NCT03491865

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

2.7 years

First QC Date

April 2, 2018

Last Update Submit

September 9, 2019

Conditions

Substance Use

Outcome Measures

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.

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

Study Arms (2)

REAL media Plus

EXPERIMENTAL

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

Behavioral: REAL media Plus curriculum

programming as usual

NO INTERVENTION

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

REAL media Plus curriculumBEHAVIORAL

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

REAL media Plus

Eligibility Criteria

Age13 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

REAL Prevention LLC

Clifton, New Jersey, 07013, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Michael Hecht, PhD

    Real Prevention, LLC

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 9, 2018

Study Start

September 1, 2018

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

September 11, 2019

Record last verified: 2019-09

Locations

US(1)