- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04899999
Graphic Messages to Prevent E-Cigarette Use Among Black and Latino Adolescents
February 7, 2022 updated by: Francisco Cartujano, MD, University of Rochester
Graphic Messages to Prevent E-Cigarette Use Among Latino and African American Adolescents: A Randomized Controlled Trial
The aim of this study is to determine if graphic messages prevent future vaping use among African American and Latino adolescents.
The images have been developed in a user-design model and include four main themes: health reward, financial reward, self-efficacy, and social norms.
We will assess pre- and post-exposure reactions on likelihood of future vaping among African American and Latino adolescents.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
362
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Rochester, New York, United States, 14642
- University of Rochester Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 17 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- self-identify as African American/Black and/or Hispanic/Latino
- know how to read and speak English and/or Spanish
- have never used e-cigarettes
- have access to a device that will be able to connect to the online survey
Exclusion Criteria:
- not identifying as African American/Black and/or Hispanic/Latino
- using e-cigarettes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Financial reward graphic message
|
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference.
Image includes the following text: Vaping leads to nothing.
Don't let your money vaporize away.
|
EXPERIMENTAL: Health reward graphic message
|
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference.
Image includes the following text: Dying for a vape?
It hurts more than you know.
|
EXPERIMENTAL: Self-efficacy graphic message
|
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference.
Image includes the following text: Vaping companies are targeting Black and Latino teens.
Your life matters.
Don't let them take it away.
|
EXPERIMENTAL: Social norms graphic message
|
Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference.
Image includes the following text: Just because vaping is common, doesn't mean it's cool.
Stay woke.
Don't smoke.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in percent of participants who are not susceptible to future vaping
Time Frame: baseline to post intervention, approximately 1 day
|
Participants will be asked three questions.
(1) Are you curious about using e-cigarettes (vaping)?; (2) Do you think that you will use e-cigarettes (vaping) in the next 12 months?; and (3) If one of your best friends were to offer you an e-cigarette, would you use it?
Responses include 1= definitely not, 2= probably not, 3= probably yes, 4= definitely yes.
Participants who answer "Definitely not" to all three questions will be categorized as not susceptible.
|
baseline to post intervention, approximately 1 day
|
Mean change in susceptibility score
Time Frame: baseline to post intervention, approximately 1 day
|
Participants will be asked three questions.
(1) Are you curious about using e-cigarettes (vaping)?; (2) Do you think that you will use e-cigarettes (vaping) in the next 12 months?; and (3) If one of your best friends were to offer you an e-cigarette, would you use it?
Responses include 1= definitely not, 2= probably not, 3= probably yes, 4= definitely yes.
The scores for each question will be summed per participant and the mean change calculated comparing baseline to post intervention.
|
baseline to post intervention, approximately 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 6, 2021
Primary Completion (ACTUAL)
December 15, 2021
Study Completion (ACTUAL)
December 15, 2021
Study Registration Dates
First Submitted
May 19, 2021
First Submitted That Met QC Criteria
May 19, 2021
First Posted (ACTUAL)
May 25, 2021
Study Record Updates
Last Update Posted (ACTUAL)
February 24, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00006267
- U54CA228110 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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