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OpenTrials
Completed

NCT Number: NCT03531866

Evaluation Study of Web-based Resource for Youth

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).

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Key information

Conditions

Chronic Disease Disease Attributes Healthy Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

innovation Research & Training

Durham, North Carolina, 27713, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DigiKnowIt News

Behavioral

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Innovation Research & Training

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Web-based Resource for Youth About Clinical Research

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 22, 2018
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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