Designing a Smoking Intervention for Youth Smokers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: typology-based intervention, Routine Treatment.
- Who it may be relevant to
- Registry conditions: Smoking (Tobacco) Addiction, Young Adult, RCT. Basic parameters: up to 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Designing a Smoking Intervention for Youth Smokers Using Q-Methodology: A Pilot Randomized Controlled Trial
Overview
This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counsellors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counsellors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio\>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.
Detailed description
Phase 1 Q-method outcomes The outcomes of Phase 1 of this study will be Q-sorts completed by participants which will be inter-correlated producing a matrix for factor rotation and automatic flagging, and the z-score and the factor of the Q-sorts will be calculated.
The tobacco epidemic remains a pressing global health challenge, with tobacco-related illness contributing significantly to a high death rate worldwide. Smoking is the predominant mode of tobacco consumption worldwide and serves as the driving force behind this epidemic. According to the World Health Organization, there are an estimated 1.3 billion tobacco users worldwide currently. In Hong Kong, the smoking rate is estimated to be around 9.5%, with approximately 580 000 daily smokers in 2021. Despite the rate has decreased significantly from 23.3% in 1982, the Hong Kong government aims to further reduce the prevalence from 9.5% to 7.8% in 2025. The high prevalence of smoking imposes a significant public health burden worldwide, with tobacco use killing up to 50% of its users. Additionally, smoking causes cancers, stroke, cardiovascular diseases and respiratory diseases, with around 7000 deaths reported each year. One approach to reduce the smoking prevalence is to promote smoking cessation (SC) treatment among current smokers.
Young smokers constitute a large cohort of new smokers every year. It is estimated that up to 90% of daily smokers first tried smoking before 18 years old. Published studies consistently highlight the concerning prevalence of youth smoking within Hong Kong's community. Data from the recent school survey highlighted that despite only 1.2% of secondary school engages in smoking, a significant portion (7.4%, equivalent to around 24 000 students) of the youth population have previously engaged in smoking behaviour. The rate of youth ever smokers remain high at 7.4% in Hong Kong, equivalent to approximately 24 000 secondary school students, suggesting that youths are eagerly experimenting. This is also evident in the high prevalence of youths trying other tobacco products such as e-cigarettes or heated tobacco products, from 57.4% (178/310) in 2017 to 2018 to 85.9% (243/283) in 2019 to 2020. The shift from occasional smoking to dependency in youth is a crucial stage, making the adolescent years a key period for understanding and addressing smoking behaviours. It represents a key window for targeted interventions to prevent the progression towards regular smoking habits.
Smoking imposes severe health risks and long-term consequences. Effects of tobacco are well demonstrated including the effects of nicotine on brain development. The prevalence of tobacco use among youths not only jeopardizes their immediate health but negatively impacts their future well-being. Moreover, observations from Hong Kong further emphasize the pressing need for effective SC initiatives tailored to the unique needs of youths. The multifaceted challenges such as peer pressure and social influences are faced by struggling youths.
In response to these identified needs, it is imperative to develop comprehensive youth-orientated SC programs that encompass various aspects of prevention, intervention and support. Evidence-based strategies such as counselling services have shown promising outcomes in promoting smoke-free lifestyles among youths. Additionally, collaborations among healthcare institutions, government agencies and community organizations are crucial for maximizing the reach and effectiveness of cessation efforts. By addressing the health needs of local community through targeted youth SC initiatives, the investigators can significantly mitigate the adverse health effects of tobacco use among Hong Kong's young population.
