This is a single-center, pragmatic, single-blind, pilot randomized controlled trial comparing the CEASE intervention to usual care (control condition). Participants will be recruited over a 9-month period and followed for 6 months (15-month study period). Figure 1 shows the study flow diagram. This study is being conducted in various clinics within the Sainte-Justine University Hospital Centre, (Montreal, Quebec, Canada), including the general pediatrics clinic, the adolescent medicine clinic, and the orthopedics and sports medicine clinics.

The recruitment target is 100 individuals who report using tobacco or e-cigarettes (either tobacco or e-cigarettes alone, or both tobacco and e-cigarettes) in the 7 days before responding to the study questionnaire. A minimum of 50 parents and 50 adolescents will be recruited.

The study will be reported according to the Strengthening the Reporting of Observational Studies in Epidemiology Statement: Guidelines for Reporting Observational Studies [26].

The appointment schedules of participating clinics will be reviewed the week before by the research team, and a recruitment schedule will be made according to the clinical volume of each clinic to maximize the number of potential patients approached. At the time of registration for their scheduled appointment, parents or legal guardians (hereafter referred to as parents) of children aged between 0 and 17 years as well as adolescents aged between 14 and 17 years are approached by a research assistant in the clinic waiting room to complete the screening survey on an electronic tablet. The survey is preceded by an abbreviated consent form. This approach is similar to that which was successfully used in CEASE studies in pediatric primary care in the United States [23]. Parents and adolescents are asked sociodemographic, smoking, and e-cigarette screening questions (see “Inclusion and Exclusion Criteria” section). Participants who respond “yes” to at least 1 of the 2 screening questions are invited to participate in the CEASE pilot study and have access to the full consent form. These forms are available in the Multimedia Appendix 1. During the entire study period, research assistants keep a detailed recruitment log, including information on participant screening, eligibility, recruitment, randomization, and retention in the study.

After consenting to the study, participants are asked to fill out a baseline questionnaire on an electronic tablet. Participants randomized to the intervention group have the option of receiving direct access to the CEASE evidence-informed cessation resources (if interested) after completing their questionnaire, while those randomized to the control group are only offered access to these resources at the end of the 6-month follow-up period (see “Control Condition” section). Participants in both groups are followed for 6 months following recruitment, with data collection at 1, 3, and 6 months (and the possibility of obtaining direct access to evidence-informed resources at each time point, if interested, for participants in the intervention group). Data collection tools (questionnaires) are available upon reasonable request to the corresponding author. Participant confidentiality is protected by limiting the collection of identifying information to an email address and phone number; date of birth, name, or participant address will not be collected. All data are stored on the secure web-based REDCap platform and in study logs on the Sainte-Justine University Hospital Centre server without participant-identifying information. Only the study investigators will have access to this data set at the end of the study period.

At each time point, participants are contacted by the study team by email, phone, or SMS text message (based on their preference) with a notification to complete the follow-up survey through REDCap, a secure web-based platform. If participants declare an abstinence of 7 days or more and consent to undergoing urine cotinine testing, they are contacted to arrange for biochemical confirmation of smoking cessation (cotinine testing) [30]. Data for confirmatory smoking or vaping cessation testing (urinary cotinine testing results) is sent directly to the study coordinator (to maintain investigator blinding) using a secure web-based portal. Participants will be called by research assistants and sent reminder emails or SMS text messages (based on their preference) to bolster the completion of follow-up questionnaires. They will receive CAD $10 (US $7.31) in compensation for each survey completed and an additional CAD $20 (US $14.62) per urine sample provided for cotinine testing.

Recruitment is expected to last a period of 9 months, with an additional 6 months required for follow-up with all recruited participants to complete data collection. The data analysis will begin with the end of recruitment and is expected to be completed in the 9 months following the final participant follow-up, for a total of a 24-month study period.

