Text Message Quit Vaping Intervention for Adolescents

Study Overview
=================
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).

Official Title
-----------------
Text Message Quit Vaping Intervention for Adolescents

Conditions
-----------------
Vaping, Cessation, Tobacco

Intervention / Treatment
-----------------
* Behavioral: This is Quitting
* Other: Assessment only control
* Other: Waitlist control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: This is Quitting<br>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. | Behavioral: This is Quitting<br>* Text message-based intervention for quit vaping support.<br>|
| Other: Assessment only control<br>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. | Other: Assessment only control<br>* Assessment only<br>|
| Other: Waitlist control<br>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. | Other: Waitlist control<br>* No contact until follow-up survey, waitlisted to receive intervention post study<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day Point Prevalence Abstinence | In the past 30 days, did you vape at all, even a puff of someone else's? | 7 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day Point Prevalence Abstinence | 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 | 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 | 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 | How confident are you that you can quit vaping? Response on a scale of 1-5 | 1 and 7 months post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vaping cessation, Mobile intervention, Adolescents