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Evaluation Study of Web-based Resource for Youth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531866
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : May 1, 2019
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Alison Parker, Innovation Research & Training

Study Description
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Brief Summary:
This study will evaluate DigiKnowIt News, a web-based resource to educate youth about pediatric clinical research. Youth will be randomly assigned to one of three groups (1. Intervention Version A; 2) Intervention Version B; 3) Wait-list control).

Condition or disease Intervention/treatment Phase
Chronic Disease Healthy Behavioral: DigiKnowIt News Not Applicable

Detailed Description:
Compared to the high numbers of clinical trials with adults, there are far fewer clinical trials with children and adolescents; highlighting the need for more clinical trials with pediatric populations. Lacking in the area of pediatric clinical research are resources to educate children and adolescents about clinical research in fun, interactive, and developmentally appropriate ways. Thus, a web-based resource, DigiKnowIt News, was developed for youth aged 8 to 14 years to educate youth about participating in pediatric clinical trials. The web-based resource includes video spotlights, investigations, and electronic comic books. The purpose of this study is to conduct a randomized controlled trial to determine the effectiveness of the web-based resource and examine its impact on youths' knowledge about pediatric clinical trials, self-efficacy about making decisions about participation in clinical research, and positive attitudes towards participation.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Web-based Resource for Youth About Clinical Research
Actual Study Start Date : May 24, 2018
Actual Primary Completion Date : August 17, 2018
Actual Study Completion Date : August 17, 2018
Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Version A
Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version A will include an additional topic area.
 Behavioral: DigiKnowIt News
DigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials. Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans). DigiKnowIt News is web-based and youth can complete it at home, on their own time.
Experimental: Intervention Version B
Youth will be asked to complete a version of DigiKnowIt News that includes investigations, comics, and spotlight videos that focus on four topic areas related to participating in clincial trials. Version B will include an additional topic area (different than in Version A).
 Behavioral: DigiKnowIt News
DigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials. Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans). DigiKnowIt News is web-based and youth can complete it at home, on their own time.
No Intervention: Wait-List Control
Youth will not have access to DigiKnowIt News until after the post-test timepoint.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Knowledge about Clinical Research [ Time Frame: 2 weeks ]
    Questions will assess youth's factual knowledge about clinical research using a multiple choice format.

  2. Change in Attitudes toward Clinical Research [ Time Frame: 2 weeks ]
    Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.

  3. Change in Self-Efficacy for Making Decisions [ Time Frame: 2 weeks ]
    Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.


Secondary Outcome Measures :
  1. Changes in Initiative-Taking [ Time Frame: 2 weeks ]
    Questions will assess youth's initiative-taking using a 5-point Likert scale.

  2. Changes in Hope [ Time Frame: 2 weeks ]
    Questions will assess youth's perceptions of hope using a 6-point Likert scale.

  3. Changes in Parent-Child Communication [ Time Frame: 2 weeks ]
    Questions will assess youth's perceptions about the quality of communication in their parent-child relationship using a 5-point Likert scale.

  4. Consumer Satisfaction [ Time Frame: 1 day ]
    Questions will ask youth to reflect on their experiences with the web-based resource using 5-point Likert scales.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Within the ages of 8 and 14 years of age

Exclusion Criteria:

  • Does not speak English fluently, does not have access to a computer or tablet with internet connection, and or has participated in a clinical trial after kindergarten.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531866


Locations
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United States, North Carolina
innovation Research & Training
Durham, North Carolina, United States, 27713
Sponsors and Collaborators
Innovation Research & Training
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Alison Parker, PhD Innovation Research & Training
Principal Investigator: Tracy Scull, PhD Innovation Research & Training
More Information
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Responsible Party: Alison Parker, Research Scientist II, Innovation Research & Training
ClinicalTrials.gov Identifier: NCT03531866    
Other Study ID Numbers: HHSN268201700010C
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: May 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes