Evaluation Study of Web-based Resource for Youth

Not Applicable

Completed

• Conditions: Chronic Disease; Healthy
• Interventions: Behavioral: DigiKnowIt News

• Registration Number: NCT03531866
• Lead Sponsor: Innovation Research & Training

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.

Study Timeline

• Study First Submitted: 2018-05-07
• Study First Submitted QC: 2018-05-18
• Study First Posted: 2018-05-22
• Study Start: 2018-05-24
• Primary Completion: 2018-08-17
• Study Completion: 2018-08-17
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-29
• Last Update Posted: 2019-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Version A	DigiKnowIt News	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.
Intervention Version B	DigiKnowIt News	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).

Primary Outcome Measures

Name	Time	Method
Change in Attitudes toward Clinical Research	2 weeks	Questions will assess youth's attitudes toward pediatric clinical research on a 3-point Likert rating scale.
Change in Self-Efficacy for Making Decisions	2 weeks	Questions will assess youth's self-efficacy for making decisions using a 5-point Likert scale.
Change in Knowledge about Clinical Research	2 weeks	Questions will assess youth's factual knowledge about clinical research using a multiple choice format.

Secondary Outcome Measures

Name	Time	Method
Changes in Initiative-Taking	2 weeks	Questions will assess youth's initiative-taking using a 5-point Likert scale.
Consumer Satisfaction	1 day	Questions will ask youth to reflect on their experiences with the web-based resource using 5-point Likert scales.
Changes in Hope	2 weeks	Questions will assess youth's perceptions of hope using a 6-point Likert scale.
Changes in Parent-Child Communication	2 weeks	Questions will assess youth's perceptions about the quality of communication in their parent-child relationship using a 5-point Likert scale.

Trial Locations

Locations (1)

innovation Research & Training; 🇺🇸 Durham, North Carolina, United States