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Clinical Trials/NCT03531866
NCT03531866
Completed
Not Applicable

Web-based Resource for Youth About Clinical Research

Innovation Research & Training1 site in 1 country91 target enrollmentMay 24, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Disease
Sponsor
Innovation Research & Training
Enrollment
91
Locations
1
Primary Endpoint
Change in Attitudes toward Clinical Research
Status
Completed
Last Updated
7 years ago

Overview

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).

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.

Registry
clinicaltrials.gov
Start Date
May 24, 2018
End Date
August 17, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Innovation Research & Training
Responsible Party
Principal Investigator
Principal Investigator

Alison Parker

Research Scientist II

Innovation Research & Training

Eligibility 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.

Outcomes

Primary Outcomes

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.

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.

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.

Secondary Outcomes

  • Changes in Initiative-Taking(2 weeks)
  • Consumer Satisfaction(1 day)
  • Changes in Hope(2 weeks)
  • Changes in Parent-Child Communication(2 weeks)

Study Sites (1)

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