understandable, developmentally-appropriate way through interactive activities and animations, while using a vocabulary that is understandable to children and adolescents.

DigiKnowIt News can be adapted for use by young people of various age groups and with a range of abilities. For example, there are resources specifically designed for children, resources specifically designed for teens, and resources that can be used across ages.

In fact, children and adolescent who explored the developmentally-appropriate versions of the DigiKnowIt News website reported that they liked the content and format of DigiKnowIt News and that they learned new information that could be used to help them make decision in the future.

Another exciting and useful feature of DigiKnowIt News is that you can seamlessly integrate it into your existing informed assenting process through an easy-to-use online procedure, so that you can include and design your DigiKnowIt News website to include only content that is relevant for your specific study. In other words, you can select what modules or information you want, and not use or display any multimedia assets or topics that are is not relevant or needed. DigiKnowIt News can be used to replace or supplement your current informational materials for prospective child or adolescent participants.

The website is affordably priced, so that it is accessible for use by any level of researcher, and use of the website will save researchers thousands of dollars and years of development time that would be needed to create and implement a comparable solution.

If you are interested in using DigiKnowIt News to educate young people about your research study in developmentally-appropriate ways so they may be more likely to participate in your study, click here to get started.

1. Martin-Kerry JM, Knapp P, Atkin K, et al. (2019) Supporting children and young people when making decisions about joining clinical trials: Qualitative study to inform multimedia website development. BMJ Open 9: e023984
2. Tait, A. R., Voepel-Lewis, T., & Levine, R. (2015). Using digital multimedia to improve parents’ and children’s understanding of clinical trials. Archives of Disease in Childhood,100(6), 589–593.

Finding recruitment resources that educate potential participants about your research study’s unique goals and methods, and appeal to your target participant population is challenging. In addition, creating your own custom recruitment materials is expensive and time-consuming.

DigiKnowIt News is a customizable recruitment website software that allows you to create a recruitment website that is unique to your study, so you can recruit your full participant sample and maximize the number of participants you retain through a smooth, quick, cost-effective process.

How can a custom recruitment website help you recruit and retain more participants?

Using a recruitment website that is uniquely created for your individual research study can help your potential participants know exactly what to expect from participating in your specific study and help them feel more confident to participate.

Before children and adolescents can feel comfortable to participate in your research, they must be well informed about the ways they can benefit from participating in your unique study, what their rights are as a participant, and what they can expect to do as part of your study. Because every research study is different, the process of educating potential participants on their rights, benefits of participation, and the methods or procedures involved should look different for every study.

Customized recruitment websites allow researchers to educate their potential participants on important topics about their unique study that broad, generic recruitment materials often leave out.

For example, fear of unfamiliar or uncomfortable medical procedures is a common barrier to clinical trials recruitment. By incorporating content in your custom recruitment website that educates potential participants about the specific medical procedures involved in your clinical trial and addresses common fears associated with them, you can help reduce young people’s fears about participating in your study, so they may be more likely to participate.

By helping children and adolescents know what to expect from participating in your research study, a custom recruitment website can help you not only give young people the confidence to assent to participate but can also help you retain participants. When provided with realistic expectations for participation before the study begins, participants may be less likely to drop out of your study when met with challenges or discomfort.

In addition, customizing your recruitment website to appeal to the developmental interests and needs of the specific subgroup of youth you are recruiting can support your recruitment goals.

By customizing your recruitment website so that it is engaging and developmentally appropriate for your target participant population (e.g., children, adolescents), your potential participants may better understand the information you have provided them with, which may lead them to feel more confident to say “yes” to participating in your study.

How can you customize DigiKnowIt News to better support your recruitment goals?

DigiKnowIt News offers over 20 engaging learning modules that contain interactive activities and a variety of important information that young people should know before deciding to participate in a research study. You can choose which learning modules to include in your recruitment website from a menu of options to create a custom recruitment website that reflects the methods and procedures being used in your unique study.

DigiKnowIt News includes several informative learning modules and activities that you can choose to include in your custom website to teach young people about the specific medical procedures that are involved in your unique clinical trial. DigiKnowIt News includes optional modules and activities on venipuncture, MRI and ultrasound scans, various types of sedation and anesthesia, various types of organ testing, and behavioral treatments.

DigiKnowIt News is also designed to be adaptable for young people with different learning styles. DigiKnowIt News offers educational content in a few different modalities, including web-based modules called “investigations;” interactive, digital activities called “comic books;” and videotaped interviews with young people who have participated in clinical trials called “spotlights.” You can choose which investigations, comic books, and spotlights to include in your custom website so that content can be as short or long and as interactive or passive as you like.

