Web-based Resource for Children and Adolescents About Clinical Research

Innovation Research & Training

Status: Completed

Conditions: Healthy; Chronic Illnesses, Multiple

Treatments: Behavioral: DigiKnowIt News: Teen

Study type: Interventional

Funder types: Other

Identifiers

NCT04448210

R44NR019565

Details and patient eligibility

About

The overall aims of this project are to: 1) create a developmentally appropriate interactive educational website for adolescents called DigiKnowIt News: Teen, and 2) examine the feasibility of DigiKnowIt News: Teen in a small randomized control trial with adolescents.

Full description

Youth (N=30) will be recruited to participate in the feasibility study. Parent permission and youth assent will be sought. Participants will be randomized into one of two study arms: intervention and wait-list control. All participants will complete a web-based pre-test questionnaire. Youth in the intervention group will then receive access to DigiKnowIt News: Teen for one week. Approximately one week after completing the pre-test questionnaire, all participants will complete a web-based post-test questionnaire (the post-test for youth in the intervention group will also include Consumer Satisfaction Questions). Youth in the wait-list control group will then receive access to DigiKnowIt News: Teen for one week. After one week, they will complete a Consumer Satisfaction Questionnaire.

Enrollment: 42 patients

Sex: All

Ages: 12 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must be between the ages of 12 and 17 years.
• Participants must have access to a computer or tablet with Internet connection.
• Participants must be able to read and write in English fluently.

Exclusion criteria

• Participants must NOT have previously participated in a clinical trial.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

Educational website intervention

Experimental group

Description:

The intervention is an educational website designed to teach youth (12-17 years) about pediatric clinical trials.

Treatment:

Behavioral: DigiKnowIt News: Teen

Wait-list control

No Intervention group

Description:

The wait-list control group did not receive the intervention between the pre-test and post-test assessments. After completing the post-test questionnaire, youth in the wait-list control group had the option to receive access to the intervention (DigiKnowIt News).