Evaluation Study of Web-based Resource for Youth

Healthy Clinical Trial

Official title:

Web-based Resource for Youth About Clinical Research

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03531866
• Other study ID #: HHSN268201700010C
• Status: Completed
• Phase: N/A
• Start date: May 24, 2018
• Est. completion date: August 17, 2018

Study information

• Verified date: April 2019
• Source: Innovation Research & Training
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: August 17, 2018
• Est. primary completion date: August 17, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Disease
• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	innovation Research & Training	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Innovation Research & Training	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

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