Evaluation Study of Web-based Resource for Youth

Innovation Research & Training

Status: Completed

Conditions: Healthy; Chronic Disease

Treatments: Behavioral: DigiKnowIt News

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03531866

HHSN268201700010C

Details and patient eligibility

About

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).

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 8 to 14 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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91 participants in 3 patient groups

Intervention Version A

Experimental group

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.

Treatment:

Behavioral: DigiKnowIt News

Intervention Version B

Experimental group

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).

Treatment:

Behavioral: DigiKnowIt News

Wait-List Control

No Intervention group

Description:

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