In addition, many of DigiKnowIt News’ web-based modules and activities are available in two different versions, including one version designed to be developmentally appropriate for children and one to be developmentally appropriate for teens. These options are designed to help you create a custom recruitment website that suits the developmental needs and interests of your subgroup of potential participants.

DigiKnowIt News also includes options to create a unique subdomain for your recruitment website, display your study’s or organization’s logo on the website, and customize the design of your participants’ login page on your website. Customizing the design of your recruitment page also provides a friendly, welcoming experience for potential participants that may be wary or nervous about participating in research.

To view the library of optional content you can choose to include in your custom DigiKnowIt News website to meet all of your unique recruitment needs, visit https://digiknowit.com/library/.

One common barrier to recruiting children or adolescents to participate in a pediatric clinical trial or research study is that they often do not understand how they can directly benefit from participating in a study. DigiKnowIt News teaches young people how they can benefit from participating in your research, so they may be more likely to join your study.

When young people are informed about how participating in pediatric research can positively impact their health and well-being, they may feel more motivated to participate in your study. In fact, according to findings from qualitative studies, many children who have participated in clinical trials have reported that health and personal benefits for them were a main reason they chose to participate.^1,2 More specifically, children often choose to participate in clinical trials to learn more about their own diseases, access new medicines or treatment options, receive more monitoring and care from medical professionals, and/or receive a financial reward.

In addition, young people may also be motivated to participate in a study by altruistic reasons in that they believe that their participation can positively impact the health and well-being of others. For example, they may believe that their participation may help future patients receive better treatment for their disease. In addition, they may feel that they are able to “give back” to doctors who have treated them for their disease by helping doctors advance healthcare through participating in their research.¹

Children, adolescents, and their families often make the decision to participate in a study by carefully weighing the benefits and risks associated with participation. If young people are not fully informed about the ways they could benefit from being in a study, they may believe that the potential costs and risks of participating outweigh the potential benefits. Research has shown that this imbalance is associated with children and adolescents having more negative attitudes about research which can ultimately impact their decision to participate in studies.³ Educating young people about the potential benefits of participating in your research prevents families from keeping the perceived costs of participating in research at the forefront in their decision-making process.

So, how can you make sure potential participants are aware of how participating in your research can benefit them?

DigiKnowIt News explains and demonstrates the potential benefits of participating in research to children and adolescents, so researchers can help young people make more informed decisions about participating. The content of the website describes how participating in research could personally benefit participants and their health by providing them with opportunities to learn more about their disease, receive access to medical treatments that are otherwise not yet available to them, and more. In addition, DigiKnowIt News describes why pediatric research is important for the advancement of healthcare, so children can recognize how their participation in research could positively impact others. With an accurate and comprehensive look into their options, young people may feel more comfortable and ready to say “yes” to joining your study.

To learn more about how DigiKnowIt News can help you educate young people so they may be more motivated to participate in your research, visit https://digiknowit.com/ for more information.

1. Luchtenberg, M., Maeckelberghe, E., Locock, L., Powell, L., & Verhagen, A. A. (2015). Young people’s experiences of participation in clinical trials: reasons for taking part. The American Journal of Bioethics, 15(11), 3–13.
2. Martin-Kerry, J. M., Knapp, P., Atkin, K., Bower, P., Watt, I., Stones, C., Higgins, S., Sheridan, R., Preston, J., Taylor, D. H., Baines, P., & Young, B. (2019). Supporting children and young people when making decisions about joining clinical trials: Qualitative study to inform multimedia website development. BMJ Open, 9,
3. Barakat, L. P., Stevens, E., Li, Y., Reilly, A., Deatrick, J .A., Goldstein, N. E., & Schwartz, L. A. (2019). Evaluation of the pediatric research participation questionnaire for measuring attitudes toward cancer clinical trials among adolescents and young adults. Journal of Adolescent and Young Adult Oncology, 8(4), 423–433.

As fellow researchers, we understand that recruiting participants for pediatric research is difficult. Researchers across the nation are struggling to recruit an adequate number of children or adolescents to participate in their research studies and clinical trials.

DigiKnowIt News is a multimedia, educational website that addresses the most common barriers to pediatric research participation to help you recruit more children and adolescents for your study.

So, why are children hesitant to participate in research studies, and what can you do about it?