This study aims to recruit an equal number of parent and adolescent users. Parent and adolescent participants are randomized to the intervention and control groups using a 1:1 ratio. Parent and adolescent participants are stratified into 2 subgroups: those who smoke traditional combustible cigarettes (with or without e-cigarette use) and those who report exclusive use of e-cigarettes. A computer-generated randomization list created by a biostatistician external to the study team is used to randomize participants within each group.

This is a single-blinded study in which investigators will be blinded to the participant’s group allocation, and data analysis is blinded, but participants and research assistants remain unblinded. Pediatricians may decide to discuss smoking and vaping with families as part of their usual care, and participants may mention the CEASE intervention during the encounter with the provider. As such, participants and physicians will not be blinded. Participant data is anonymized using individual participant codes. No participant identifiers (eg, birth date and hospital number) are included in the database.

The capacity of CEASE to provide cessation assistance for parental and adolescent smoking and e-cigarette use is assessed using a series of outcomes detailed in Tables 1 and 2. Table 1 includes all clinic-level outcomes, while Table 2 includes all patient-level outcomes. Each table includes details and a summary of each outcome measure, their operational definition, as well as the suggested time line for data collection and feasibility threshold when applicable. Outcomes were based on Winickoff’s previous experience conducting CEASE feasibility and effectiveness trials in the United States [23].

Feasibility thresholds of 50% of potential participants screened for eligibility, 15% clinic-level smoking and vaping prevalence, 20% enrollment rate, and 3 participants (total) recruited per week (at least 6 parents and 6 adolescents recruited per month; primary outcome for this study) have been set (Table 1). Given an average of 250 patients seen per week across all 4 clinic recruitment sites, we anticipate that these thresholds will allow for 100 participants to be recruited over 36 weeks (9 months). Similarly, a feasibility threshold for baseline and follow-up questionnaire completion has been set at 90% and 80%, respectively, as shown in Table 2.

Data are obtained directly from participants through baseline and follow-up questionnaires, as well as from recruitment logs, biochemical assay results, and key informant interviews with clinic staff (eg, clinical nurse, front desk staff, and medical director) to inform about the potential impacts of the study on clinic flow. The key informant semistructured interview template is presented in Multimedia Appendix 2.

The most recent Statistics Canada data show prevalence rates for daily or occasional smoking that are higher among males (17.3%) than females (12.3%), though this gap is narrowing [33]. In Québec, where the study is conducted, smoking prevalence is slightly higher (17.0%) than the Canadian average (14.8%) [33]. Among adults, especially adults aged older than 25 years, smoking rates remain significantly higher than vaping rates, as only 3.2% of adults aged older than 25 years report past-month use of a vaping device, and a significant proportion of adult e-cigarette users report dual use of cigarettes and vaping devices [34].

The latest provincial statistics report an 18% vaping prevalence among youth aged between 15 and 17 years [35] in Quebec, which is 4.5 times higher than the smoking prevalence (4%) in this age group, though the majority of adolescents who smoke also report past use of an electronic cigarette [34].

Considering recent epidemiological trends, a conservative 15% prevalence estimate is expected for the combined use of cigarettes and vaping devices among both parents and adolescents, resulting in a potential participant pool of approximately 1 in 7 parents or adolescents presenting to the clinic. With average clinic volumes of 250 patients per week and the screening and enrollment rates mentioned above, we anticipate attaining targeted recruitment rates of 3 participants per week.

To estimate the retention rate, using a sample size of 50 participants per age group (parents and adolescents) will allow for a 95% CI within 15% of the estimate obtained. As such, if a study completion rate of 60% is observed, the 95% CI would be 44.2%-75.8%. Other research groups have reported challenges in recruiting teenagers for vaping cessation research studies [36]. As such, recruitment and retention rates are expected to differ between adult and adolescent participants; enrolling 50 parents and 50 adolescents for this pilot study will provide the 2 participation rate estimates.

