Trial Outcomes & Findings for Web-based Resource for Children and Adolescents About Clinical Research (NCT NCT04448210)

Last Updated: 2020-12-19

Results Overview

Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.

Recruitment status

COMPLETED

Study phase

Target enrollment

42 participants

Primary outcome timeframe

1 week

Results posted on

2020-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Educational Website Intervention The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Overall Study STARTED	22	20
Overall Study COMPLETED	22	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Web-based Resource for Children and Adolescents About Clinical Research

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Educational Website Intervention n=22 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).	Total n=42 Participants Total of all reporting groups
Age, Continuous	14.14 years STANDARD_DEVIATION 1.78 • n=5 Participants	14.55 years STANDARD_DEVIATION 1.64 • n=7 Participants	14.33 years STANDARD_DEVIATION 1.71 • n=5 Participants
Sex/Gender, Customized Male	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Sex/Gender, Customized Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex/Gender, Customized Non-Binary	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	12 Participants n=7 Participants	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Baseline Knowledge Scores	35.74 units on a scale STANDARD_DEVIATION 4.96 • n=5 Participants	36.25 units on a scale STANDARD_DEVIATION 4.04 • n=7 Participants	36.00 units on a scale STANDARD_DEVIATION 4.47 • n=5 Participants
Baseline Attitudes Scores	3.76 units on a scale STANDARD_DEVIATION .75 • n=5 Participants	3.85 units on a scale STANDARD_DEVIATION .65 • n=7 Participants	3.80 units on a scale STANDARD_DEVIATION .70 • n=5 Participants
Baseline Beliefs Scores	4.11 units on a scale STANDARD_DEVIATION .64 • n=5 Participants	4.21 units on a scale STANDARD_DEVIATION .51 • n=7 Participants	4.16 units on a scale STANDARD_DEVIATION .58 • n=5 Participants
Baseline Self-Efficacy for Gathering Information Scores	4.23 units on a scale STANDARD_DEVIATION .61 • n=5 Participants	4.21 units on a scale STANDARD_DEVIATION .52 • n=7 Participants	4.22 units on a scale STANDARD_DEVIATION .56 • n=5 Participants
Baseline Self-Efficacy to Communicate Scores	4.49 units on a scale STANDARD_DEVIATION .61 • n=5 Participants	4.56 units on a scale STANDARD_DEVIATION .54 • n=7 Participants	4.52 units on a scale STANDARD_DEVIATION .57 • n=5 Participants
Baseline Confidence Scores	3.39 units on a scale STANDARD_DEVIATION .67 • n=5 Participants	3.35 units on a scale STANDARD_DEVIATION .63 • n=7 Participants	3.37 units on a scale STANDARD_DEVIATION .64 • n=5 Participants
Baseline Procedural Fears Scores	2.28 units on a scale STANDARD_DEVIATION .75 • n=5 Participants	2.46 units on a scale STANDARD_DEVIATION .80 • n=7 Participants	2.37 units on a scale STANDARD_DEVIATION .77 • n=5 Participants
Baseline Likelihood of Participation Scores	3.57 units on a scale STANDARD_DEVIATION .98 • n=5 Participants	3.74 units on a scale STANDARD_DEVIATION .81 • n=7 Participants	3.65 units on a scale STANDARD_DEVIATION .89 • n=5 Participants
Baseline Fear Preventing Participation Scores	2.29 units on a scale STANDARD_DEVIATION .78 • n=5 Participants	2.35 units on a scale STANDARD_DEVIATION 1.09 • n=7 Participants	2.32 units on a scale STANDARD_DEVIATION .93 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=19 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Knowledge Scores at 1 Week	35.32 units on a scale Standard Error 1.00	36.93 units on a scale Standard Error .94

PRIMARY outcome

Timeframe: 1 week

Youth will be asked to respond to 6 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). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=22 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Attitudes Scores at 1 Week	3.92 units on a scale Standard Error .09	3.87 units on a scale Standard Error .09

PRIMARY outcome

Timeframe: 1 week

Youth will be asked to respond to 5 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). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=22 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Beliefs Scores at 1 Week	4.40 units on a scale Standard Error .09	4.23 units on a scale Standard Error .09

PRIMARY outcome

Timeframe: 1 week

Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for 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; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=22 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Self-Efficacy to Communicate Scores at 1 Week	4.59 units on a scale Standard Error .10	4.48 units on a scale Standard Error .10

PRIMARY outcome

Timeframe: 1 week

Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=22 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Self-Efficacy to Gather Information Scores at 1 Week	4.33 units on a scale Standard Error .09	4.38 units on a scale Standard Error .09

PRIMARY outcome

Timeframe: 1 week

Youth will be asked to respond to 3 questions 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). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=22 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Confidence Scores at 1 Week	3.91 units on a scale Standard Error .14	3.73 units on a scale Standard Error .14

PRIMARY outcome

Timeframe: 1 week

Youth 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 to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=22 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Procedural Fears Scores at 1 Week	2.25 units on a scale Standard Error .10	2.24 units on a scale Standard Error .10

PRIMARY outcome

Timeframe: 1 week

Population: In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.

Youth 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; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=21 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=19 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Likelihood of Participation Scores at 1 Week	3.63 units on a scale Standard Error .15	3.65 units on a scale Standard Error .15

PRIMARY outcome

Timeframe: 1 week

Population: In this study, participants were able to skip questions in the questionnaires. Thus, there may not be complete data for all participants for this outcome.

Youth 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; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.

Outcome measures

Outcome measures
Measure	Educational Website Intervention n=21 Participants The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials. DigiKnowIt News: Teen: Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.	Wait-list Control n=20 Participants The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).
Fear Preventing Participation Scores at 1 Week	2.13 units on a scale Standard Error .18	2.40 units on a scale Standard Error .18

Adverse Events

Educational Website Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Wait-list Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alison Parker

innovation Research & Training

Phone: 919-493-7700

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place