A Youth-Brief Tobacco Intervention (Y-BTI) for High School Youth

Study Overview
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Brief Summary
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Tobacco use is increasing among youth in the U.S. However evidence for the long-term effectiveness of tobacco cessation programs for youth is limited. The current study seeks to adapt and evaluate a universal group-based Youth Brief Tobacco Intervention (Y-BTI) plus mobile phone automated text messaging (ATM) for 9th grade students. This study will use a sequential, multi-method research design beginning with qualitative roundtable discussions with 9th grade students to adapt the existing young adult Brief Tobacco Intervention (BTI) for youth. Roundtable discussions with students will identify salient intervention themes and strategies for targeting the Y-BTI intervention and developing the text messages. The second phase of the study evaluates the Y-BTI and ATM through a cluster randomized controlled trial that compares 4 treatment combinations: (1) Y-BTI + ATM, (2) Y-BTI alone, (3) ATM alone, or (4) no treatment control. It is hypothesized that the Y-BTI + ATM will produce greater abstinence at the 6-month follow-up compared to the Y-BTI alone, ATM alone or no treatment control. Further, it is hypothesized that the Y-BTI alone and ATM alone will produce greater abstinence at the 6-month follow-up compared to the no treatment control. Roughly 90% of daily smokers started before the age of 18, and 2,000 youth smoke a cigarette for the first time each day in the U.S. Additionally, e-cigarette use is on the rise among youth, and is linked to cigarette initiation among tobacco naïve youth. In order to curb the rise of tobacco use among youth, interventions that are easily implemented and easily disseminated need to be developed for youth addressing currently available products and contemporary patterns of use. If the interventions in the current study are proven efficacious, they can easily be disseminated to other schools to continue reducing youth tobacco use.

Official Title
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Testing an Anti-Tobacco Intervention to Reduce Tobacco and Nicotine Use Among High School Students

Conditions
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Tobacco Use Cessation, Tobacco Use, Electronic Cigarette Use

Intervention / Treatment
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* Behavioral: Youth Brief Tobacco Intervention
* Behavioral: Automated Text Messaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Enrolled in the selected physical education or health class selected for participation in the study. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Youth Brief Tobacco Intervention + Automated Text Messaging<br> | Behavioral: Youth Brief Tobacco Intervention<br>* The universal prevention program was designed as a group intervention to include components of effective tobacco control programs for youth and young adults. The intervention lasts approximately 45 minutes and is delivered in a classroom setting, utilizing a Socratic teaching style and evoking participation using the principles of motivational interviewing. The Y-BTI targets all tobacco products with the goals to enhance motivation for youth to quit tobacco or remain tobacco-free, reduce intentions to use tobacco, promote peer discussions around the impact of using tobacco, and correct cognitive misperceptions around tobacco use.<br>Behavioral: Automated Text Messaging<br>* The ATM intervention is automated because all messages are pre-written, and their timing is pre-planned. Therefore, all students will receive the same content at the same time. The ATM intervention will last four weeks, with three - five messages sent per week. The automated program will include a mix of static and responsive messages. Specifically, some messages will be designed to maintain or enhance knowledge about tobacco use by providing facts to the student, for example, listing the negative health effects of tobacco use. Other messages will promote engagement and reflection from the student. To promote refection, some messages will request a response, but in a way that maintains confidentiality. To ensure confidential information is not sent to the text messaging program, messages that need a response will include the appropriate replies, while reflection questions will be left open-ended.<br>|
| Experimental: Youth Brief Tobacco Intervention<br> | Behavioral: Youth Brief Tobacco Intervention<br>* The universal prevention program was designed as a group intervention to include components of effective tobacco control programs for youth and young adults. The intervention lasts approximately 45 minutes and is delivered in a classroom setting, utilizing a Socratic teaching style and evoking participation using the principles of motivational interviewing. The Y-BTI targets all tobacco products with the goals to enhance motivation for youth to quit tobacco or remain tobacco-free, reduce intentions to use tobacco, promote peer discussions around the impact of using tobacco, and correct cognitive misperceptions around tobacco use.<br>|
| Experimental: Automated Text Messaging<br> | Behavioral: Automated Text Messaging<br>* The ATM intervention is automated because all messages are pre-written, and their timing is pre-planned. Therefore, all students will receive the same content at the same time. The ATM intervention will last four weeks, with three - five messages sent per week. The automated program will include a mix of static and responsive messages. Specifically, some messages will be designed to maintain or enhance knowledge about tobacco use by providing facts to the student, for example, listing the negative health effects of tobacco use. Other messages will promote engagement and reflection from the student. To promote refection, some messages will request a response, but in a way that maintains confidentiality. To ensure confidential information is not sent to the text messaging program, messages that need a response will include the appropriate replies, while reflection questions will be left open-ended.<br>|
| No Intervention: No Treatment Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Past 30-day point prevalence abstinence | The primary outcome measure in this study is self-reported past 30-day abstinence from cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, and pipe tobacco. Past 30-day abstinence will be determined for each product by a No response to the question, In the past 30 days, have you used a <insert tobacco product name>, even one or two times or puffs? | past 30-day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Past 7-day point prevalence abstinence | The primary outcome measure in this study is self-reported past 7-day abstinence from cigarettes, e-cigarettes, smokeless tobacco, hookah, cigars, little cigars, cigarillos, and pipe tobacco. Past 7-day abstinence will be determined for each product by a No response to the question, In the past 7days, have you used a <insert tobacco product name>, even one or two times or puffs? | past 7 days |