Interactive Technology for Media Literacy Drug Prevention in Community Groups

NCT03157700 | Completed DMC

• 1 other identifier: 2R42DA039595-02A1
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (6)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (2)

REAL media

EXPERIMENTAL

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

Behavioral: REAL media curriculum

Programming as usual

NO INTERVENTION

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.

Interventions

REAL media curriculum BEHAVIORAL

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

REAL media

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Real Prevention, LLC: lead
• Rutgers University: collaborator
• University of Missouri-Columbia: collaborator

Study Sites (1)

Rutgers, The State University of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Related Publications (2)

• 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.

  PMID: 33140287 DERIVED

• 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.

  PMID: 32693198 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael Hecht, Ph.D.

  Real Prevention, LLC

  PRINCIPAL INVESTIGATOR

• Kathryn Greene, Ph.D.

  Rutgers University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 17, 2017
• Study Start: August 8, 2018
• Primary Completion: August 22, 2019
• Study Completion: August 22, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Once study is completed and publications submitted.

Locations

US (1)