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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03157700
Other study ID # 2R42DA039595-02A1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 8, 2018
Est. completion date August 22, 2019

Study information

Verified date February 2021
Source Real Prevention, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 642
Est. completion date August 22, 2019
Est. primary completion date August 22, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 13 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
REAL media curriculum
REAL media is a 5-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth substance use.

Locations

Country Name City State
United States Rutgers, The State University of New Jersey New Brunswick New Jersey

Sponsors (3)

Lead Sponsor Collaborator
Real Prevention, LLC Rutgers University, University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 intentions to use within the next month from baseline to 3 months post baseline.
Primary 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 intentions to use within the next month from baseline to 9 months post baseline.
Primary 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 lifetime (e.g., ever tried) use from baseline to 3 months post baseline.
Primary 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 lifetime (e.g., ever tried) use from baseline to 9 months post baseline.
Primary 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 frequency of use from baseline to 3 months post baseline.
Primary 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 frequency of use from baseline to 9 months post baseline.
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