Web-based Resource for Children and Adolescents About Clinical Research

NCT04448210 | Completed Results

• 1 other identifier: R44NR019565
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aims of this project are to: 1) create a developmentally appropriate interactive educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.

Conditions

Healthy; Chronic Illnesses, Multiple

Outcome Measures

Primary Outcomes (9)

• Knowledge Scores at 1 Week

  Youth will respond to 25 questions that assess their factual knowledge about clinical research (e.g., Who is part of a clinical trial?). Questions are in multiple choice format and some questions have multiple correct answers. The correct responses were summed across the questions. The range of scores is from 0 to 46. Higher scores indicate more knowledge about clinical research.

  1 week

• Attitudes Scores at 1 Week

  Youth will be asked to respond to 6 questions that assess their positive attitudes about clinical trials (e.g., How do you feel about kids participating in clinical trials?; 1=Not good at all; 2=Not very good; 3=Not sure; 4=Good; 5=Very good). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive attitudes toward clinical trials.

  1 week

• Beliefs Scores at 1 Week

  Youth will be asked to respond to 5 questions that assess their beliefs about positive aspects of pediatric clinical research (e.g., I believe that clinical trials can help kids; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more positive beliefs about clinical research.

  1 week

• Self-Efficacy to Communicate Scores at 1 Week

  Youth will be asked to respond to 10 questions related to their self-efficacy for making decisions related to participation in clinical trials for communicating about clinical trials (e.g., Tell the researcher that I don't want to participate in the clinical trial, even if they really want me to do it; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy about communicating about clinical trials.

  1 week

• Self-Efficacy to Gather Information Scores at 1 Week

  Youth will be asked to respond to 9 questions related to their self-efficacy for making decisions related to participation in clinical trials for gathering information about clinical trials (e.g., How sure are you that you can do the following things: Ask my parents questions for more information about clinical trials?; 1 = I cannot do it at all; 5 = I know I can do it.). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more self-efficacy for gathering information about clinical trials.

  1 week

• Confidence Scores at 1 Week

  Youth will be asked to respond to 3 questions to measure youths' confidence for participating clinical trials (e.g., I know what rights I have in a clinical trial. I know whom to ask if I need more information about a clinical trial.; 1=Strongly Disagree; 2=Disagree; 3=Unsure; 4=Agree; 5=Strongly Agree). Responses to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more confidence for participating in clinical trials.

  1 week

• Procedural Fears Scores at 1 Week

  Youth 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, on a 5-point Likert scale (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 to this scale were averaged and the minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate more fears about medical procedures.

  1 week

• Likelihood of Participation Scores at 1 Week

  Youth 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?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of participating in a clinical trial.

  1 week

• Fear Preventing Participation Scores at 1 Week

  Youth 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?) using a 5-point Likert scale (1 = Not likely; 5 = Extremely likely). The minimum scale score was 1 and the maximum scale score was 5. Higher scores indicate increased likelihood of fear preventing them from participating in a clinical trial.

  1 week

Study Arms (2)

Educational website intervention

EXPERIMENTAL

The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.

Behavioral: DigiKnowIt News: Teen

Wait-list control

NO INTERVENTION

The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).

Interventions

DigiKnowIt News: Teen BEHAVIORAL

Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.

Educational website intervention

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants must be between the ages of 12 and 17 years.
• Participants must have access to a computer or tablet with Internet connection.
• Participants must be able to read and write in English fluently.

You may not qualify if:

• Participants must NOT have previously participated in a clinical trial.

Sponsors & Collaborators

• Innovation Research & Training: lead

Study Sites (1)

innovation Research & Training

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Multiple Chronic Conditions

Condition Hierarchy (Ancestors)

Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Alison Parker
• Organization: innovation Research & Training

aparker@irtinc.us

919-493-7700

Study Officials

• Alison Parker, PhD

  Innovation Research & Training

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: June 22, 2020
• First Posted: June 25, 2020
• Study Start: June 30, 2020
• Primary Completion: July 19, 2020
• Study Completion: August 2, 2020
• Last Updated: December 19, 2020
• Results First Posted: December 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)