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 
ClinicalTrial.gov Identifier: NCT05714943 
Principal Investigators: Alison Parker; Tracy Scull 
Date of Document: 01/24/2023 
 
 
 
 
 

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Table of contents 
 
Page number 
Study Protocol 
3 
  Objectives  
3 
  Design 
3 
  Methods 
4 
Statistical Analysis Plan 
10 
 
 

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Study Protocol 
 
Objectives:  
 
Clinical trials with pediatric populations are needed in order to ensure the treatments are tested 
with and work for children and adolescents. However, there are a number of barriers to 
recruitment and enrollment of children and adolescents. DigiKnowIt News: Teen (DKIN: Teen) is 
an interactive educational website designed to educate adolescents (aged 12 to 17) about 
pediatric clinical research and equip them with information to make informed decisions about 
participation. The main objective of the study is to test the effectiveness of DKIN: Teen related 
to factors that could influence participation in pediatric clinical trials. This study will examine if 
DKIN: Teen increases adolescents’ knowledge about clinical trials, adolescents’ and parents’ 
positive attitudes and beliefs towards clinical trials, adolescents’ self-efficacy about the decision 
to participate in a clinical trial, adolescents’ and parents’ likelihood and willingness to participate 
in a clinical trial, and adolescents’ and parents’ communication quality, as well as reduce 
adolescents’ fears associated with research participation.  
 
Design: 
 
The study is a parallel group randomized controlled trial with a 1:1 allocation ratio and 
superiority framework to test the efficacy of DKIN: Teen for improving factors related to clinical 
trial participation among parent-adolescent pairs. The randomized controlled trial 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 randomized, stratifying based upon gender (boy; girl; non-binary), 
race/ethnicity (white and not Hispanic/Latino; nonwhite and/or Hispanic/Latino), and health 
status (health;/chronic illness), to one of two conditions: 1) intervention (pairs will receive access 
to DKIN: Teen right away) or 2) wait-list control (pairs will not have access to the intervention 
between pre-test and post-test assessments; after completing the post-test questionnaire, pairs 
will be given the option to review DKIN: Teen).  
 
Participants are randomized and enrolled based on: 1) time study forms (e.g., consent) were 
completed, 2) confirmation of email addresses, and, 3) their reported demographics collected in 
the eligibility screener questions (described below in the Sample and Recruitment section). One 
of the leading investigators will generate the allocation sequences using a random number 
generator in Excel.  After eligibility is determined, the other leading investigator will assign 
participants to condition (either intervention or wait-list control) according to those sequences 
and then enroll participants in the study. The allocation sequence will be stored in a folder on a 
secure, password-protected server and will only be accessible by the leading investigator who 
created the sequence. All participants will be assigned a unique ID number that will be 
associated with their data in place of a name.  
 
 
 

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Methods:  
 
Sample and Recruitment. Parent-adolescent (ages between 12 and 17 years) pairs will be 
recruited for the study.  To be eligible to participate in the study, the following criteria must be 
met: a) adult participant is a parent or legal guardian of adolescent participant; (b) adolescent 
participant is 12-17 years of age; (c) parent-adolescent pair has access to a computer or tablet 
with internet connection; (d) ability to speak and read in English; and (e) no current or previous 
participation in a clinical trial after kindergarten. This study will investigate if the DKIN: Teen 
website improves attitudes and decision-making of adolescents who have not yet participated in 
a clinical trial and thus, excludes those who have already had the experience of being in a clinical 
trial. Parent-adolescent pairs will be recruited from across the United States. A study recruitment 
website will contain information about DKIN: Teen and the research study that interested parent-
adolescent pairs can review. Parent-adolescent pairs will also be recruited via flyers and with the 
help of consultants who have access to networks of pediatric groups and pediatric health 
organizations, as well as help from other health advocacy and parent groups. Study flyers will 
also be shared via email and social media (e.g., Facebook) and via PeachJar, a digital flyer 
service within school districts. Efforts will be made to ensure about equal samples of boys and 
girls as well as healthy adolescents and adolescents with varying chronic diseases/disorders 
between the intervention and wait-list control groups. The sample will represent diversity in 
ethnicity and race.  
 
