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Clinical Trials/NCT03491865
NCT03491865
Withdrawn
Not Applicable

Peer-to-peer Social Media Diffusion of Tobacco and ENDS Use Prevention Messages

Real Prevention, LLC1 site in 1 countrySeptember 1, 2018
ConditionsSubstance Use

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use
Sponsor
Real Prevention, LLC
Locations
1
Primary Endpoint
Smoking and Vaping Use
Status
Withdrawn
Last Updated
6 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2018
End Date
May 31, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 include the inability to speak or read American English, use a computer, or navigate the Internet and, for youth, lack of parental consent.

Outcomes

Primary Outcomes

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.

Study Sites (1)

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