Not only is the pool of potential participants smaller for pediatric studies than studies for adults, but many children and adolescents are reluctant to participate in research at all. Research has shown that fear of risks, lack of information, and misinformation about pediatric clinical trials are the main reasons children and parents are unmotivated or unwilling to participate in research.¹ When children and adolescents do not understand what research studies are, why they are important, or what they may be asked to do as a participant, they are likely to feel nervous to be involved.

If your study involves medical procedures, either invasive, such as venipuncture, or noninvasive, such as MRI or ultrasound scans, children may be afraid that the procedures will be painful or uncomfortable for them. Children or teenagers may also just have a fear of the unknown if your study involves them experiencing a medical or diagnostic procedure that is unfamiliar to them.

Several studies have found that young people’s fears of potential side effects of clinical trials treatment, prolonged hospitalization, and discomfort with experimentation are common reasons they view research participation negatively.² In these situations, education that explains what it means to participate in an actual trial and the value of doing so may help mitigate these fears.

In addition, children are often concerned that the time it would take them to participate in a study would take their time away from being with their friends or from participating in their hobbies.³ Children and teenagers in today’s world are busy with afterschool activities and especially since the COVID-19 pandemic, want to maximize time with their friends. Research has shown that quarantining and social distancing practices during the pandemic caused children and adolescents to reflect more on the irreplaceable nature of friendship and unsuspected benefits of in-school instruction for socialization.⁴ For this reason, young people may place higher value on the time they are able to spend with their peers post-pandemic. In addition, children have been spending more of their leisure time outdoors, have joined sports clubs more often, and have spent less time on screens in the past few years compared to before the pandemic.⁵

Children may have preexisting attitudes or beliefs about research that deter them from participating, such as beliefs that researchers are untrustworthy or deceptive. Educating young people on the roles of researchers and medical professionals leading a research study as well as the laws that researchers must follow to protect participants may help young people form more positive attitudes towards research. In addition, providing examples to potential participants of what it is like to interact with research staff, such as demonstrating how researchers can answer participants’ questions and how participants can speak with medical staff during medical procedures, may ease their anxiety by helping them to know what to expect before, during, and after participation.

Young people may also be unaware of the many ways that participating in research can benefit them and feel that participating is not worth their time or efforts. They may be more open to research participation after receiving training or having educational experiences that help them to understand the many benefits of participating in research.

What can you do to increase participation rates?

Our team of researchers and web developers created the DigiKnowIt News customizable website specifically to help researchers address these common recruitment barriers and meet their recruitment goals. DigiKnowIt News can be used to educate children and adolescents about what clinical trials are, how they can benefit from participation, and what their rights are as participants, so they feel more comfortable participating in research. Each researcher can choose what topics and educational materials to include in their custom website, so they can educate their potential participants on the specific medical procedures involved in their unique clinical trial. For example, researchers can choose to include interactive, informative modules on procedures such as venipuncture, MRI, organ testing, sedation, and anesthesia.

DigiKnowIt News was strategically designed to help you recruit more young people for your research, establish trust with participants, and involve youth in the decision-making process before and during study participation. To learn more about DigiKnowIt News and how it can help you recruit young people for your research, visit https://digiknowit.com/overview/ for more information.

1. Tromp, K., Zwaan, C. M., & van de Vathorst, S. (2016). Motivations of children and their parents to participate in drug research: a systematic review. European Journal of Pediatrics, 175(5), 599–612.
2. Forcina, V., Vakeesan, B., Paulo, C., Mitchell, L., Bell, J. A., Tam, S., Wang, K., Gupta, A. A., &Lewin, J. (2018). Perceptions and attitudes toward clinical trials in adolescent and young adults with cancer: a systematic review. Adolescent Health, Medicine and Therapeutics, 9, 87–94.
3. Greenberg, R. G., Gamel, B., Bloom, D. Bradley, J., Jafri, H. S., Hinton, D., Nambiar, S., Wheeler, C., Tiernan, R., Smith, P. B., Roberts, J., & Benjamin, D. K. (2018). Parents’ perceived obstacles to pediatric clinical trial participation: findings from the clinical trials transformation initiative. Contemporary Clinical Trials Communications, 9, 33–39.
4. Larivière-Bastien, D., Aubuchon, O., Blondin, A., Dupont, D., Libenstein, J., Séguin, F., Tremblay, A., Zarglayoun, H., Herba, C. M., & Beauchamp, M. H. (2022). Children’s perspectives on friendships and socialization during the COVID-19 pandemic: A qualitative approach. Child: care, health and development, 48(6), 1017–1030. https://doi.org/10.1111/cch.12998
5. de Bruijn, A. G. M., Te Wierike, S. C. M., & Mombarg, R. (2023). Trends in and relations between children’s health-related behaviors pre-, mid- and post-Covid. European journal of public health, 33(2), 196–201. https://doi.org/10.1093/eurpub/ckad007

Use of incomplete or developmentally inappropriate materials in the assenting process might result in selection bias, insufficient sample size, under- or over-representation of certain groups of youth, costly delays in recruitment, or even high rates of attrition in studies over time. However, many researchers struggle to find materials to use in their assenting process that are comprehensive and developmentally appropriate for their target participant population.

