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Web-based Resource for Children and Adolescents About Clinical Research

NCT ID: NCT04448210

Last Updated: 2020-12-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-30

Study Completion Date

2020-08-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Chronic Illnesses, Multiple

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Participants

Study Groups

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Educational website intervention

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

Group Type EXPERIMENTAL

DigiKnowIt News: Teen

Intervention Type BEHAVIORAL

Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.

Wait-list control

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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DigiKnowIt News: Teen

Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Innovation Research & Training

OTHER

Sponsor Role lead

Responsible Party

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Alison Parker

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Parker, PhD

Role: PRINCIPAL_INVESTIGATOR

Innovation Research & Training

Locations

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innovation Research & Training

Durham, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

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R44NR019565

Identifier Type: NIH

Identifier Source: org_study_id

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