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The goal of this study is to evaluate the effectiveness of DigiKnowIt News: Teen with parent-adolescent pairs.
Parent-adolescent pairs (N=180) will be recruited to participate in a randomized controlled trial. Parent consent and parent permission and youth assent will be sought. Participant pairs 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 and parents 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 the intervention group will include Consumer Satisfaction Questions). Youth and parents in the wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After one week, they will be asked to complete a Consumer Satisfaction Questionnaire.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational website intervention | Experimental | Participants will have access to an intervention between pre-test and post-test assessments. The intervention, DigiKnowIt News: Teen, is an educational website designed to teach youth (12-17 years) about pediatric clinical trials and give parents and youth resources for communication and shared decision-making about research. |
|
| Wait-List Control | No Intervention | Participants will not have access to the educational website between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DigiKnowIt News: Teen | Behavioral | Participants will interact with a multimedia educational website that will teach them about pediatric clinical trials, including topics such as participant rights and safety and different types of procedures used in trials, and will provide strategies for parent-teen shared decision-making about clinical trials. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Adolescents' Knowledge About Clinical Trials at Week 1 | Adolescents will respond to 27 questions that assess their factual knowledge about clinical research (e.g., Which is true of a behavioral treatment 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Attitudes About Clinical Trials at Week 1 | 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). 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Beliefs About Clinical Trials at Week 1 | 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). 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Self-efficacy to Communicate at Week 1 | Adolescents will be 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.) 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alison Parker, PhD | Innovation Research & Training | Principal Investigator |
| Tracy Scull, PhD | Innovation Research & Training | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| innovation Research & Training | Durham | North Carolina | 27713 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37391773 | Derived | Parker AE, Scull TM, Kennedy KL. Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial. Trials. 2023 Jun 30;24(1):436. doi: 10.1186/s13063-023-07464-0. |
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Of 255 enrolled parent-adolescent pairs, 233 met inclusion criteria and were randomized to condition (interview or wait-list control).
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| ID | Title | Description |
|---|---|---|
| FG000 | Educational Website Intervention | Participants will have access to an intervention between pre-test and post-test assessments. The intervention, DigiKnowIt News: Teen, is an educational website designed to teach youth (12-17 years) about pediatric clinical trials and give parents and youth resources for communication and shared decision-making about research. DigiKnowIt News: Teen: Participants will interact with a multimedia educational website that will teach them about pediatric clinical trials, including topics such as participant rights and safety and different types of procedures used in trials, and will provide strategies for parent-teen shared decision-making about clinical trials. |
| FG001 | Wait-List Control | Participants will not have access to the educational website between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Educational Website Intervention | Participants will have access to an intervention between pre-test and post-test assessments. The intervention, DigiKnowIt News: Teen, is an educational website designed to teach youth (12-17 years) about pediatric clinical trials and give parents and youth resources for communication and shared decision-making about research. DigiKnowIt News: Teen: Participants will interact with a multimedia educational website that will teach them about pediatric clinical trials, including topics such as participant rights and safety and different types of procedures used in trials, and will provide strategies for parent-teen shared decision-making about clinical trials. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The overall sample includes parents and adolescents. The analysis population for adolescent age includes just adolescents and the analysis population for parent age includes just parents. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Adolescents' Knowledge About Clinical Trials at Week 1 | Adolescents will respond to 27 questions that assess their factual knowledge about clinical research (e.g., Which is true of a behavioral treatment 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
|
From baseline to end of intervention at 1 week
The participants in the study completed web-based questionnaires and utilized an educational website (if in the intervention group). The risks associated with this study were minimal and the participants were not at risk for mortality as a function of participating in this study. Because this study investigated an online behavioral intervention, All-Cause Mortality was not monitored or assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Educational Website Intervention | Participants will have access to an intervention between pre-test and post-test assessments. The intervention, DigiKnowIt News: Teen, is an educational website designed to teach youth (12-17 years) about pediatric clinical trials and give parents and youth resources for communication and shared decision-making about research. DigiKnowIt News: Teen: Participants will interact with a multimedia educational website that will teach them about pediatric clinical trials, including topics such as participant rights and safety and different types of procedures used in trials, and will provide strategies for parent-teen shared decision-making about clinical trials. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alison Parker | innovation Research & Training | 919-493-7700 | aparker@irtinc.us |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 24, 2023 | Jun 21, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Baseline and Week 1 |
