- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04919590
Text Message Quit Vaping Intervention for Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Director of Research, Innovations
- Phone Number: 202-525-6473
- Email: vapestudy@truthinitiative.org
Study Locations
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20001
- Truth Initiative
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 13-17
- Past 30-day use of e-cigarettes containing nicotine
- Interest in quitting e-cigarette use in the next 30 days
- US residence
Exclusion Criteria:
- Failure to confirm mobile number after initial sign-up
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: This is Quitting
Participants will be enrolled to receive messages from This is Quitting. Users receive one age-appropriate message per day tailored to their enrollment date or quit date, which can be set and reset via text message. Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for a week preceding it and 8 weeks afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting, and cutting down to quit. Keywords COPE, STRESS, SLIP, and MORE provide on-demand support. |
Text message-based intervention for quit vaping support.
|
Other: Assessment only control
After an initial enrollment message, participants will be contacted monthly to assess e-cigarette use.
At the end of the study data collection period, they will receive information on how to sign up for This is Quitting if they are interested in the program.
|
Assessment only
|
Other: Waitlist control
After an initial enrollment message, participants will receive no contact from study staff except for 1-month and 7-month follow-up assessments.
At the end of the study data collection period, they will receive information on how to sign up for This is Quitting if they are interested in the program.
|
No contact until follow-up survey, waitlisted to receive intervention post study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported 30-day Point Prevalence Abstinence
Time Frame: 7 months post enrollment
|
In the past 30 days, did you vape at all, even a puff of someone else's?
|
7 months post enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
30-day Point Prevalence Abstinence
Time Frame: 1 month post enrollment
|
In the past 30 days, did you vape at all, even a puff of someone else's?
|
1 month post enrollment
|
Number of Quit Attempts
Time Frame: 1 and 7 months post enrollment
|
Since you joined the study a month ago/In the last 6 months, how many times have you stopped vaping - not even a puff - for one day or longer because you were trying to quit for good?
|
1 and 7 months post enrollment
|
Changes in Daily E-cigarette Use Frequency
Time Frame: 1 and 7 months post enrollment
|
On average, how many puffs/hits on your vape do you take on a typical day?
|
1 and 7 months post enrollment
|
Changes in Confidence in Quitting E-cigarettes
Time Frame: 1 and 7 months post enrollment
|
How confident are you that you can quit vaping?
Response on a scale of 1-5
|
1 and 7 months post enrollment
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TruthInitiativeQVSTeen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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