Little 2022.

Study name	Rationale, design, and methods for the development of a youth adapted Brief Tobacco Intervention plus automated text messaging for high school students
Methods	Study aim: To develop and pilot test a universal group‐based Youth Brief Tobacco Intervention (Y‐BTI) plus mobile phone automated text messaging (ATM) for 9th grade students to both prevent initiation amongst non‐users and promote cessation amongst current‐users Study design: Cluster‐randomised controlled trial
Participants	Setting: School Type of participants: 9th grade students Age range of participants (if children or adolescents): 14 to 15 years Region: Virginia, USA
Interventions	Number of experimental conditions: 4 (3 intervention, 1 control) Type of intervention: Prevention and cessation Description of intervention: Intervention: Youth Brief Tobacco Intervention. The universal prevention programme was designed as a group intervention to include components of effective tobacco control programmes for youth and young adults. The intervention lasts approximately 45 minutes and is delivered in a classroom setting, utilising 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. Intervention: Automated Text Messaging. 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 4 weeks, with 3 to 5 messages sent per week. The automated programme 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. Intervention: Youth Brief Tobacco Intervention + Automated Text Messaging Comparator: No‐treatment control
Outcomes	Primary: Outcomes relating to the prevention or cessation of child and adolescent e‐cigarette use Past 30‐day point prevalence abstinence at 28‐week follow‐up. The primary outcome measure in this study is self‐reported past 30‐day abstinence from e‐cigarettes. Secondary: Outcomes relating to child and adolescent use of tobacco Past 30‐day point prevalence abstinence at 28‐week follow‐up. 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. Secondary: Outcomes relating to unintended adverse consequences of the intervention Not reported
Starting date	First posted: 31 May 2022 Estimated study completion date: 30 June 2024
Contact information	Melissa A Little; mal7uj@virginia.edu
Notes	DOI: 10.1016/j.cct.2022.106840 Data availability: The review team contacted the corresponding author to obtain available data to include in the review. The author indicated that no data were currently available.