| Change From Baseline in Adolescents' Self-efficacy to Gather Information at Week 1 | 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.) 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 1 | Adolescents will be asked to respond to 3 questions about their confidence in participating 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). 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Procedural Fears at Week 1 | 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 (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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Likelihood of Participation at Week 1 | 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?; 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 1 | 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?; 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Familiarity With Clinical Trials at Week 1 | 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Willingness to Participate at Week 1 | 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. | Baseline and Week 1 |
| Change From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 1 | 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; 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. | Baseline and Week 1 |
| Change From Baseline in Parents' Attitudes About Clinical Trials at Week 1 | 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. | Baseline and Week 1 |
| Change From Baseline in Parents' Beliefs About Clinical Trials at Week 1 | 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. | Baseline and Week 1 |
| Change From Baseline in Parents' Likelihood of Participation at Week 1 | 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?; 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. | Baseline and Week 1 |
| Change From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 1 | 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?; 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. | Baseline and Week 1 |
| Change From Baseline in Parents' Familiarity With Clinical Trials at Week 1 | 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. | Baseline and Week 1 |
| Change From Baseline in Parents' Willingness to Participate at Week 1 | Parents will review five 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. | Baseline and Week 1 |
| Change From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 1 | Parents will be asked to respond to 16 questions regarding their perceptions of the quality of communication with their adolescent (If my child were in trouble, she/he could tell me; 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. | Baseline and Week 1 |
| BG001 | Wait-List Control | Participants will not have access to the educational website between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen). |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
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| Sex/Gender, Customized | The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents. | Count of Participants | Participants |
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| Race (NIH/OMB) | The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Wait-List Control | Participants will not have access to the educational website between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen). |
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| Primary | Change From Baseline in Adolescents' Attitudes About Clinical Trials at Week 1 | 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). 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Beliefs About Clinical Trials at Week 1 | 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). 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Self-efficacy to Communicate at Week 1 | Adolescents will be 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.) 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Self-efficacy to Gather Information at Week 1 | 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.) 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 1 | Adolescents will be asked to respond to 3 questions about their confidence in participating 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). 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Procedural Fears at Week 1 | 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 (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 discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Likelihood of Participation at Week 1 | 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?; 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 1 | 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?; 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Familiarity With Clinical Trials at Week 1 | 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Willingness to Participate at Week 1 | 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 1 | 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; 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Parents' Attitudes About Clinical Trials at Week 1 | 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Parents' Beliefs About Clinical Trials at Week 1 | 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Parents' Likelihood of Participation at Week 1 | 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?; 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 1 | 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?; 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Parents' Familiarity With Clinical Trials at Week 1 | 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Parents' Willingness to Participate at Week 1 | Parents will review five 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| Primary | Change From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 1 | Parents will be asked to respond to 16 questions regarding their perceptions of the quality of communication with their adolescent (If my child were in trouble, she/he could tell me; 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. | The discrepancy between the overall number of participants analyzed and participant flow is due to imputation. Demographic variables were not imputed so if a participant was missing demographic data, they were not included in the outcome analyses. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 1 |
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| 0 |
| 0 |
| 0 |
| 166 |
| 0 |
| 166 |
| EG001 | Wait-List Control | Participants will not have access to the educational website between the pre-test and post-test assessments. After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen). | 0 | 0 | 0 | 192 | 0 | 192 |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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