Procedure.  Interested parents and adolescents will visit the recruitment website to learn 
more about the study and respond to the study eligibility screening questions. In order to be 
eligible to participate in the study, a parent-adolescent pair must have access to computer or 
tablet with internet connection and English fluency. In addition, the adolescent participant must 
be within the ages of 12-17 and have NOT participated in a clinical trial. Parents will be asked to 
indicate their child’s race, ethnicity, gender, and health status (healthy/have chronic illness) to 
assist in ensuring a diverse sample of participants. Parents will also be asked to indicate their 
own gender, race, and ethnicity. 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, consent, 
and assent forms. They will be instructed to review the forms together so they can decide about 
participation. Parents will complete an online consent form for their own participation and 
permission form for their child’s participation and the adolescent will be asked to complete an 
online assent form. Interested participants who decide to complete the forms will be told that in 
an attempt to have a diverse sample, they may not be invited to participate. Parent-adolescent 
pairs can contact the research team about any questions they might have after they have reviewed 
and signed the forms.  
The permission, consent, and assent forms will describe the goals of the study, as well as 
the minor potential risks and the benefits of participation. Permission, consent, and assent forms 
will also state the participant may discontinue their participation at any time. Parents will be 
provided with the option to receive text messages related to their study participation in addition 
to receiving emails. Language in the adolescent assent will be appropriate for the age group in 
the study, in order to ensure that they understand all procedures. Potential parent-adolescent pairs 
will be provided with the contact information of the researchers and may contact them to ask any 
questions they may have about the study. Only parent-adolescent pairs with completed study 
forms will be permitted to participate in the study. Parent-adolescent pairs will read the 

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permission, consent, and assent forms and provide online permission, consent and assent by 
typing their names into a text box, providing contact information, and clicking a button to 
indicate permission and consent (parent) or assent (adolescent), rather than providing us with 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. 
iRT project staff will determine whether or not the address the parent has provided for the 
pair in the informed consent forms is real using a Google map search. Eligible parent-adolescent 
pairs who have completed all study forms (parental consent and permission and adolescent 
assent) will be invited to participate by project staff members if there is space for them in the 
study depending on their demographic characteristics. Parents will receive a welcome email that 
will provide more information on the timeframe and tasks for the study. Approximately equal 
numbers of male/female adolescent participants and chronically ill/healthy adolescent 
participants will be randomly assigned to condition (DKIN: Teen OR wait-list control). The goal 
is to enroll a diverse sample of adolescents with respect to race and ethnicity.  
When the study starts, parent-adolescent pairs will receive an enrollment email (and text 
message - if the family has opted-in to receive text messages) from iRT’s study management 
system via the parent’s email address (and phone) with a link for the participating parent to 
complete the online parent pretest questionnaire within one week. This enrollment email (and 
text) will also indicate that the parent will receive a second message with a unique link for their 
adolescents to use to complete the online teen pretest questionnaire within one week. Completion 
of the pretest questionnaires may take up to 30 minutes for adolescents and 15 minutes for 
parents. Upon completion of the pretest questionnaires, parent-adolescent pairs will see a 
message at the end of the questionnaire indicating that the parent will receive an email (and text) 
regarding the pair’s next steps in the research study.  
• Pairs in the intervention group will receive an email (and text) that they are able 
to access DKIN: Teen immediately with instructions on how to access and review 
DKIN: Teen. The DKIN: Teen website is expected to take about up to 2 hours to 
fully complete and can be done in more than one sitting.  
• Pairs in the wait-list control group will receive an email (and text) telling them 
that they will be asked to complete another set of questionnaires in about one 
week.  Participants in the wait-list control group will not have access the DKIN: 
Teen during this time and will receive business as usual, which in this case is no 
clinical trial information. The wait-list control group will later receive access to 
DKIN: Teen once they have completed the posttest questionnaires.  
 
Project staff members will monitor DKIN: Teen website usage through iRT’s Learning 
Management System (LMS).  Approximately one week after completing the pretest 
questionnaire, participating parents will receive an email (and text) with a link for the parent to 
access the online parent posttest questionnaire to be completed within one week. This parent 
email (and text) will also indicate that the parent will receive another message with a unique link 
for their adolescents to use to complete the online teen posttest questionnaire within one week. 
Completion of the posttest questionnaires may take up to 30 minutes for adolescents and 15 
minutes for parents.  Participants in the intervention group will receive the Consumer 
Satisfaction Questionnaire at the end of their posttest questionnaire. Completion of the Consumer 
Satisfaction Questionnaire may take approximately 15 minutes.  