DigiKnowIt News is an educational website that you can seamlessly integrate into your assenting process to recruit more children and adolescents for your research and minimize attrition.

Why should you consider changing your current assenting process?

The importance of informed assent in pediatric research cannot be understated. Not only is the informed assent process vital for respecting participants’ autonomy and complying with good clinical practice guidelines, but it is also a key opportunity for researchers to achieve their recruitment and retention goals.

Children and adolescents may feel too nervous or unprepared to participate in research if they are not adequately informed about their rights as participants and what they may be asked to do as part of your research study or clinical trial. In addition, participants who are not well-informed about the purpose and methods being used in a study may have unrealistic expectations about their participation, which can cause them to lose motivation to participate over time, especially when met with any unexpected challenges or discomfort.

Therefore, if you are experiencing low participation rates or high attrition rates, it may be because your participants are not adequately informed about your study’s goals and methods. Modifying your informed assenting process to effectively inform potential participants may help them feel more comfortable and motivated to participate fully in your research, so you can meet your goals.

Why is your current informed assent process not working?

Pediatric researchers face a unique challenge to educating their potential participants. Properly informing participants should look different for pediatric research studies than studies for adults, but popular informed assent practices do not reflect that. Children are usually not involved in the process of choosing the design or methods of delivering information about clinical research to children, so many potential participants end up receiving information that is neither engaging, comprehensible, nor appealing to them.

Assent forms and in-person meetings with health care providers are the most common ways children and adolescents are informed about clinical trials and their rights before participating. However, health care providers have reported that they find it difficult to maintain young people’s attention and provide balanced information to families during informed consent meetings.¹ In addition, research has shown that assent forms and participant information sheets are often long and difficult for young people to understand.²

Therefore, just because you have provided information to your potential participants about their rights, and the goals and methods being used in your study, does not necessarily mean children were able to understand or retain the information well enough for them to remember it, to decide if they think your study will benefit them, and to decide whether they want to participate in it.

How can you elevate your assenting process for better results?

Research has shown that delivering information about study participation to children and adolescents in a multimedia, digital format may improve potential participants’ knowledge about clinical trials. These methods also may be more understandable for young people than delivering the same information in paper format.³

By delivering information in a way that is entertaining and appeals to multiple different learning styles, you may be able to help potential participants better understand and retain information about study participation, so they feel comfortable beginning and continuing participation in your research.

Creating an engaging and developmentally-appropriate informed assent process for potential participants does not have to be expensive or time consuming. DigiKnowIt News is an engaging, developmentally-appropriate, multimedia website containing the information that children and adolescents need to understand what clinical trials are, what might be involved if they participate, and what their rights are as a participant. When you purchase access to DigiKnowIt News for your study, you get access to a web application that cost over $2 million to develop and evaluate.

DigiKnowIt News was designed to help researchers upgrade their informed assent processes to improve their participant recruitment and retention rates without each researcher having to spend all of the time, money, or resources that were needed to create these interactive, flexible, and multimedia resources.

If you are looking for research-based, cost-effective ways to educate potential participants for better participation rates in your research, DigiKnowIt News can help.

To learn more about how DigiKnowIt News can help you, visit https://digiknowit.com/.

1. Barakat, L. P., Schwartz, L. A., Reilly, A., Deatrick, J. A., & Balis, F. (2014). Perceived barriers and benefits of Phase III clinical trials participation for adolescents and young adults with cancer (AYA): A qualitative study of AYA decision making experiences. Journal of Adolescent and Young Adult Oncology, 3(1), 3–11.
2. Ménoni, V., Lucas, N., Leforestier, J. F., Doz, F., Chatellier, G., Jacqz-Aigain, E., Giraud, C., Tréluyer, J . M., & Chappuy, H. (2011). Readability of the written study information in pediatric research in France. PLoS One, 6(4), e18484.
3. Tait, A. R., Voepel-Lewis, T., & Levine, R. (2015). Using digital multimedia to improve parents’ and children’s understanding of clinical trials. Archives of Disease in Childhood, 100(6), 589–593.