Peer-to-peer Tobacco and ENDS Prevention (PPSM)
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|ClinicalTrials.gov Identifier: NCT03491865|
Recruitment Status : Withdrawn (unfunded)
First Posted : April 9, 2018
Last Update Posted : September 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Substance Use||Behavioral: REAL media Plus curriculum||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peer-to-peer Social Media Diffusion of Tobacco and ENDS Use Prevention Messages|
|Estimated Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||May 31, 2021|
|Estimated Study Completion Date :||May 31, 2021|
Experimental: REAL media Plus
Participants in this group will be assigned to use the REAL media Plus curriculum.
Behavioral: REAL 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.
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491865
|United States, New Jersey|
|REAL Prevention LLC|
|Clifton, New Jersey, United States, 07013|
|Principal Investigator:||Michael Hecht, PhD||Real Prevention, LLC|