Evaluation Study of Web-based Resource for Youth

Study Overview
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Brief Summary
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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
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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.

Official Title
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Web-based Resource for Youth About Clinical Research

Conditions
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Chronic Disease, Healthy

Intervention / Treatment
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* Behavioral: DigiKnowIt News


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Version A<br>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<br>* 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.<br>|
| Experimental: Intervention Version B<br>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<br>* 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.<br>|
| No Intervention: Wait-List Control<br>Youth will not have access to DigiKnowIt News until after the post-test timepoint. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge about Clinical Research | Questions will assess youth's factual knowledge about clinical research using a multiple choice format. | 2 weeks | 
| Change in Attitudes toward Clinical Research | 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 | 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 | Questions will assess youth's initiative-taking using a 5-point Likert scale. | 2 weeks | 
| Changes in Hope | Questions will assess youth's perceptions of hope using a 6-point Likert scale. | 2 weeks | 
| 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. | 2 weeks | 
| Consumer Satisfaction | Questions will ask youth to reflect on their experiences with the web-based resource using 5-point Likert scales. | 1 day |