Evaluation Study of Web-based Resource for Youth

April 29, 2019 updated by: Alison Parker, Innovation Research & Training

Web-based Resource for Youth About Clinical Research

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

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

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27713
        • innovation Research & Training

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

8 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks
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.
2 weeks
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.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Initiative-Taking
Time Frame: 2 weeks
Questions will assess youth's initiative-taking using a 5-point Likert scale.
2 weeks
Changes in Hope
Time Frame: 2 weeks
Questions will assess youth's perceptions of hope using a 6-point Likert scale.
2 weeks
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.
2 weeks
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.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Innovation Research & Training

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

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)

May 24, 2018

Primary Completion (Actual)

August 17, 2018

Study Completion (Actual)

August 17, 2018

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

May 18, 2018

First Posted (Actual)

May 22, 2018

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHSN268201700010C

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.

Clinical Trials on Healthy

Clinical Trials on DigiKnowIt News

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe