Trial Outcomes & Findings for Website for Adolescents About Pediatric Clinical Trials (NCT NCT05714943)
NCT ID: NCT05714943
Last Updated: 2024-06-27
Results Overview
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.
COMPLETED
NA
255 participants
Baseline and Week 1
2024-06-27
Participant Flow
Of 255 enrolled parent-adolescent pairs, 233 met inclusion criteria and were randomized to condition (interview or wait-list control).
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
236
|
230
|
|
Overall Study
Completed Pretest
|
166
|
192
|
|
Overall Study
COMPLETED
|
138
|
188
|
|
Overall Study
NOT COMPLETED
|
98
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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.
Baseline characteristics by cohort
| Measure |
Educational Website Intervention
n=166 Participants
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.
|
Wait-List Control
n=192 Participants
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).
|
Total
n=358 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Adolescent
|
14.60 years
STANDARD_DEVIATION 1.75 • n=83 Participants • 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.
|
14.53 years
STANDARD_DEVIATION 1.52 • n=96 Participants • 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.
|
14.56 years
STANDARD_DEVIATION 1.63 • n=179 Participants • 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.
|
|
Age, Continuous
Parent
|
45.85 years
STANDARD_DEVIATION 7.04 • n=82 Participants • 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.
|
44.08 years
STANDARD_DEVIATION 6.40 • n=96 Participants • 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.
|
44.90 years
STANDARD_DEVIATION 6.74 • n=178 Participants • 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.
|
|
Sex/Gender, Customized
Adolescent Male
|
34 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
39 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
73 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Sex/Gender, Customized
Adolescent Female
|
48 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
53 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
101 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Sex/Gender, Customized
Adolescent Non-Binary
|
1 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
4 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
5 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Sex/Gender, Customized
Parent Male
|
9 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
9 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
18 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Sex/Gender, Customized
Parent Female
|
74 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
87 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
161 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent sex/gender categories only include adolescents and the parent sex/gender categories only include parents.
|
|
Ethnicity (NIH/OMB)
Adolescent · Hispanic or Latino
|
21 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
24 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
45 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Adolescent · Not Hispanic or Latino
|
62 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
72 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
134 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Adolescent · Unknown or Not Reported
|
0 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
0 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
0 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Parent · Hispanic or Latino
|
16 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
16 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
32 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Parent · Not Hispanic or Latino
|
67 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
80 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
147 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Ethnicity (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
0 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
0 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent ethnicity categories include only adolescents and the parent ethnicity categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · American Indian or Alaska Native
|
0 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Asian
|
2 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
4 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Black or African American
|
9 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
15 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
24 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · White
|
59 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
65 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
124 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · More than one race
|
12 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
12 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
24 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Adolescent · Unknown or Not Reported
|
1 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · American Indian or Alaska Native
|
1 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
1 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
2 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Asian
|
4 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
3 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
7 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Black or African American
|
10 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
15 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
25 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · White
|
63 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
72 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
135 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · More than one race
|
5 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
5 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
10 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Race (NIH/OMB)
Parent · Unknown or Not Reported
|
0 Participants
n=83 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=96 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
0 Participants
n=179 Participants • The overall sample includes parents and adolescents. The adolescent race categories include only adolescents and the parent race categories include only parents.
|
|
Region of Enrollment
United States
|
166 participants
n=166 Participants
|
192 participants
n=192 Participants
|
358 participants
n=358 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Knowledge About Clinical Trials at Week 1
|
40.32 units on a scale
Standard Error .66
|
40.33 units on a scale
Standard Error .57
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Attitudes About Clinical Trials at Week 1
|
3.91 units on a scale
Standard Error .07
|
3.65 units on a scale
Standard Error .05
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Beliefs About Clinical Trials at Week 1
|
4.19 units on a scale
Standard Error .07
|
4.05 units on a scale
Standard Error .05
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Self-efficacy to Communicate at Week 1
|
4.44 units on a scale
Standard Error .07
|
4.39 units on a scale
Standard Error .06
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Self-efficacy to Gather Information at Week 1
|
4.15 units on a scale
Standard Error .08
|
4.25 units on a scale
Standard Error .06
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 1
|
3.76 units on a scale
Standard Error .08
|
3.33 units on a scale
Standard Error .07
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Procedural Fears at Week 1
|
2.42 units on a scale
Standard Error .09
|
2.42 units on a scale
Standard Error .07
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Likelihood of Participation at Week 1
|
3.64 units on a scale
Standard Error .10
|
3.48 units on a scale
Standard Error .08
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 1
|
2.71 units on a scale
Standard Error .14
|
2.51 units on a scale
Standard Error .11
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Familiarity With Clinical Trials at Week 1
|
2.80 units on a scale
Standard Error .11
|
2.23 units on a scale
Standard Error .09
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Willingness to Participate at Week 1
|
4.45 units on a scale
Standard Error .17
|
4.41 units on a scale
Standard Error .12
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 1
|
3.33 units on a scale
Standard Error .04
|
3.29 units on a scale
Standard Error .04
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Parents' Attitudes About Clinical Trials at Week 1
|
3.88 units on a scale
Standard Error .06
|
3.69 units on a scale
Standard Error .05
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Parents' Beliefs About Clinical Trials at Week 1
|
4.18 units on a scale
Standard Error .05
|
4.05 units on a scale
Standard Error .05
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Parents' Likelihood of Participation at Week 1
|
3.80 units on a scale
Standard Error .09
|
3.61 units on a scale
Standard Error .07
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 1
|
2.57 units on a scale
Standard Error .15
|
2.92 units on a scale
Standard Error .11
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Parents' Familiarity With Clinical Trials at Week 1
|
2.89 units on a scale
Standard Error .12
|
2.31 units on a scale
Standard Error .09
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Parents' Willingness to Participate at Week 1
|
4.60 units on a scale
Standard Error .10
|
4.62 units on a scale
Standard Error .10
|
PRIMARY outcome
Timeframe: Baseline and Week 1Population: 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.
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.
Outcome measures
| Measure |
Educational Website Intervention
n=82 Participants
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.
|
Wait-List Control
n=93 Participants
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).
|
|---|---|---|
|
Change From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 1
|
3.15 units on a scale
Standard Error .03
|
3.15 units on a scale
Standard Error .03
|
Adverse Events
Educational Website Intervention
Wait-List Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place