Web-based Resource for Children and Adolescents About Clinical Research
Phase: NA
Conditions: Healthy, Chronic Illnesses, Multiple
Sponsor: Innovation Research & Training

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Study Protocol and Statistical Analysis Plan 
 
Title of Study: Web-based Resource for Children and Adolescents About Clinical Research 
NCT Number: NCT04448210 
Date of Document: June 18, 2020 
 

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Table of contents 
 
Page number 
Study Protocol 
3 
  Objectives  
3 
  Design 
3 
  Methods 
3 
Statistical Analysis Plan 
5 
 
 

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Study Protocol 
 
Objectives:  
 
DigiKnowIt News: Teen (DKIN: Teen) is an interactive educational website designed to educate 
adolescents (aged 12 to 17) about pediatric clinical research. The main objective of the study is 
to examine the feasibility of DKIN: Teen and its impact on adolescents’ knowledge about 
pediatric clinical trials; self-efficacy about making decisions about participation in clinical 
research; positive attitudes and beliefs towards participation; and fears related to participating in 
clinical trials. 
 
Design:  
 
A small randomized controlled trial design will be conducted online at two time points: 1) 
baseline/pre-test and 2) post-test (one week after pre-test). The study questionnaires will be 
programmed into an online data collection system and the intervention itself is also completed 
online. 
 
Participants will be randomly assigned to one of two conditions: 1) intervention (youth will 
receive access to DKIN: Teen right away) or 2) wait-list control (youth will not have access to 
the intervention between pre-test and post-test assessments; after completing the post-test 
questionnaire, youth will be given the option to review DKIN: Teen).  
 
Methods:  
 
 
Sample and Recruitment. Youth between the ages of 12 and 17 will be recruited for the 
study.  To be eligible to participate in the study, the following criteria must be met. Youth in the 
study must: 1) be between the ages of 12 and 17 years; 2) understand English because the 
resource and questionnaires are in English; 3) have access to a computer or tablet with internet 
access for the duration of the study as the intervention and questionnaires are web-based; 4) NOT 
currently be in or have previously participated in a clinical trial. This study will investigate if the 
intervention improves attitudes and decision-making of youth who have not yet participated in a 
clinical trial; thus, excluding those who have already had the experience of being in a clinical 
trial.  Youth will be recruited from across the United States via flyers and a study website in 
addition to recruitment efforts via Peachjar (digital flyer service used by school districts) and 
pediatric health organizations and advocacy groups. Efforts will be made to ensure that the 
intervention and wait-list control groups have about equal amounts of boys and girls as well as 
healthy youth and youth with varying chronic diseases/disorders and represent diversity in race 
and ethnicity.  
 
Procedure.  Parents of interested adolescents will visit the study recruitment website to 
learn more about the study and respond to the study eligibility screening questions. Parents will 
be notified onscreen immediately if their child is eligible to participate in the study, and if so, 
will be given access to online permission and assent forms. They will be instructed to review the 
forms together so they can decide about participation. Interested participants who decide to 
complete the forms will be told that in an attempt to have a diverse sample, they may not be 

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invited to participate. Families can contact the research team about any questions they might 
have after they have reviewed and signed the forms. Participants and their parents will be 
instructed to read the permission and assent forms and provide online permission and assent by 
typing their names into a text box, providing contact information, and clicking a button to 
indicate permission (parent) or assent (youth), rather than providing a signed hard copy of the 
forms. They will have the option to download and/or print the forms to retain a copy for their 
files. Only participants with permission and assent will be permitted to participate in the study.  
Eligible youth who have assent and have parent permission will be sent an email invitation to 
participate to their parent by project staff members if there is space for them in the study 
depending on their demographic characteristics.  
 
Participants will be randomized, stratifying based upon gender (boy/girl/non-binary), 
race/ethnicity (white/nonwhite), and health status (healthy/chronic illness), to either the 
intervention group (DKIN: Teen) or wait-list control group. A research team member will enroll 
the participants into their assigned groups using an online study management system. All 
participants will be assigned a unique ID number that will be associated with their data in place 
of a name. Parents will receive an enrollment email from the study management system with a 
link for participating youth to complete the online pretest questionnaire. Next, parents of youth 
participants in the intervention group will be emailed instructions on how to access DKIN: Teen.  
Youth will be asked to review as much of it as they want within one week.  DKIN: Teen is 
expected to take about 1 hour to fully complete and can done in more than one sitting. Project 
staff members will monitor website usage through a Learning Management System (LMS). 
Participants in the wait-list control group will receive business-as-usual, which in this case is no 
information to review about clinical trials.  
 
