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Website for Adolescents About Pediatric Clinical Trials

Web-based Resource for Children and Adolescents About Clinical Research

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05714943
Enrollment
255
Registered
2023-02-06
Start date
2023-07-07
Completion date
2023-08-31
Last updated
2024-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Illnesses, Multiple, Healthy

Brief summary

The goal of this study is to evaluate the effectiveness of DigiKnowIt News: Teen with parent-adolescent pairs.

Detailed description

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.

Interventions

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.

Sponsors

Innovation Research & Training
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Adult participant is a parent or legal guardian of adolescent participant; * Adolescent participant is within the ages of 12-17 years; * Parent-adolescent pair has access to a computer or tablet with internet connection * Parent-adolescent pair is fluent in English

Exclusion criteria

* Adolescent participant has previously participated in a clinical trial after kindergarten.

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline in Adolescents' Knowledge About Clinical Trials at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Attitudes About Clinical Trials at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Beliefs About Clinical Trials at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Self-efficacy to Communicate at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Self-efficacy to Gather Information at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Procedural Fears at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Likelihood of Participation at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Familiarity With Clinical Trials at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Willingness to Participate at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 1Baseline and Week 1Adolescents 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.
Change From Baseline in Parents' Attitudes About Clinical Trials at Week 1Baseline and Week 1Parents 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.
Change From Baseline in Parents' Beliefs About Clinical Trials at Week 1Baseline and Week 1Parents 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.
Change From Baseline in Parents' Likelihood of Participation at Week 1Baseline and Week 1Parents 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.
Change From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 1Baseline and Week 1Parents 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.
Change From Baseline in Parents' Familiarity With Clinical Trials at Week 1Baseline and Week 1Parents 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.
Change From Baseline in Parents' Willingness to Participate at Week 1Baseline and Week 1Parents 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.
Change From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 1Baseline and Week 1Parents 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.

Countries

United States

Participant flow

Pre-assignment details

Of 255 enrolled parent-adolescent pairs, 233 met inclusion criteria and were randomized to condition (interview or wait-list control).

Participants by arm

ArmCount
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.
166
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).
192
Total358

Baseline characteristics

CharacteristicEducational Website InterventionWait-List ControlTotal
Age, Continuous
Adolescent
14.60 years
STANDARD_DEVIATION 1.75
14.53 years
STANDARD_DEVIATION 1.52
14.56 years
STANDARD_DEVIATION 1.63
Age, Continuous
Parent
45.85 years
STANDARD_DEVIATION 7.04
44.08 years
STANDARD_DEVIATION 6.4
44.90 years
STANDARD_DEVIATION 6.74
Ethnicity (NIH/OMB)
Adolescent
Hispanic or Latino
21 Participants24 Participants45 Participants
Ethnicity (NIH/OMB)
Adolescent
Not Hispanic or Latino
62 Participants72 Participants134 Participants
Ethnicity (NIH/OMB)
Adolescent
Unknown or Not Reported
0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Parent
Hispanic or Latino
16 Participants16 Participants32 Participants
Ethnicity (NIH/OMB)
Parent
Not Hispanic or Latino
67 Participants80 Participants147 Participants
Ethnicity (NIH/OMB)
Parent
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Adolescent
Asian
2 Participants2 Participants4 Participants
Race (NIH/OMB)
Adolescent
Black or African American
9 Participants15 Participants24 Participants
Race (NIH/OMB)
Adolescent
More than one race
12 Participants12 Participants24 Participants
Race (NIH/OMB)
Adolescent
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Adolescent
Unknown or Not Reported
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Adolescent
White
59 Participants65 Participants124 Participants
Race (NIH/OMB)
Parent
American Indian or Alaska Native
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Parent
Asian
4 Participants3 Participants7 Participants
Race (NIH/OMB)
Parent
Black or African American
10 Participants15 Participants25 Participants
Race (NIH/OMB)
Parent
More than one race
5 Participants5 Participants10 Participants
Race (NIH/OMB)
Parent
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Parent
White
63 Participants72 Participants135 Participants
Region of Enrollment
United States
166 participants192 participants358 participants
Sex/Gender, Customized
Adolescent Female
48 Participants53 Participants101 Participants
Sex/Gender, Customized
Adolescent Male
34 Participants39 Participants73 Participants
Sex/Gender, Customized
Adolescent Non-Binary
1 Participants4 Participants5 Participants
Sex/Gender, Customized
Parent Female
74 Participants87 Participants161 Participants
Sex/Gender, Customized
Parent Male
9 Participants9 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 1660 / 192
serious
Total, serious adverse events
0 / 1660 / 192

