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Peer-to-peer Tobacco and ENDS Prevention (PPSM)

Primary Purpose

Substance Use

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REAL media Plus curriculum
Sponsored by
Real Prevention, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use

Eligibility Criteria

13 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • REAL Prevention LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

REAL media Plus

programming as usual

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 2, 2018
Last Updated
September 9, 2019
Sponsor
Real Prevention, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03491865
Brief Title
Peer-to-peer Tobacco and ENDS Prevention
Acronym
PPSM
Official Title
Peer-to-peer Social Media Diffusion of Tobacco and ENDS Use Prevention Messages
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Withdrawn
Why Stopped
unfunded
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Prevention, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REAL media Plus
Arm Type
Experimental
Arm Description
Participants in this group will be assigned to use the REAL media Plus curriculum.
Arm Title
programming as usual
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
REAL media Plus curriculum
Intervention Description
REAL media Plus is a 7-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth smoking and vaping use.
Primary Outcome Measure Information:
Title
Smoking and Vaping Use
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Hecht, PhD
Organizational Affiliation
Real Prevention, LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
REAL Prevention LLC
City
Clifton
State/Province
New Jersey
ZIP/Postal Code
07013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Peer-to-peer Tobacco and ENDS Prevention

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