About one week after completing the pretest, all parents will receive a link for youth participants 
to access the online posttest. At the end of the posttest, the youth in the intervention group will 
also receive the Consumer Satisfaction Questionnaire to give feedback about the website. Youth 
participants in the wait-list control group will have the option of reviewing DKIN: Teen after 
their posttest data have been collected through an email link to their parents. After a week, the 
wait-list control group will also have the opportunity to complete the Consumer Satisfaction 
Questionnaire. Parents will receive automatic email reminders from the study management 
system if their teen has not completed the questionnaires or has not accessed DKIN: Teen.  The 
research team will also call a parent or send a check-in email to a parent if there is no response 
following the automatic reminder. Youth will receive $20 for the completing the pretest 
questionnaire and $30 for completing the posttest via gift cards.  At the end of the study, 
responses on the online questionnaires will be downloaded from the online data collection 
system and saved on a secure, password-protected network in preparation for statistical analyses.  
 
Measures.  
 
Knowledge. This measure has been created for the purposes of this study. Youth will respond to 
questions that assess their factual knowledge about clinical research (e.g., What is a clinical 
trial?). Questions are in multiple choice format (some questions have multiple correct answers), 
and the total score will be calculated. 
 

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Attitudes and Beliefs (adapted from Madsen, Mirza, Holm, Hilsted, & Riis, 2002). Youth will 
be asked to respond to questions that assess their positive attitudes about clinical trials (e.g., How 
do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 
3=Not sure; 4=Good; 5=Very good) and questions that assess their beliefs about positive aspects 
of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly 
Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). 
 
Self-Efficacy (adapted from Bandura, 2006). Youth will be asked to respond to questions 
related to their self-efficacy for making decisions related to participation in clinical trials for two 
areas: 1) gathering information about clinical trials (e.g., Ask my parents questions for more 
information about clinical trials?); 2) communicating about clinical trials (e.g., Tell the 
researcher that I don’t want to participate in the clinical trial, even if they really want me to do 
it). Youth will rate each question on a 5-point Likert scale (1 = I cannot do it at all; 5 = I know I 
can do it). Youth will be asked to respond to additional items to measure youths’ confidence for 
participating clinical trials (e.g., I know what rights I have in a clinical trial.  I know whom to ask 
if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 
4=Agree; 5=Strongly Agree). 
 
Procedural fears (adapted from Kowalsky, France, France, Whitehouse, & Himawan, 2014). 
Youth will be asked to respond to questions related to their perceptions of fear or anxiety about 
different types of medical procedures, including getting a needle in the arm, injection in the leg, 
getting a scan, and taking new medicine, on a 5-point Likert scale (1 = Not at all afraid or 
anxious, 2 = Somewhat afraid or anxious, 3 = Moderately afraid or anxious, 4 = Very afraid or 
anxious, 5 = Extremely afraid or anxious).  
 
Fidelity of Implementation. iRT’s LMS will record the amount of time that users spend on the 
website components and the specific components that were reviewed.  
 
Consumer Satisfaction Questionnaire (CSQ) will assess satisfaction for each of the three 
components of the website in terms of:  (1) content (e.g., The information in the Spotlights was 
interesting to me.); (2) format (e.g., I liked that there were games and activities I could play in 
the Investigations.); (3) usability (e.g., I could figure out how to make the Comics work.).  
Overall quality will also be assessed (e.g., I would recommend this resource to a friend that was 
considering participating in research.).  Participants will rate each item on a 5-point Likert scale 
(1 = Strongly Disagree, 2 = Disagree, 3 = Undecided, 4 = Agree, and 5 = Strongly Agree).   
 
Statistical Analysis Plan 
 
Preliminary Analyses.  Chi-squared analyses will be used to examine if the randomization 
process produced equivalent groups between the wait-list control and intervention groups with 
respect to gender, race, ethnicity, health status, and SES. A t-test will be used to examine if the 
randomization process produced equivalent groups between the wait-list control and intervention 
groups with respect to age.  If any of these demographical variables are found to differ 
significantly between the two groups, they will be included as covariates in the main analyses. 
Finally, the outcome variables will be examined to see if the values are normally distributed. 
 

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Main Analyses. Intent-to-treat (ITT) analyses will focus on examining the feasibility of 
DKIN: Teen for making positive changes in youth outcomes related to participation in clinical 
trials.  A series of single factor, condition (intervention, wait-list control) random effects 
ANOVA models will be used to examine if using DKIN: Teen impacts the posttest 1) 
knowledge, 2) attitudes, 3) beliefs, 4) self-efficacy, 5) fears related to participation as well as 
likelihood to participate and 6) likelihood that fears would prevent participation. Pretest scores 
for each outcome will be included as predictor variables; therefore, outcome variable means will 
be adjusted posttest scores. Because this study is not powered to find significant differences (i.e., 
p-values) between groups, small or larger effect sizes (Cohen’s d) will be emphasized during 
interpretation as evidence of feasibility.