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Participants in the wait-list control group will have the option of reviewing DKIN: Teen 
after their posttest data have been collected.  After a week, the wait-list control group will have 
the opportunity to complete the Consumer Satisfaction Questionnaire about DKIN: Teen. 
Completion of the Consumer Satisfaction Questionnaires by participants in the wait-list control 
group is optional and those participants will not receive an incentive for completing these 
questionnaires. Parents (in the wait-list control group) will receive an email (and text) with a link 
for the parent to access the online parent Consumer Satisfaction Questionnaire to be completed 
within one week. This email (and text) will also indicate that the parent will receive another 
message with a unique link for their adolescents to use to complete the online teen Consumer 
Satisfaction Questionnaire within one week. 
Participants will receive automatic email (and text) reminders from the study 
management system if they have not completed the questionnaires or 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. Incentives for completing the pretest questionnaires 
and for completing the posttest questionnaires will be physically mailed to parent-adolescent 
pairs using the address provided on their study forms. 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.  
 
Adolescents 
 
Knowledge. This measure has been created for the purposes of this study. Adolescents will 
respond to 27 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 could range from 0-53 correct. Higher scores indicate more 
knowledge about clinical research. 
 
Attitudes about clinical trials. This measure was originally adapted from Madsen and colleagues 
(2002) and used in Parker et al (2022). The items are slightly adapted. Adolescents will be asked 
to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you 
feel about teens participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 
4=Good; 5=Very good; α = 0.83). Responses will be averaged and the minimum scale score is 1 
and the maximum scale score is 5. Higher scores indicate more positive attitudes toward clinical 
trials. 
 
Beliefs about clinical trials. Adolescents will be asked to respond to 5 questions about their 
beliefs about pediatric clinical research (e.g., I believe that clinical trials can help teens; 
1=Strongly disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly agree; α = 0.78; Parker et al., 
2022). Responses will be averaged and the minimum scale score is 1 and the maximum scale 
score is 5. Higher scores indicate more positive beliefs about clinical trials. 
 
Self-efficacy to communicate. This measure was originally adapted from Bandura (2006) and 
used in Parker et al. (2022). The items were slightly adapted and split into two scales (self-
efficacy to communicate and self-efficacy to gather information, below). Adolescents will be 

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asked to respond to 10 questions about their self-efficacy for making decisions about clinical trial 
participation specific to communicating about clinical trials (e.g., Tell a doctor or researcher if I 
want to stop the clinical trial; 1 = I cannot do it at all; 5 = I know I can do it; α = 0.89; Parker et 
al., 2022). Responses will be averaged and the minimum scale score is 1 and the maximum scale 
score is 5. Higher scores indicate more self-efficacy about communication. 
 
Self-efficacy to gather information. This measure was originally adapted from Bandura (2006) 
and used in Parker et al. (2022). Adolescents will be asked to respond to 9 questions about their 
self-efficacy for making decisions about clinical trial participation specific to gathering 
information about clinical trials (e.g., Ask a doctor or researcher questions for more information 
about clinical trials; 1 = I cannot do it at all; 5 = I know I can do it; α = 0.89; Parker et al., 2022). 
Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. 
Higher scores indicate more self-efficacy about gathering information. 
 
Confidence for participating in clinical trials. Adolescents will also be asked to respond to 
additional items to measure youths’ confidence for participating in clinical trials (e.g., “I know 
what rights I have in a clinical trial.”; 1=Strongly disagree; 2=Disagree; 3=Unsure; 4=Agree; 
5=Strongly agree; α = 0.77; Parker et al., 2022). Responses will be averaged and the minimum 
scale score is 1 and the maximum scale score is 5. Higher scores indicate more confidence in 
participating in clinical trials. 
 
Procedural fears. Adolescents will be asked to respond to 4 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). Responses will 
be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores 
indicate more fear about procedures. The original measure has strong reliability and validity 
(Kowalsky et al., 2014).  
 
Likelihood of participation in clinical trials. Adolescents will be asked to respond to one 
question about the likelihood of participating in a clinical trial (i.e., “If you were asked to be in a 
clinical trial, how likely would you be to participate?”) using a 5-point Likert scale (1 = Not 
likely at all; 2 = Not very likely; 3 = Not sure; 4 = Likely; 5 = Very likely). Responses will be 
averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores 
indicate greater likelihood of participation in a clinical trial. 
 
Likelihood of fear preventing participation in clinical trials. Adolescents will be asked to 
respond to one question about the likelihood of their fear preventing them from participating in a 
clinical trial (i.e., “How likely is it that your fearful or anxious feelings could stop you from 
participating in a clinical trial in the future?”) using a 5-point Likert scale (1 = Not likely; 2 = 
Somewhat likely; 3 = Moderately likely; 4 = Very likely; 5 = Extremely likely). Responses will 
be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores 
indicate greater likelihood of fear preventing participation in a clinical trial.  
 

