Peer-to-peer Tobacco and ENDS Prevention

Substance Use Clinical Trial

— PPSM  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03491865
• Other study ID #: 284105
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2019
• Source: Real Prevention, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Use

Intervention

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.

Locations

Country	Name	City	State
United States	REAL Prevention LLC	Clifton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Real Prevention, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change in llifetime (e.g., ever tried) use from baseline to 9 months post baseline