Cessation, Tobacco, Vaping
Conditions
Keywords
Vaping cessation, Mobile intervention, Adolescents
Brief summary
This research study, conducted by Truth Initiative, will help us learn how text messaging can help adolescents between 13 and 17 years of age quit vaping.
Detailed description
The Teen Quit Vaping Study (QVS Teen) is a comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 13-17. This study is a 3-arm randomized controlled trial conducted among young users aged 13-17 recruited through online channels. Participants will be randomized to a quit vaping text message intervention, an assessment-only control condition, or a waitlist control condition. The primary aim is to examine 30-day point prevalence abstinence at 7-months post enrollment (roughly corresponds to 6-months post-treatment).
Interventions
BEHAVIORALThis is Quitting
Text message-based intervention for quit vaping support.
Assessment only
OTHERWaitlist control
No contact until follow-up survey, waitlisted to receive intervention post study
Sponsors
Truth Initiative
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants are not explicitly told they are in the control group, although they may deduce their assignment from presence or lack of regular text message intervention. Research staff doing data collection will not be aware of the random assignments and all participants will receive the same follow-up assessments regardless of assignment.
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day Point Prevalence Abstinence | 7 months post enrollment | In the past 30 days, did you vape at all, even a puff of someone else's? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
This is Quitting: Text message-based intervention for quit vaping support. | 759 |
| 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 control: Assessment only | 744 |
| Waitlist Control After an initial enrollment message, participants will be contacted only for data collection at 1 and 7 months post enrollment. 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.
Waitlist only | 178 |
| Total | 1,681 |
Baseline characteristics
| Characteristic | This is Quitting | Assessment Only Control | Waitlist Control | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 759 Participants | 744 Participants | 178 Participants | 1681 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 16.4 years STANDARD_DEVIATION 0.8 | 16.4 years STANDARD_DEVIATION 0.8 | 16.4 years STANDARD_DEVIATION 0.8 | 16.4 years STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 7 Participants | 3 Participants | 21 Participants |
| Race (NIH/OMB) Asian | 16 Participants | 20 Participants | 4 Participants | 40 Participants |
| Race (NIH/OMB) Black or African American | 76 Participants | 76 Participants | 15 Participants | 167 Participants |
| Race (NIH/OMB) More than one race | 139 Participants | 136 Participants | 26 Participants | 301 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 45 Participants | 42 Participants | 12 Participants | 99 Participants |
| Race (NIH/OMB) White | 469 Participants | 461 Participants | 117 Participants | 1047 Participants |
| Region of Enrollment United States | 759 participants | 744 participants | 178 participants | 1681 participants |
| Sex/Gender, Customized Gender Female | 386 Participants | 369 Participants | 93 Participants | 848 Participants |
| Sex/Gender, Customized Gender Male | 314 Participants | 314 Participants | 69 Participants | 697 Participants |
| Sex/Gender, Customized Gender Non-binary or Other | 51 Participants | 59 Participants | 16 Participants | 126 Participants |
| Sex/Gender, Customized Gender Unknown or not reported | 8 Participants | 2 Participants | 0 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 759 | 0 / 744 | 0 / 178 |
| other Total, other adverse events | 0 / 759 | 0 / 744 | 0 / 178 |
| serious Total, serious adverse events | 0 / 759 | 0 / 744 | 0 / 178 |
Outcome results
Primary
Self-reported 30-day Point Prevalence Abstinence
In the past 30 days, did you vape at all, even a puff of someone else's?
Time frame: 7 months post enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| This is Quitting | Self-reported 30-day Point Prevalence Abstinence | 287 Participants |
| Assessment Only Control | Self-reported 30-day Point Prevalence Abstinence | 208 Participants |
| Waitlist Control | Self-reported 30-day Point Prevalence Abstinence | 49 Participants |