NCT03531866

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

May 24, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2018

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

May 7, 2018

Last Update Submit

April 29, 2019

Conditions

Chronic DiseaseHealthy

Outcome Measures

Primary Outcomes (3)

  • Change in Knowledge about Clinical Research

    Questions will assess youth's factual knowledge about clinical research using a multiple choice format.

    2 weeks

  • 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

  • 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 Outcomes (4)

  • Changes in Initiative-Taking

    2 weeks

  • Changes in Hope

    2 weeks

  • Changes in Parent-Child Communication

    2 weeks

  • Consumer Satisfaction

    1 day

Study Arms (3)

Intervention Version A

EXPERIMENTAL

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.

Behavioral: DigiKnowIt News

Intervention Version B

EXPERIMENTAL

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).

Behavioral: DigiKnowIt News

Wait-List Control

NO INTERVENTION

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

Interventions

DigiKnowIt NewsBEHAVIORAL

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.

Intervention Version AIntervention Version B

Eligibility Criteria

Age8 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Within the ages of 8 and 14 years of age

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

innovation Research & Training

Durham, North Carolina, 27713, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alison Parker, PhD

    Innovation Research & Training

    PRINCIPAL INVESTIGATOR

  • Tracy Scull, PhD

    Innovation Research & Training

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist II

Study Record Dates

First Submitted

May 7, 2018

First Posted

May 22, 2018

Study Start

May 24, 2018

Primary Completion

August 17, 2018

Study Completion

August 17, 2018

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)