Chronic Illnesses, Multiple, Healthy
Conditions
Brief summary
The overall aims of this project are to: 1) create a developmentally appropriate interactive educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.
Detailed description
Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and youth assent will be sought. Participants will be randomized into one of two study arms: intervention and wait-list control. All participants will complete a web-based pre-test questionnaire. Youth in the intervention group will then receive access to DigiKnowIt News: Teen for one week. Approximately one week after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for youth in the intervention group will also include Consumer Satisfaction Questions). Youth in the wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After one week, they will complete a Consumer Satisfaction Questionnaire.
Interventions
BEHAVIORALDigiKnowIt 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.
Sponsors
Innovation Research & Training
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be between the ages of 12 and 17 years. * Participants must have access to a computer or tablet with Internet connection. * Participants must be able to read and write in English fluently.
Exclusion criteria
* Participants must NOT have previously participated in a clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge Scores at 1 Week | 1 week | 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. |
| Attitudes Scores at 1 Week | 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. |
| Beliefs Scores at 1 Week | 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. |
| Self-Efficacy to Communicate Scores at 1 Week | 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. |
| Self-Efficacy to Gather Information Scores at 1 Week | 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. |
| Confidence Scores at 1 Week | 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. |
| Procedural Fears Scores at 1 Week | 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. |
| Likelihood of Participation Scores at 1 Week | 1 week | 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. |
| Fear Preventing Participation Scores at 1 Week | 1 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 22 |
| 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). | 20 |
| Total | 42 |
Baseline characteristics
| Characteristic | Wait-list Control | Total | Educational Website Intervention |
|---|---|---|---|
| Age, Continuous | 14.55 years STANDARD_DEVIATION 1.64 | 14.33 years STANDARD_DEVIATION 1.71 | 14.14 years STANDARD_DEVIATION 1.78 |
| Baseline Attitudes Scores | 3.85 units on a scale STANDARD_DEVIATION 0.65 | 3.80 units on a scale STANDARD_DEVIATION 0.7 | 3.76 units on a scale STANDARD_DEVIATION 0.75 |
| Baseline Beliefs Scores | 4.21 units on a scale STANDARD_DEVIATION 0.51 | 4.16 units on a scale STANDARD_DEVIATION 0.58 | 4.11 units on a scale STANDARD_DEVIATION 0.64 |
| Baseline Confidence Scores | 3.35 units on a scale STANDARD_DEVIATION 0.63 | 3.37 units on a scale STANDARD_DEVIATION 0.64 | 3.39 units on a scale STANDARD_DEVIATION 0.67 |
| Baseline Fear Preventing Participation Scores | 2.35 units on a scale STANDARD_DEVIATION 1.09 | 2.32 units on a scale STANDARD_DEVIATION 0.93 | 2.29 units on a scale STANDARD_DEVIATION 0.78 |
| Baseline Knowledge Scores | 36.25 units on a scale STANDARD_DEVIATION 4.04 | 36.00 units on a scale STANDARD_DEVIATION 4.47 | 35.74 units on a scale STANDARD_DEVIATION 4.96 |
| Baseline Likelihood of Participation Scores | 3.74 units on a scale STANDARD_DEVIATION 0.81 | 3.65 units on a scale STANDARD_DEVIATION 0.89 | 3.57 units on a scale STANDARD_DEVIATION 0.98 |
| Baseline Procedural Fears Scores | 2.46 units on a scale STANDARD_DEVIATION 0.8 | 2.37 units on a scale STANDARD_DEVIATION 0.77 | 2.28 units on a scale STANDARD_DEVIATION 0.75 |
| Baseline Self-Efficacy for Gathering Information Scores | 4.21 units on a scale STANDARD_DEVIATION 0.52 | 4.22 units on a scale STANDARD_DEVIATION 0.56 | 4.23 units on a scale STANDARD_DEVIATION 0.61 |
| Baseline Self-Efficacy to Communicate Scores | 4.56 units on a scale STANDARD_DEVIATION 0.54 | 4.52 units on a scale STANDARD_DEVIATION 0.57 | 4.49 units on a scale STANDARD_DEVIATION 0.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 8 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 34 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 7 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 12 Participants | 30 Participants | 18 Participants |
| Sex/Gender, Customized Female | 10 Participants | 20 Participants | 10 Participants |
| Sex/Gender, Customized Male | 8 Participants | 20 Participants | 12 Participants |
| Sex/Gender, Customized Non-Binary | 2 Participants | 2 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 22 | 0 / 20 |
| serious Total, serious adverse events | 0 / 22 | 0 / 20 |
Outcome results
Primary
Attitudes Scores at 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.
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Attitudes Scores at 1 Week | 3.92 units on a scale | Standard Error 0.09 |
| Wait-list Control | Attitudes Scores at 1 Week | 3.87 units on a scale | Standard Error 0.09 |
p-value: 0.72ANOVA
Primary
Beliefs Scores at 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.
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Beliefs Scores at 1 Week | 4.40 units on a scale | Standard Error 0.09 |
| Wait-list Control | Beliefs Scores at 1 Week | 4.23 units on a scale | Standard Error 0.09 |
p-value: 0.16ANOVA
Primary
Confidence Scores at 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.
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Confidence Scores at 1 Week | 3.91 units on a scale | Standard Error 0.14 |
| Wait-list Control | Confidence Scores at 1 Week | 3.73 units on a scale | Standard Error 0.14 |
p-value: 0.38ANOVA
Primary
Fear Preventing Participation Scores at 1 Week
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Fear Preventing Participation Scores at 1 Week | 2.13 units on a scale | Standard Error 0.18 |
| Wait-list Control | Fear Preventing Participation Scores at 1 Week | 2.40 units on a scale | Standard Error 0.18 |
p-value: 0.3ANOVA
Primary
Knowledge Scores at 1 Week
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Knowledge Scores at 1 Week | 35.32 units on a scale | Standard Error 1 |
| Wait-list Control | Knowledge Scores at 1 Week | 36.93 units on a scale | Standard Error 0.94 |
p-value: <0.25ANOVA
Primary
Likelihood of Participation Scores at 1 Week
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Likelihood of Participation Scores at 1 Week | 3.63 units on a scale | Standard Error 0.15 |
| Wait-list Control | Likelihood of Participation Scores at 1 Week | 3.65 units on a scale | Standard Error 0.15 |
p-value: 0.94ANOVA
Primary
Procedural Fears Scores at 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.
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Procedural Fears Scores at 1 Week | 2.25 units on a scale | Standard Error 0.1 |
| Wait-list Control | Procedural Fears Scores at 1 Week | 2.24 units on a scale | Standard Error 0.1 |
p-value: 0.94ANOVA
Primary
Self-Efficacy to Communicate Scores at 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.
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Self-Efficacy to Communicate Scores at 1 Week | 4.59 units on a scale | Standard Error 0.1 |
| Wait-list Control | Self-Efficacy to Communicate Scores at 1 Week | 4.48 units on a scale | Standard Error 0.1 |
p-value: 0.43ANOVA
Primary
Self-Efficacy to Gather Information Scores at 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.
Time frame: 1 week
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Educational Website Intervention | Self-Efficacy to Gather Information Scores at 1 Week | 4.33 units on a scale | Standard Error 0.09 |
| Wait-list Control | Self-Efficacy to Gather Information Scores at 1 Week | 4.38 units on a scale | Standard Error 0.09 |
p-value: 0.69ANOVA