Clinic-level outcomes will be evaluated using descriptive statistics (recruitment and feasibility) and qualitatively (key informant interviews). Participant-level outcomes will also be evaluated using descriptive statistics, both overall and stratified by participant type (parents vs adolescents), nicotine product used (cigarettes with or without vaping vs vaping only), and clinic where recruitment occurred. Recruitment outcomes will be compared by participant gender. Given that this is a pilot trial with insufficient power to formally test the effectiveness of CEASE, exploratory analyses comparing smoking and vaping cessation, use of cessation resources, and motivation to quit smoking and vaping between intervention and control participants will be performed to identify potential trends and signals of effectiveness in all 4 participant groups.

This study was reviewed and approved by the Institutional Review Board of the Sainte-Justine University Hospital Research Centre (2023-4237) and has been registered on ClinicalTrials.gov (NCT05366790). Any modifications or deviations from the protocol or adverse events will be recorded in the study logs on REDCap and reported immediately (within 48 hours) to the Institutional Review Board of the Sainte-Justine University Hospital Research Centre.

This is the first study to test the feasibility and preliminary effectiveness of the CEASE intervention in Canada, as well as with adolescents and individuals with exclusive e-cigarette use. If shown feasible by reaching the feasibility recruitment threshold of 6 parent and 6 adolescent participants per month, this study could allow for the planning of a full-scale randomized controlled trial testing CEASE’s effectiveness in Canada in these populations.

This study includes several strengths. First, it builds on the CEASE intervention, which has previously been demonstrated to be effective and cost-effective. Second, the electronic format of the screening and intervention will facilitate the integration of the tool in clinic workflow without any required intervention from clinical staff and will help with scale-up to additional sites. Finally, the study leverages existing cigarette and e-cigarette cessation resources, foregoing the need for additional costs for resource development. This also means that those resources can evolve and improve over time without affecting the design or feasibility of the study.

This study has certain limitations. Given the pilot nature of the study and the small sample size, this study does not have the statistical power to evaluate the effectiveness of the CEASE intervention. This study is also being conducted exclusively in an urban tertiary care hospital, which may not be reflective of pediatric clinics in community hospitals or other primary care clinics. Nonetheless, as recruitment is taking place in both general pediatric and adolescent medicine clinics as well as several specialized pediatric clinics, it allows for testing of the CEASE model in a diverse parent and adolescent patient group. Given this diversity of participants and recruitment clinics within a single center, we elected to randomize at the participant level rather than following the cluster-randomization protocol previously used to evaluate CEASE [23]. This decision does, however, pose a risk of contamination, wherein participants in the control group learn of the intervention and choose to seek out these publicly available smoking cessation resources themselves. While this may result in a decreased effect size of “The Clinical Effort Against Secondhand Smoke Exposure–Canada” (CanCEASE) in this study, all participants are offered access to these resources at the end of the study period, and the CanCEASE questionnaire itself may prompt individuals wishing to quit smoking or vaping to seek out these publicly available resources themselves during the study. Furthermore, cluster randomization would have been impractical in the context of this pilot study, as a larger sample size is required.

Logical next steps for our work will be to consider expanding CEASE recruitment to other clinic settings, including primary and secondary care clinics as well as rural settings, and conducting a full-scale cluster randomized controlled trial.

Cigarette smoking and nicotine vaping remain highly prevalent among parents and adolescents. Pediatric clinics represent an underutilized opportunity for the promotion of healthy lifestyle behaviors. This study tests the feasibility and preliminary effectiveness of a simple approach to smoking and vaping cessation. If successful, it could pave the way for a large-scale randomized controlled trial testing the effectiveness of this approach for adolescents and parents who smoke and vape in a Canadian setting. It also has the potential to inform clinicians and researchers about preferred cessation tools for parents and adolescents who use cigarettes and e-cigarettes, which remains an understudied area.

It is anticipated, based on previous implementation of CEASE in the United States, that CEASE will be feasible, as determined by a satisfactory recruitment rate as well as high proportions of participants interested in cessation, referral to cessation services, and NRT. As such, the data obtained through this study will help inform the design and implementation of a fully powered randomized controlled trial of CEASE in Canada.