ClinicalTrials.gg
WithdrawnNCT03491865PPSMUpdated Sep 11, 2019

Peer-to-peer Tobacco and ENDS Prevention

An interventional study of REAL media Plus curriculum in Substance Use, sponsored by Real Prevention, LLC. Withdrawn at 1 site in United States. Open to participants aged 13 Years to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-11.

Sponsored by Real Prevention, LLC · Not applicable, Interventional, and Prevention

Why this study was withdrawn
unfunded
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
13 Years to 16 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Substance Use
03

In context

Substance-Related Disorders

2,238 studies on the registry are indexed under Substance-Related Disorders; 409 are open to participants now.

Browse Substance-Related Disorders studies →

Lead sponsor

Real Prevention, LLC is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    REAL media Plus

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

    Behavioral: REAL media Plus curriculum

  • No intervention
    programming as usual

    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.

Interventions

  • BehavioralREAL media Plus curriculum

    REAL media Plus is a 7-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth smoking and vaping use.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change in llifetime (e.g., ever tried) use from baseline to 9 months post baseline

07

Study locations

1 site
  • REAL Prevention LLC
    Clifton, New Jersey 07013, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2018; primary completion for May 2021, 32 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Apr 9, 2018
StartEst.
Sep 1, 2018
Primary completionEst.
May 31, 2021
CompletionEst.
May 31, 2021
Last update
Sep 11, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 11, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03491865
Lead sponsor
Real Prevention, LLC
Responsible party
Sponsor
First posted
Apr 9, 2018
Start date
Sep 1, 2018 (estimated)
Primary completion
May 31, 2021 (estimated)
Completion
May 31, 2021 (estimated)
Last update
Sep 11, 2019

Study contacts

Michael Hecht, PhD
principal investigator · Real Prevention, LLC

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.

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