Clinical trial NCT03157700: 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
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Lead sponsor: Real Prevention, LLC
Sponsor class: INDUSTRY
Collaborators: name: Rutgers University
name: University of Missouri-Columbia
First posted: 2017-05-17
Enrollment: 642
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change in 15-item Intentions to Use Substances Measure
timeFrame: Change in intentions to use within the next month from baseline to 3 months post baseline.
measure: Change in 15-item Intentions to Use Substances Measure
timeFrame: Change in intentions to use within the next month from baseline to 9 months post baseline.
measure: Change in 5-item Lifetime Substance Use Measure
timeFrame: Change in lifetime (e.g., ever tried) use from baseline to 3 months post baseline.
measure: Change in 5-item Lifetime Substance Use Measure
timeFrame: Change in lifetime (e.g., ever tried) use from baseline to 9 months post baseline.
measure: Change in 5-item Frequency of Substance Use Measure
timeFrame: Change in frequency of use from baseline to 3 months post baseline.
measure: Change in 5-item Frequency of Substance Use Measure
timeFrame: Change in frequency of use from baseline to 9 months post baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers, The State University of New Jersey
state: New Jersey
Study officials:
affiliation: Real Prevention, LLC
name: Michael Hecht, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Kathryn Greene, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.