Website for Adolescents About Pediatric Clinical Trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

Web-based Resource for Children and Adolescents About Clinical Research

ClinicalTrials.gov ID

NCT05714943

Acronym / sponsor ID

Teensinresearch-SBIR-22-002

Conditions

Healthy, Chronic Illnesses, Multiple

Study type

Interventional

Recruitment status

Completed

Enrolment

255 participants (actual)

Lead sponsor

Innovation Research & TrainingUniversity, hospital or other

Study start

7 Jul 2023 (actual)

Primary completion

31 Aug 2023 (actual)

Study completion

31 Aug 2023 (actual)

First posted

6 Feb 2023 (actual)

Results

Posted 27 Jun 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Health services research

Allocation

Randomised

Intervention model

Parallel groups

Masking

Single blind (participant)

Number of arms

2

Who may qualify

Ages

12 to 17 years

Sex

All

Healthy volunteers

Accepted

Age groups

Child

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. Change From Baseline in Adolescents' Knowledge About Clinical Trials at Week 1

   Time frame: Baseline and 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.

2. Change From Baseline in Adolescents' Attitudes About Clinical Trials at Week 1

   Time frame: Baseline and 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.

3. 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.

4. Change From Baseline in Adolescents' Self-efficacy to Communicate at Week 1

   Time frame: Baseline and 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.

5. Change From Baseline in Adolescents' Self-efficacy to Gather Information at Week 1

   Time frame: Baseline and 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.

6. Change From Baseline in Adolescents' Confidence for Participating in a Clinical Trial at Week 1

   Time frame: Baseline and 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.

7. Change From Baseline in Adolescents' Procedural Fears at Week 1

   Time frame: Baseline and 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.

8. Change From Baseline in Adolescents' Likelihood of Participation at Week 1

   Time frame: Baseline and 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.

9. Change From Baseline in Adolescents' Likelihood of Fear Preventing Participation at Week 1

   Time frame: Baseline and 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.

10. Change From Baseline in Adolescents' Familiarity With Clinical Trials at Week 1

    Time frame: Baseline and 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.

11. Change From Baseline in Adolescents' Willingness to Participate at Week 1

    Time frame: Baseline and 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.

12. Change From Baseline in Adolescents' Perceptions of Parent-adolescent Communication Quality at Week 1

    Time frame: Baseline and 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.

13. Change From Baseline in Parents' Attitudes About Clinical Trials at Week 1

    Time frame: Baseline and 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.

14. 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.

15. Change From Baseline in Parents' Likelihood of Participation at Week 1

    Time frame: Baseline and 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.

16. Change From Baseline in Parents' Likelihood of Fear Preventing Participation at Week 1

    Time frame: Baseline and 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.

17. 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.

18. Change From Baseline in Parents' Willingness to Participate at Week 1

    Time frame: Baseline and 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.

19. Change From Baseline in Parents' Perceptions of Parent-adolescent Communication Quality at Week 1

    Time frame: Baseline and 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• Derived from this study: PubMed 37391773Parker AE, Scull TM, Kennedy KL. Efficacy of DigiKnowItNews: Teen, a multimedia educational website for adolescents about pediatric clinical trials: study protocol for a randomized controlled trial. Trials. 2023 Jun 30;24(1):436. doi: 10.1186/s13063-023-07464-0.
• Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

1 site in 1 country: see every site and its status.