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Familiarity with clinical trials. Adolescents will be asked to respond to one question about their 
familiarity with clinical trials [“How much do you know about pediatric clinical trials (research 
studies with children under 18)?”; 1 = I don’t know anything; 2 = I know a little about them; 3 = 
I know some things about them; 4 = I know a lot about them; 5 = I know all there is to know 
about them]. Responses will be averaged and the minimum scale score is 1 and the maximum 
scale score is 5. Higher scores indicate greater familiarity with pediatric clinical trials. 
 
Willingness to participate in a clinical trial. Adolescents will review five research protocols 
related to a fictitious disease (‘meditis’) and respond to a question about their willingness to 
participate in each research study (e.g., If you had meditis, would you agree to enroll in this 
study?; 1 = Definitely not to 7 = Definitely yes). Responses will be averaged across the five 
protocols and the minimum scale score is 1 and the maximum scale score is 7. Higher scores 
indicate greater willingness to participate in the research studies. This measure was adapted from 
Brody and colleagues (2005). 
 
Quality of parent-adolescent communication. Adolescents will be asked to respond to 8 
questions related to their perceptions of their relationship quality and communication with their 
parents (e.g., “My parent gives me good advice.”; “When talking to my parent, he/she tries to 
understand my point of view.”; 1 = Strongly disagree; 2 = Disagree; 3 = Agree; 4 = Strongly 
agree). Responses will be averaged and the minimum scale score is 1 and the maximum scale 
score is 4. Higher scores indicate more positive perceptions of relationship quality. This measure 
has strong reliability (Mallett et al., 2011).  
 
Parents 
 
Attitudes about clinical trials. Parents will be asked to respond to 6 questions that assess their 
positive attitudes about clinical trials (e.g., How do you feel about teens participating in clinical 
trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses will 
be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores 
indicate more positive attitudes toward clinical trials. This measure was adapted from Madsen 
and colleagues (2002) and used in Parker et al (2022). 
 
Beliefs about clinical trials. Parents will be asked to respond to 5 questions about their beliefs 
about pediatric clinical research (e.g., I believe that clinical trials can help teens; 1=Strongly 
disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly agree). Responses will be averaged and 
the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate more 
positive beliefs about clinical trials. This measure was adapted from Parker et al (2022). 
 
Likelihood of participation in clinical trials. Parents will be asked to respond to one question 
about the likelihood of allowing their child to participate in a clinical trial (i.e., “If your child 
were asked to be in a clinical trial, how likely would you be to let them participate?”) using a 5-
point Likert scale (1 = Not likely at all; 2 = Not very likely; 3 = Not sure; 4 = Likely; 5 = Very 
Likely). Responses will be averaged and the minimum scale score is 1 and the maximum scale 
score is 5. Higher scores indicate greater likelihood of allowing child to participate in a clinical 
trial. 

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Likelihood of fear preventing participation in clinical trials. Parents will be asked to respond to 
one question about the likelihood of their fear preventing them from allowing their child to 
participate in a clinical trial (i.e., “How likely is it that your fearful or anxious feelings could stop 
you from allowing your child to participate in a clinical trial in the future?”) using a 5-point 
Likert scale (1 = Not likely; 2 = Somewhat likely; 3 = Moderately likely; 4 = Very likely; 5 = 
Extremely likely). Responses will be averaged and the minimum scale score is 1 and the 
maximum scale score is 5. Higher scores indicate greater likelihood of fear preventing their 
child’s participation in a clinical trial. 
 
Familiarity with clinical trials. Parents will be asked to respond to one question about their 
familiarity with clinical trials [“How much do you know about pediatric clinical trials (research 
studies with children under 18)?”; 1 = I don’t know anything; 2 = I know a little about them; 3 = 
I know some things about them; 4 = I know a lot about them; 5 = I know all there is to know 
about them.]. Responses will be averaged and the minimum scale score is 1 and the maximum 
scale score is 5. Higher scores indicate greater familiarity with pediatric clinical trials. 
 
Willingness to participate in a clinical trial. Parents will review 5 research protocols related to a 
fictitious disease (‘meditis’) and respond to questions about their willingness to let their child 
participate in each research study (i.e., “If your child had meditis, would you agree to enroll them 
in this study?”; 1 = Definitely not to 7 = Definitely yes). Responses will be averaged across the 
five protocols and the minimum scale score is 1 and the maximum scale score is 7. Higher scores 
indicate greater willingness to allow their child to participate in the research studies. This 
measure was adapted from Brody and colleagues (2005). 
 
