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Interactive Technology for Media Literacy Drug Prevention in Community Groups

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REAL media curriculum
Sponsored by
Real Prevention, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rutgers, The State University of New Jersey

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

REAL media

Programming as usual

Arm Description

Participants in this group will be assigned to use the REAL media curriculum.

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.

Outcomes

Primary Outcome Measures

Change in 15-item Intentions to Use Substances Measure
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 15-item Intentions to Use Substances Measure
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 5-item Lifetime Substance Use Measure
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 5-item Lifetime Substance Use Measure
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 5-item Frequency of Substance Use Measure
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 5-item Frequency of Substance Use Measure
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.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2017
Last Updated
February 6, 2021
Sponsor
Real Prevention, LLC
Collaborators
Rutgers University, University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT03157700
Brief Title
Interactive Technology for Media Literacy Drug Prevention in Community Groups
Official Title
Interactive Technology for Media Literacy Drug Prevention in Community Groups
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 8, 2018 (Actual)
Primary Completion Date
August 22, 2019 (Actual)
Study Completion Date
August 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Prevention, LLC
Collaborators
Rutgers University, University of Missouri-Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Factorial design in which participants are randomly assigned to treatment and control groups. The control is a delayed intervention condition, receiving the intervention after the treatment condition is completed.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
642 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REAL media
Arm Type
Experimental
Arm Description
Participants in this group will be assigned to use the REAL media curriculum.
Arm Title
Programming as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
REAL media curriculum
Intervention Description
REAL media is a 5-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth substance use.
Primary Outcome Measure Information:
Title
Change in 15-item Intentions to Use Substances Measure
Description
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.
Time Frame
Change in intentions to use within the next month from baseline to 3 months post baseline.
Title
Change in 15-item Intentions to Use Substances Measure
Description
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.
Time Frame
Change in intentions to use within the next month from baseline to 9 months post baseline.
Title
Change in 5-item Lifetime Substance Use Measure
Description
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.
Time Frame
Change in lifetime (e.g., ever tried) use from baseline to 3 months post baseline.
Title
Change in 5-item Lifetime Substance Use Measure
Description
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.
Time Frame
Change in lifetime (e.g., ever tried) use from baseline to 9 months post baseline.
Title
Change in 5-item Frequency of Substance Use Measure
Description
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.
Time Frame
Change in frequency of use from baseline to 3 months post baseline.
Title
Change in 5-item Frequency of Substance Use Measure
Description
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.
Time Frame
Change in frequency of use from baseline to 9 months post baseline.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hecht, Ph.D.
Organizational Affiliation
Real Prevention, LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn Greene, Ph.D.
Organizational Affiliation
Rutgers University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers, The State University of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be shared.
IPD Sharing Time Frame
Once study is completed and publications submitted.
Citations:
PubMed Identifier
33140287
Citation
Greene K, Choi HJ, Glenn SD, Ray AE, Hecht ML. The Role of Engagement in Effective, Digital Prevention Interventions: the Function of Engagement in the REAL Media Substance Use Prevention Curriculum. Prev Sci. 2021 Feb;22(2):247-258. doi: 10.1007/s11121-020-01181-9. Epub 2020 Nov 3.
Results Reference
derived
PubMed Identifier
32693198
Citation
Greene K, Ray AE, Choi HJ, Glenn SD, Lyons RE, Hecht ML. Short term effects of the REAL media e-learning media literacy substance prevention curriculum: An RCT of adolescents disseminated through a community organization. Drug Alcohol Depend. 2020 Sep 1;214:108170. doi: 10.1016/j.drugalcdep.2020.108170. Epub 2020 Jul 10.
Results Reference
derived

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Interactive Technology for Media Literacy Drug Prevention in Community Groups

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