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Evaluation Study of Web-based Resource for Youth

Primary Purpose

Chronic Disease, Healthy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DigiKnowIt News
Sponsored by
Innovation Research & Training
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Disease

Eligibility Criteria

8 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • innovation Research & Training

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Intervention Version A

Intervention Version B

Wait-List Control

Arm Description

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.

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).

Youth will not have access to DigiKnowIt News until after the post-test timepoint.

Outcomes

Primary Outcome Measures

Change in Knowledge about Clinical Research
Questions will assess youth's factual knowledge about clinical research using a multiple choice format.
Change in Attitudes toward Clinical Research
Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.
Change in Self-Efficacy for Making Decisions
Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.

Secondary Outcome Measures

Changes in Initiative-Taking
Questions will assess youth's initiative-taking using a 5-point Likert scale.
Changes in Hope
Questions will assess youth's perceptions of hope using a 6-point Likert scale.
Changes in Parent-Child Communication
Questions will assess youth's perceptions about the quality of communication in their parent-child relationship using a 5-point Likert scale.
Consumer Satisfaction
Questions will ask youth to reflect on their experiences with the web-based resource using 5-point Likert scales.

Full Information

First Posted
May 7, 2018
Last Updated
April 29, 2019
Sponsor
Innovation Research & Training
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT03531866
Brief Title
Evaluation Study of Web-based Resource for Youth
Official Title
Web-based Resource for Youth About Clinical Research
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 24, 2018 (Actual)
Primary Completion Date
August 17, 2018 (Actual)
Study Completion Date
August 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Innovation Research & Training
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease, Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Version A
Arm Type
Experimental
Arm Description
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.
Arm Title
Intervention Version B
Arm Type
Experimental
Arm Description
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).
Arm Title
Wait-List Control
Arm Type
No Intervention
Arm Description
Youth will not have access to DigiKnowIt News until after the post-test timepoint.
Intervention Type
Behavioral
Intervention Name(s)
DigiKnowIt News
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Knowledge about Clinical Research
Description
Questions will assess youth's factual knowledge about clinical research using a multiple choice format.
Time Frame
2 weeks
Title
Change in Attitudes toward Clinical Research
Description
Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.
Time Frame
2 weeks
Title
Change in Self-Efficacy for Making Decisions
Description
Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Changes in Initiative-Taking
Description
Questions will assess youth's initiative-taking using a 5-point Likert scale.
Time Frame
2 weeks
Title
Changes in Hope
Description
Questions will assess youth's perceptions of hope using a 6-point Likert scale.
Time Frame
2 weeks
Title
Changes in Parent-Child Communication
Description
Questions will assess youth's perceptions about the quality of communication in their parent-child relationship using a 5-point Likert scale.
Time Frame
2 weeks
Title
Consumer Satisfaction
Description
Questions will ask youth to reflect on their experiences with the web-based resource using 5-point Likert scales.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison Parker, PhD
Organizational Affiliation
Innovation Research & Training
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tracy Scull, PhD
Organizational Affiliation
Innovation Research & Training
Official's Role
Principal Investigator
Facility Information:
Facility Name
innovation Research & Training
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation Study of Web-based Resource for Youth

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