- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05714943
Website for Adolescents About Pediatric Clinical Trials
September 27, 2023 updated by: Innovation Research & Training
Web-based Resource for Children and Adolescents About Clinical Research
The goal of this study is to evaluate the effectiveness of DigiKnowIt News: Teen with parent-adolescent pairs.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
233
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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North Carolina
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Durham, North Carolina, United States, 27713
- innovation Research & Training
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
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Participants will interact with a multimedia educational website that will teach them about pediatric clinical trials, including topics such as participant rights and safety and different types of procedures used in trials, and will provide strategies for parent-teen shared decision-making about clinical trials.
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No Intervention: Wait-List Control
Participants will not have access to the educational website between the pre-test and post-test assessments.
After completing the post-test questionnaires, participants in the wait-list control group will receive access to the intervention (DigiKnowIt News: Teen).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in adolescents' knowledge about clinical trials at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' attitudes about clinical trials at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' beliefs about clinical trials at Week 1
Time Frame: Baseline and 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.
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Baseline and Week 1
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Change from baseline in adolescents' self-efficacy to communicate at Week 1
Time Frame: Baseline and Week 1
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Adolescents will be asked to respond to 10 questions about their self-efficacy for making decisions about clinical trial participation specific to communicating about clinical trials (e.g., Tell a doctor or researcher if I want to stop the clinical trial; 1 = I cannot do it at all; 5 = I know I can do it.)
Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate more self-efficacy about communication.
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Baseline and Week 1
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Change from baseline in adolescents' self-efficacy to gather information at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' confidence for participating in a clinical trial at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' procedural fears at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' likelihood of participation at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' likelihood of fear preventing participation at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' familiarity with clinical trials at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' willingness to participate at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in adolescents' perceptions of parent-adolescent communication quality at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in parents' attitudes about clinical trials at Week 1
Time Frame: Baseline and Week 1
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Parents will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about teens participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good).
Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate more positive attitudes toward clinical trials.
|
Baseline and Week 1
|
Change from baseline in parents' beliefs about clinical trials at Week 1
Time Frame: Baseline and 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.
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Baseline and Week 1
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Change from baseline in parents' likelihood of participation at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Change from baseline in parents' likelihood of fear preventing participation at Week 1
Time Frame: Baseline and Week 1
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Parents will be asked to respond to one question about the likelihood of their fear preventing them from allowing their child to participate in a clinical trial (i.e., How likely is it that your fearful or anxious feelings could stop you from allowing your child to participate in a clinical trial in the future?; 1 = Not likely; 2 = Somewhat likely; 3 = Moderately likely; 4 = Very likely; 5 = Extremely likely).
Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater likelihood of fear preventing participation in a clinical trial.
|
Baseline and Week 1
|
Change from baseline in parents' familiarity with clinical trials at Week 1
Time Frame: Baseline and Week 1
|
Parents will be asked to respond to one question about their familiarity with clinical trials [How much do you know about pediatric clinical trials (research studies with children under 18; 1 = I don't know anything; 2 = I know a little about them; 3 = I know some things about them; 4 = I know a lot about them; 5 = I know all there is to know about them].
Responses will be averaged and the minimum scale score is 1 and the maximum scale score is 5. Higher scores indicate greater familiarity with pediatric clinical trials.
|
Baseline and Week 1
|
Change from baseline in parents' willingness to participate at Week 1
Time Frame: Baseline and Week 1
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Parents will review five research protocols related to a fictitious disease ('meditis') and respond to questions about their willingness to let their child participate in each research study (i.e., "If your child had meditis, would you agree to enroll them in this study?"; 1 = Definitely not to 7 = Definitely yes).
Responses will be averaged across the five protocols and the minimum scale score is 1 and the maximum scale score is 7. Higher scores indicate greater willingness to allow their child to participate in the research studies.
|
Baseline and Week 1
|
Change from baseline in parents' perceptions of parent-adolescent communication quality at Week 1
Time Frame: Baseline and Week 1
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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.
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Baseline and Week 1
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alison Parker, PhD, innovation Research & Training
- Principal Investigator: Tracy Scull, PhD, innovation Research & Training
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 7, 2023
Primary Completion (Actual)
August 31, 2023
Study Completion (Actual)
August 31, 2023
Study Registration Dates
First Submitted
January 24, 2023
First Submitted That Met QC Criteria
January 24, 2023
First Posted (Actual)
February 6, 2023
Study Record Updates
Last Update Posted (Actual)
September 29, 2023
Last Update Submitted That Met QC Criteria
September 27, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Teensinresearch-SBIR-22-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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