Quality of parent-adolescent communication. This measure was adapted from Barnes & Olson 
(Barnes & Olson, 1982) and used in Scull et al. (2022). Parents will be asked to respond to 16 
questions regarding their perceptions of the quality of communication with their adolescent (e.g., 
“If my child were in trouble, she/he could tell me”; 1 = Strongly disagree, 2 = Disagree; 3 = 
Agree; 4 = Strongly agree; α = 0.85). Responses will be averaged and the minimum scale score 
is 1 and the maximum scale score is 4. Higher scores indicate more positive perceptions of 
relationship quality. 
 
Implementation 
 
Dosage. iRT’s Learning Management System will record the amount of time that 
adolescents and parents spend on the DKIN: Teen website components and the specific 
components reviewed.  
 
Consumer Satisfaction 
 
Consumer Satisfaction Questionnaire for Adolescents (CSQ-A) will assess teen’s 
satisfaction for four sections of DKIN: Teen (Investigations, Comic Books, Spotlight Videos, and 
Parent-Teen Shared Decision-Making) in terms of: (1) content (e.g., The Spotlight Videos were 
interesting to me.); (2) format (e.g., I liked the videos I saw in the Investigations.); (3) usability 
(e.g., I could figure out how to make the Comic Books work.).  Overall quality will also be 
assessed (e.g., I would tell a friend who wanted to know about clinical trials about the 

10 
 
DigiKnowIt News website.).  Participants will rate each item on a 5-point Likert scale (1 = 
Strongly disagree; 5 = Strongly agree). Adolescent participants will also be asked to provide 
open-ended feedback.  
 
Consumer Satisfaction Questionnaire for Parents (CSQ-P) will assess parents’ 
satisfaction with the Parent-Teen Shared Decision-Making section of DKIN: Teen in terms of (1) 
content, (2) format, and (3) usability. Participants will rate each item on a 5-point Likert scale (1 
= Strongly disagree; 5 = Strongly agree). Parents will also be asked to provide open-ended 
feedback. Finally, parents will complete 12 items related to the acceptability (AIM), 
appropriateness (IAM), and feasibility (FIM) of the Shared Decision-Making section, using a 5-
point Likert scale (1 = Completely disagree; 5 = Completely agree; Weiner et al., 2017).  
 
Statistical Analysis Plan 
 
Data will be analyzed using SAS 9.4.  
 
Preliminary analyses. Preliminary analysis will include a test of equivalency between 
groups on demographic background characteristics using chi-squared analyses for categorical 
variables and t-tests for continuous variables. Psychometric analyses will be conducted to 
examine the reliability, validity, and distributions of key variables. Handling variables with poor 
reliability or validity will include modification or elimination of such variables from the analysis 
data sets. Variables with noticeably skewed distributions will be transformed or categorized to 
reduce the impact of non-normality on subsequent analyses. Descriptive statistics will also be 
conducted to examine the distributions, correlations, means, and standard deviations of the 
adolescent and parent outcome variables (listed in the Measures section). 
 
Main analyses. Multiple regression analyses will be used to investigate differences in 
outcomes (i.e., knowledge about clinical research, attitudes and beliefs towards pediatric clinical 
trials, self-efficacy in making decisions related to clinical trials, likelihood and willingness to 
participate in clinical trials, procedural fears, communication quality) using condition 
(intervention; wait-list control) as the independent variable of interest. A series of multiple 
regressions will be used to examine if using DKIN: Teen impacts the post-test knowledge, 
attitudes, efficacy, likelihood and willingness to participate, fears, and communication quality of 
participants. Pre-test scores for each outcome will be included as predictor variables; thus, 
outcome variable means will be reported as adjusted post-test scores. Demographic variables 
found to be non-equivalent between groups will be included as covariates in these models. The 
effect sizes will be calculated by dividing the appropriate contrast parameter by the sample 
standard deviation of the outcome. If unexpected results are obtained, then the process data 
recorded by the LMS (e.g., time spent on parts of DKIN: Teen website) and measures of 
satisfaction will be examined to investigate whether differing dosage or satisfaction levels can 
explain unexpected patterns of findings. Additional analyses will examine subpopulations and 
test age, gender, and health status (chronic illness/no illness) as potential moderators of the 
effectiveness of DKIN: Teen.  
 
Analyses will be intention-to-treat, so that participants who do not adhere to the protocol are still 
included in the analysis in their assigned condition. Missing data will be handled in each 

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outcome analysis with an appropriate imputation method, and estimates and standard errors will 
be adjusted for imputations, if warranted.