Phase 3 Randomized control trial outcomes The primary outcomes of Phase 3 of this study will be smokers' (1) self-reported abstinence in the past 30 days at 2-month follow-up; (2) iScreen OFD Cotinine Saliva Test Kit (\<30ng/ml) biochemical validated tobacco abstinence; (3) the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
Interventions
- Behavioral typology-based intervention
The typology-based intervention includes: (1) a typology-based counselling, (2) instant response from a specially designed AI Chatbot for 30 days (3) Chatbot initiated AI message for 4 weeks (one message per week). All interventions and materials are delivered by smoking counselling. - Behavioral Routine Treatment
The routine smoking cessation intervention includes: (1) Routine counselling generic advice on preventing smoking relapse
Primary outcome measures
- self-reported abstinence in the past 30 days at 2-month follow-up [Time frame: 2 mouths]
- iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence [Time frame: 2 months]
- the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group. [Time frame: 2 months]
Secondary outcome measures (12)
- Time required for the counselling [Time frame: End of all follow-up (approximately 6 month)]
- Compliance rate of the SC counsellors in following the intervention protocol [Time frame: End of all follow-up (approximately 6 month)]
- Proportion of screened clients who participate in the RCT [Time frame: End of all follow-up (approximately 6 month)]
- Dropout rate of the participants who consent to the RCT [Time frame: End of all follow-up (approximately 6 month)]
- Satisfaction on the SC counsellors [Time frame: 2 months]
- Satisfaction on the AI chatbot and the chatbot initiated e-messages [Time frame: 2 months]
- Frequency of reading the chatbot initiated e-messages [Time frame: 2 months]
- Perceived effectiveness on the intervention [Time frame: 2 months]
- Satisfaction on the enrolment procedures [Time frame: 2 months]
- Intention to recommend the intervention to other smokers [Time frame: 2 months]
- Satisfaction about the intervention from SC counsellor [Time frame: End of all follow-up (approximately 6 month)]
- Perceived appropriateness of the intervention length from SC counsellor [Time frame: End of all follow-up (approximately 6 month)]
Eligibility criteria
Inclusion Criteria (Phase 1):
- Hong Kong citizens
- Have ever habitually used conventional cigarettes in the past year
- Not using cigarettes for the past 7-30 days
- Aged 25 or below (parental consent is required for participants under 18 years old)
- No barriers in communicating in Cantonese and reading and writing Chinese
- Quit smoking without using cessation services
Inclusion Criteria (Phase 3):
- Hong Kong citizens
- Have ever habitually used conventional cigarettes in the past year
- Received at least 4 weeks of smoking cessation service before enrolling into the study
- abstained from tobacco use for 7 days without concurrent use of any cessation services
- Aged 25 or below (parental consent is required for participants under 18 years old)
- No barriers in communicating in Cantonese and reading and writing Chinese
Exclusion Criteria (Phase 1 \& 3):
- Have unstable physical or psychological conditions as advised by doctors or counsellors
- Are users of illicit drugs (e.g., heroin, marijuana, ketamine, etc.)
- Have become pregnant in the past two months
- unable to communicate in Cantonese and read Chinese
Inclusion Criteria (Phase 2) (for SC counsellors) :
- SC counsellors from local SC clinics under HKU Youth Quit Line, Tung Wah Group of Hospitals Integrated Center on Smoking Cessation and United Christian Nethersole Community Health Service
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Hong Kong · 1 center
- LKS Faculty of Medicine — Hong Kong
Publications
- Zabala A, Pascual U. Bootstrapping Q Methodology to Improve the Understanding of Human Perspectives. PLoS One. 2016 Feb 4;11(2):e0148087. doi: 10.1371/journal.pone.0148087. eCollection 2016. PMID 26845694
- Watts S, Stenner P. Doing the fieldwork: participants, materials and procedure. 2012 2022/03/11. In: Doing Q Methodological Research: Theory, Method and Interpretation . London: SAGE Publications Ltd
- Karpinski JP, Timpe EM, Lubsch L. Smoking cessation treatment for adolescents. J Pediatr Pharmacol Ther. 2010 Oct;15(4):249-63. PMID 22477813
- Bailey SR, Crew EE, Riske EC, Ammerman S, Robinson TN, Killen JD. Efficacy and tolerability of pharmacotherapies to aid smoking cessation in adolescents. Paediatr Drugs. 2012 Apr 1;14(2):91-108. doi: 10.2165/11594370-000000000-00000. PMID 22248234
- Duncan Millar J, Mason H, Kidd L. What is Q methodology? Evid Based Nurs. 2022 Jul;25(3):77-78. doi: 10.1136/ebnurs-2022-103568. Epub 2022 May 24. No abstract available. PMID 35609957
- Bowen NK, Lee JS, Weller BE. SOCIAL ENVIRONMENTAL RISK AND PROTECTION: A TYPOLOGY WITH IMPLICATIONS FOR PRACTICE IN ELEMENTARY SCHOOLS. Child Sch. 2007;29(4):229-242. doi: 10.1093/cs/29.4.229. PMID 21709821
- Tombor I, Shahab L, Herbec A, Neale J, Michie S, West R. Smoker identity and its potential role in young adults' smoking behavior: A meta-ethnography. Health Psychol. 2015 Oct;34(10):992-1003. doi: 10.1037/hea0000191. Epub 2015 Jan 26. PMID 25622078
- Jarvelaid M. Adolescent tobacco smoking and associated psychosocial health risk factors. Scand J Prim Health Care. 2004 Mar;22(1):50-3. doi: 10.1080/02813430310000988. PMID 15119521
Identifiers
NCT: NCT07178899 · 08230208