Designing a Smoking Intervention for Youth Smokers Using Q-Methodology: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- self-reported abstinence in the past 30 days at 2-month follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •(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
结局指标
主要结局
self-reported abstinence in the past 30 days at 2-month follow-up
时间窗: 2 mouths
iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence
时间窗: 2 months
Participants who report tobacco abstinence will be invited for a biochemical validation to test if his/her saliva cotinine is less than 30ng/ml measured by the iScreen OFD Cotinine Saliva Test Kit.
the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
时间窗: 2 months
The investigators will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree). Also, the investigators will have 4 acceptability questions for ex-smokers to answer. The investigators would like to observe if there is a difference between the intervention group and the control group
次要结局
- Proportion of screened clients who participate in the RCT(End of all follow-up (approximately 6 month))
- Dropout rate of the participants who consent to the RCT(End of all follow-up (approximately 6 month))
- Satisfaction on the e-messages(2 months)
- Frequency of reading the e-messages(2 months)
- Satisfaction on the enrolment procedures(2 months)
- Intention to recommend the intervention to other smokers(2 months)
- Satisfaction about the intervention from SC counsellor(End of all follow-up (approximately 6 month))
- Perceived appropriateness of the intervention length from SC counsellor(End of all follow-up (approximately 6 month))
- Satisfaction on the enrolment and counselling procedures from SC counsellors(End of all follow-up (approximately 6 month))
- Perceived effectiveness of the screening tool from SC counsellor(End of all follow-up (approximately 6 month))
- Perceived clients' acceptance of the intervention from SC counsellor(2 months)
- Satisfaction on the SC counsellors(2 months)
- Perceived effectiveness on the intervention(2 months)
- Intention to apply this intervention in other clients from SC counsellors(End of all follow-up (approximately 6 month))
- Satisfaction about the intervention from SC counsellor(End of all follow-up (approximately 6 month))
- Time required for the counselling(End of all follow-up (approximately 6 month))
- Compliance rate of the SC counsellors in following the intervention protocol(End of all follow-up (approximately 6 month))
- Proportion of screened clients who participate in the RCT(End of all follow-up (approximately 6 month))
- Dropout rate of the participants who consent to the RCT(End of all follow-up (approximately 6 month))
- Satisfaction on the SC counsellors(2 months)
- Satisfaction on the e-messages(2 months)
- Frequency of reading the e-messages(2 months)
- Perceived effectiveness on the intervention(2 months)
- Satisfaction on the enrolment procedures(2 months)
- Intention to recommend the intervention to other smokers(2 months)
- Perceived appropriateness of the intervention length from SC counsellor(End of all follow-up (approximately 6 month))
- Satisfaction on the enrolment and counselling procedures from SC counsellors(End of all follow-up (approximately 6 month))
- Perceived effectiveness of the screening tool from SC counsellor(End of all follow-up (approximately 6 month))
- Perceived clients' acceptance of the intervention from SC counsellor(2 months)
- Intention to apply this intervention in other clients from SC counsellors(End of all follow-up (approximately 6 month))
研究者
CHEUNG, Cara Hor Yine
Post Doctoral Fellow
The University of Hong Kong