Outcome results

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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Attitudes About Clinical Trials at Week 13.91 units on a scaleStandard Error 0.07
Wait-List ControlChange From Baseline in Adolescents' Attitudes About Clinical Trials at Week 13.65 units on a scaleStandard Error 0.05
p-value: 0Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Beliefs About Clinical Trials at Week 14.19 units on a scaleStandard Error 0.07
Wait-List ControlChange From Baseline in Adolescents' Beliefs About Clinical Trials at Week 14.05 units on a scaleStandard Error 0.05
p-value: 0.09Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 13.76 units on a scaleStandard Error 0.08
Wait-List ControlChange From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 13.33 units on a scaleStandard Error 0.07
p-value: 0Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Familiarity With Clinical Trials at Week 12.80 units on a scaleStandard Error 0.11
Wait-List ControlChange From Baseline in Adolescents' Familiarity With Clinical Trials at Week 12.23 units on a scaleStandard Error 0.09
p-value: 0Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Knowledge About Clinical Trials at Week 140.32 units on a scaleStandard Error 0.66
Wait-List ControlChange From Baseline in Adolescents' Knowledge About Clinical Trials at Week 140.33 units on a scaleStandard Error 0.57
p-value: 0.99Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 12.71 units on a scaleStandard Error 0.14
Wait-List ControlChange From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 12.51 units on a scaleStandard Error 0.11
p-value: 0.27Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Likelihood of Participation at Week 13.64 units on a scaleStandard Error 0.1
Wait-List ControlChange From Baseline in Adolescents' Likelihood of Participation at Week 13.48 units on a scaleStandard Error 0.08
p-value: 0.21Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 13.33 units on a scaleStandard Error 0.04
Wait-List ControlChange From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 13.29 units on a scaleStandard Error 0.04
p-value: 0.61Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Procedural Fears at Week 12.42 units on a scaleStandard Error 0.09
Wait-List ControlChange From Baseline in Adolescents' Procedural Fears at Week 12.42 units on a scaleStandard Error 0.07
p-value: 0.97Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Self-efficacy to Communicate at Week 14.44 units on a scaleStandard Error 0.07
Wait-List ControlChange From Baseline in Adolescents' Self-efficacy to Communicate at Week 14.39 units on a scaleStandard Error 0.06
p-value: 0.57Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Self-efficacy to Gather Information at Week 14.15 units on a scaleStandard Error 0.08
Wait-List ControlChange From Baseline in Adolescents' Self-efficacy to Gather Information at Week 14.25 units on a scaleStandard Error 0.06
p-value: 0.32Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Adolescents' Willingness to Participate at Week 14.45 units on a scaleStandard Error 0.17
Wait-List ControlChange From Baseline in Adolescents' Willingness to Participate at Week 14.41 units on a scaleStandard Error 0.12
p-value: 0.86Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Parents' Attitudes About Clinical Trials at Week 13.88 units on a scaleStandard Error 0.06
Wait-List ControlChange From Baseline in Parents' Attitudes About Clinical Trials at Week 13.69 units on a scaleStandard Error 0.05
p-value: 0.02Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Parents' Beliefs About Clinical Trials at Week 14.18 units on a scaleStandard Error 0.05
Wait-List ControlChange From Baseline in Parents' Beliefs About Clinical Trials at Week 14.05 units on a scaleStandard Error 0.05
p-value: 0.08Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Parents' Familiarity With Clinical Trials at Week 12.89 units on a scaleStandard Error 0.12
Wait-List ControlChange From Baseline in Parents' Familiarity With Clinical Trials at Week 12.31 units on a scaleStandard Error 0.09
p-value: 0Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 12.57 units on a scaleStandard Error 0.15
Wait-List ControlChange From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 12.92 units on a scaleStandard Error 0.11
p-value: 0.06Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Parents' Likelihood of Participation at Week 13.80 units on a scaleStandard Error 0.09
Wait-List ControlChange From Baseline in Parents' Likelihood of Participation at Week 13.61 units on a scaleStandard Error 0.07
p-value: 0.08Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 13.15 units on a scaleStandard Error 0.03
Wait-List ControlChange From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 13.15 units on a scaleStandard Error 0.03
p-value: 0.94Regression, Linear
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.

Time frame: Baseline and Week 1

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Educational Website InterventionChange From Baseline in Parents' Willingness to Participate at Week 14.60 units on a scaleStandard Error 0.1
Wait-List ControlChange From Baseline in Parents' Willingness to Participate at Week 14.62 units on a scaleStandard Error 0.1
p-value: 0.88Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026