Substance UseNCT03157700

Interactive Technology for Media Literacy Drug Prevention in Community Groups

A study testing REAL media curriculum in people with Substance Use, run by Real Prevention, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 13 years and olderHealthy volunteers can take part
Conditions the study is for: Substance Use
What is being tested?: REAL media curriculum
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 642 participants
Where: 1 siteUnited States
Study dates: 8 Aug 2018to 22 Aug 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 13 years and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rutgers, The State University of New Jersey
New Brunswick, New Jersey, 08901

Other trials in United States

About this study

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.

Read the 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.

Conditions: Substance Use
Being tested: REAL media curriculum
Medical subject headings: Substance-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03157700
Study group	Role	What they receive
REAL media	Experimental	Participants in this group will be assigned to use the REAL media curriculum. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change in frequency of use from baseline to 9 months post baseline.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Aug 201822 Aug 2019

First posted17 May 2017
Study start8 Aug 2018
Primary completion22 Aug 2019
Study completion22 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Substance UseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
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)
Enrolment: 642 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03157700
Sponsor's protocol ID: 2R42DA039595-02A1
Status last verified: Feb 2021
First submitted: 27 Apr 2017
Last updated: 9 Feb 2021
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data will be shared.

Publications

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.
PubMed 33140287
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.
PubMed 32693198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interactive Technology for Media Literacy Drug Prevention in Community Groups
ClinicalTrials.gov ID: NCT03157700
Acronym / sponsor ID: 2R42DA039595-02A1
Conditions: Substance Use
Study type: Interventional
Recruitment status: Completed
Enrolment: 642 participants (actual)
Lead sponsor: Real Prevention, LLCIndustry (pharma, biotech, devices)
Collaborators: Rutgers University, University of Missouri-Columbia
Study start: 8 Aug 2018 (actual)
Primary completion: 22 Aug 2019 (actual)
Study completion: 22 Aug 2019 (actual)
First posted: 17 May 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
REAL media	Experimental	Behavioral: REAL media curriculumParticipants in this group will be assigned to use the 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.

Who may qualify

Ages: 13 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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)

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

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

Primary outcome

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 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 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 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 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 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
Derived from this study: PubMed 33140287Greene 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.
Derived from this study: PubMed 32693198Greene 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.
Individual participant dataSharing planned: Yes. De-identified data will be shared.

Related trials for Substance Use

RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Recruiting
Tdcs And cogNitive traininG cOmbined for AUD (TANGO)
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Not yet recruitingPhase 1
Phase I Trial of High-Density Theta Burst Stimulation (hdTBS)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael Hecht, Ph.D. principal investigator

Real Prevention, LLC

Kathryn Greene, Ph.D. principal investigator

Rutgers University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing REAL media curriculum in people with Substance Use, run by Real Prevention, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03157700, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.