Substance UsePPSMNCT03491865
Peer-to-peer Tobacco and ENDS Prevention
A study testing REAL media Plus curriculum in people with Substance Use, run by Real Prevention, LLC at 1 site in United States.
Trial summary
In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers. In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL media Plus on smoking and vaping. Read more about this study
- Who is it for?
- Ages 13 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- REAL media Plus curriculum
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 May 2021
- 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 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Attendance at participating schools; 9th grade student status (for student participants, both phase 1 and 2); status as a teacher/counselor (for phase 1); written parental consent and assent from students (phase 1 and 2); written consent from counselors/teachers (phase 1); and all individuals must be willing to participate.
Who cannot join
- Exclusion criteria include the inability to speak or read American English, use a computer, or navigate the Internet and, for youth, lack of parental consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peer-to-peer Social Media Diffusion of Tobacco and ENDS Use Prevention Messages
In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers.
In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL media Plus on smoking and vaping.
Read the detailed description
In Phase I, participants will participate in pilot and usability tests of the curriculum prototype. For the pilot test, teachers and students will use the curriculum prototype and then be interviewed about it. For the usability test, students and teachers will use the revised curriculum and be interviewed/complete short survey. Teachers will provide consent and students will have parental consent and their own assent.
In Phase II, a group randomized trial will be conducted during Spring semester 2020 among 9th grade student in 27 high schools in the Hillsborough County Public School system randomly assigned to treatment and control (14 treatment and 13 control). All students will complete a pretest survey. Students in two health classes in treatments schools will participate in the REAL media Plus curriculum and complete a short immediate posttest survey to rate their experience. All students will then complete two posttests. Students will have parental consent and provide their own assent.
- Conditions
- Substance Use
- Being tested
- REAL media Plus 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 Plus curriculumBehavioural
REAL media Plus is a 7-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth smoking and vaping use.
| Study group | Role | What they receive |
|---|---|---|
| REAL media Plus | Experimental | Participants in this group will be assigned to use the REAL media Plus curriculum. Receives: Behavioral: REAL media Plus curriculum |
| programming as usual | No intervention | Participants in this group will participate in their usual school curriculum. They will have the opportunity to use the REAL media Plus curriculum at the conclusion of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking and Vaping Use
Change in 5-item Lifetime Substance Use Measure Self reported lifetime use of (e.g., whether you ever tried) cigarettes and vaping. Response options include Yes and No.
Measured: Change in llifetime (e.g., ever tried) 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.
- First posted9 Apr 2018
- Study start1 Sep 2018 (estimated)
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Why it stopped: unfunded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Real Prevention, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Hecht, PhD, Principal investigator, Real Prevention, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491865
- Sponsor's protocol ID
- 284105
- Acronym
- PPSM
- Status last verified
- Sep 2019
- First submitted
- 2 Apr 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer-to-peer Social Media Diffusion of Tobacco and ENDS Use Prevention Messages
- ClinicalTrials.gov ID
- NCT03491865
- Acronym / sponsor ID
- PPSM / 284105
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unfunded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Real Prevention, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2018 (estimated)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 9 Apr 2018 (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.
In Phase I, the REAL media Plus prototype will be developed and a usability test conducted among students and teachers.
In Phase II a group randomized trial will be conducted among 27 high schools to evaluate the effects of REAL media Plus on smoking and vaping.
Detailed description
In Phase I, participants will participate in pilot and usability tests of the curriculum prototype. For the pilot test, teachers and students will use the curriculum prototype and then be interviewed about it. For the usability test, students and teachers will use the revised curriculum and be interviewed/complete short survey. Teachers will provide consent and students will have parental consent and their own assent.
In Phase II, a group randomized trial will be conducted during Spring semester 2020 among 9th grade student in 27 high schools in the Hillsborough County Public School system randomly assigned to treatment and control (14 treatment and 13 control). All students will complete a pretest survey. Students in two health classes in treatments schools will participate in the REAL media Plus curriculum and complete a short immediate posttest survey to rate their experience. All students will then complete two posttests. Students will have parental consent and provide their own assent.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REAL media Plus | Experimental | Behavioral: REAL media Plus curriculumParticipants in this group will be assigned to use the REAL media Plus curriculum. |
| programming as usual | No intervention | –Participants in this group will participate in their usual school curriculum. They will have the opportunity to use the REAL media Plus curriculum at the conclusion of the study. |
Who may qualify
- Ages
- 13 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Attendance at participating schools; 9th grade student status (for student participants, both phase 1 and 2); status as a teacher/counselor (for phase 1); written parental consent and assent from students (phase 1 and 2); written consent from counselors/teachers (phase 1); and all individuals must be willing to participate.
Key exclusion criteria (1 listed)
- Exclusion criteria include the inability to speak or read American English, use a computer, or navigate the Internet and, for youth, lack of parental 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 Plus curriculumREAL media Plus is a 7-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth smoking and vaping use. | Behavioural | REAL media Plus |
Primary outcome
Smoking and Vaping Use
Time frame: Change in llifetime (e.g., ever tried) use 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) cigarettes and vaping. Response options include Yes and No.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Individual participant dataSharing planned: Undecided
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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, PhD principal investigator
Real Prevention, LLC
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 Plus 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 11 Sep 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Smoking and Vaping Use (time frame: Change in llifetime (e.g., ever tried) use from baseline to 9 months post baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2019.