Interactive Technology for Media Literacy Drug Prevention in Community Groups

February 6, 2021 updated by: Real Prevention, LLC
This Phase II STTR will evaluate an interactive, self-paced, e-learning media literacy intervention, REAL media, to prevent youth substance use among youth in the 4-H organization. Participating 4-H clubs will be randomly assigned to use the curriculum or continue current practices with the option for delivery at the end of the study. 4-H members (ages 13-15) will complete a pretest, immediate posttest and follow-up posttests at 3 and 9 months to assess effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

REAL media is an interactive, self-paced, e-learning media literacy curriculum that prevents adolescent substance use among 13-15-year-old teens. The program consists of 5 levels. Levels 1 to 4 are 15-25 minutes; level 5 allots time for message production done offline. Activities lead students to engage in critique and analysis of arguments present/absent from pro-ATOD and other popular product messages and to begin the process of refuting and counter-arguing these messages. These skills are reinforced in level 5 using an active involvement strategy in which youth plan and produce anti-ATOD messages. Users first plan their message via an online worksheet, which requires engagement with and application of media literacy concepts rather than focus exclusively on technology and/or production features. Next, participants design their posters/videos and upload their messages to a social media site as part of a contest, where they recruit peers and family to like or comment on their message.

Study Type

Interventional

Enrollment (Actual)

642

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers, The State University of New Jersey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 4-H members and leaders must belong to a participating club in Pennsylvania, Ohio, New Jersey, West Virginia, or Maryland
  • members must be between the ages of 13-15
  • club leaders must be at least 21 years of age
  • written parental consent and assent from members
  • written consent from club leaders (online assent)

Exclusion Criteria:

  • the inability to speak or read American English
  • access to and the ability to use a computer, or navigate the Internet
  • for youth, lack of parental consent/youth assent/leader consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REAL media
Participants in this group will be assigned to use the REAL media curriculum.
Behavioral: REAL media curriculum
REAL media is a 5-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth substance use.
No Intervention: Programming as usual
Participants in this group will participate in 4-H programming as usual. They will have the opportunity to use the REAL media curriculum at the conclusion of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 15-item Intentions to Use Substances Measure
Time Frame: Change in intentions to use within the next month from baseline to 3 months post baseline.
Self reported likelihood of using alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana in the following scenarios: at a party, while hanging out with friends, and while by yourself. Response options include Definitely no, No, Yes, and Definitely Yes.
Change in intentions to use within the next month from baseline to 3 months post baseline.
Change in 15-item Intentions to Use Substances Measure
Time Frame: Change in intentions to use within the next month from baseline to 9 months post baseline.
Self reported likelihood of using alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana in the following scenarios: at a party, while hanging out with friends, and while by yourself. Response options include Definitely no, No, Yes, and Definitely Yes.
Change in intentions to use within the next month from baseline to 9 months post baseline.
Change in 5-item Lifetime Substance Use Measure
Time Frame: Change in lifetime (e.g., ever tried) use from baseline to 3 months post baseline.
Self reported lifetime use of (e.g., whether you ever tried) alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana. Response options include Yes and No.
Change in lifetime (e.g., ever tried) use from baseline to 3 months post baseline.
Change in 5-item Lifetime Substance Use Measure
Time Frame: Change in lifetime (e.g., ever tried) use from baseline to 9 months post baseline.
Self reported lifetime use of (e.g., whether you ever tried) alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana. Response options include Yes and No.
Change in lifetime (e.g., ever tried) use from baseline to 9 months post baseline.
Change in 5-item Frequency of Substance Use Measure
Time Frame: Change in frequency of use from baseline to 3 months post baseline.
Self reported frequency of use of alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana. Response options include range from 0 days to 30+ days.
Change in frequency of use from baseline to 3 months post baseline.
Change in 5-item Frequency of Substance Use Measure
Time Frame: Change in frequency of use from baseline to 9 months post baseline.
Self reported frequency of use of alcohol, cigarettes, chewing tobacco (or snuff, dip, snus, or dissolvable tobacco products), e-cigarettes, and marijuana. Response options include range from 0 days to 30+ days.
Change in frequency of use from baseline to 9 months post baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Real Prevention, LLC

Collaborators

University of Missouri-Columbia
Rutgers University

Investigators

  • Principal Investigator: Kathryn Greene, Ph.D., Rutgers University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2018

Primary Completion (Actual)

August 22, 2019

Study Completion (Actual)

August 22, 2019

Study Registration Dates

First Submitted

April 27, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 17, 2017

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 6, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2R42DA039595-02A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data will be shared.

IPD Sharing Time Frame

Once study is completed and publications submitted.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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