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Smoking (Tobacco) AddictionNCT07178899

Designing a Smoking Intervention for Youth Smokers

A study testing typology-based intervention and Routine Treatment in people with Smoking (Tobacco) Addiction and Young Adult, run by The University of Hong Kong at 1 site in Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages Up to 25 yearsHealthy volunteers can take part
Conditions the study is for
Smoking (Tobacco) Addiction, Young Adult, RCT
What is being tested?
typology-based intervention and Routine Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteHong Kong
Study dates
5 Jun 2026to 30 Jun 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Cara Hor Yine Cheung, Dr. contact

+852 39103198

chycheun@hku.hk

Hong Kong1 site

  • LKS Faculty of Medicine

    Hong Kong

    Cara Hor Yine Cheung, Dr., +852 39103198, chycheun@hku.hk

Other trials in Hong Kong

About this study

Official title: Designing a Smoking Intervention for Youth Smokers Using Q-Methodology: A Pilot Randomized Controlled Trial

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.

Read the 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.

Being tested
typology-based intervention, Routine Treatment
Keywords
Smoking Cessation, Young Adult, RCT
Medical subject headings
Smoking, Behavior, Addictive, Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • typology-based interventionBehavioural

    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.

  • Routine TreatmentBehavioural

    The routine smoking cessation intervention includes: (1) Routine counselling generic advice on preventing smoking relapse

Study groups in NCT07178899
Study groupRoleWhat they receive
Typology-based Intervention (Intervention group)ExperimentalIn the Typology-based intervention group, in addition to routine counselling, counsellors will apply typological counselling protocol for the participants. The counselling protocol includes 12 distinguishing statement in Q-methodology. Counsellor will discuss these statements with participants and collect their viewpoints on these statements. After the counselling session, participant can chat with the AI chatbot in WhatsApp for 30 days. The chatbot is specially designed and able to read the content of typological counselling of each participant and provide instant response. In addition to incoming message, the AI chatbot will sent personalized e-messages automatically to encourage participants to engage in discussion with chatbot. The frequency of messages will be one message per week, total 4 for 4 weeks.
Receives: Behavioral: typology-based intervention
Routine Treatment (Control Group)Active comparatorIn the Routine Treatment group, the routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained.
Receives: Behavioral: Routine Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. self-reported abstinence in the past 30 days at 2-month follow-up

    Measured: 2 mouths

  2. iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence

    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.

    Measured: 2 months

  3. the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.

    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

    Measured: 2 months

Secondary outcomes (16)

  1. Time required for the counselling

    The average time required for the typological counselling in minutes

    Measured: End of all follow-up (approximately 6 month)

  2. Compliance rate of the SC counsellors in following the intervention protocol

    There were 26 questions in the counselling protocol. SC counsellors have to record the number of questions asked during the typological counselling. The rate is calculated by "number of questions asked"/26

    Measured: End of all follow-up (approximately 6 month)

  3. Proportion of screened clients who participate in the RCT

    The proportion is calculated by "Number of enrolled participants" / "Total number of participant screened"

    Measured: End of all follow-up (approximately 6 month)

  4. Dropout rate of the participants who consent to the RCT

    The dropout rate is calculated by "Number of participants dropout from study" / "Total number of enrolled participant"

    Measured: End of all follow-up (approximately 6 month)

  5. Satisfaction on the SC counsellors

    Satisfaction on the SC counsellors is measured by a 5 point Likert scale reported by the enrolled participants, from 1: Very Dissatisfied to 5: Very Satisfied.

    Measured: 2 months

  6. Satisfaction on the AI chatbot and the chatbot initiated e-messages

    Satisfaction on AI chatbot and the chatbot initiated is measured by a 10 point Likert scale reported by the enrolled participants, from 1: Very Dissatisfied to 10: Very Satisfied.

    Measured: 2 months

  7. Frequency of reading the chatbot initiated e-messages

    The Frequency of reading the e-messages is measured by 5 point Likert scale, that indicate the number of e-messages that the participant had read, from 1 (indicate the participant had read none of the e-messages), to 5 (indicate the participant had read all of the e-messages).

    Measured: 2 months

  8. Perceived effectiveness on the intervention

    The perceived effectiveness on the intervention is measured by a 10 point likert scale. Participant will rate the usefulness of the intervention received in helping them to maintain smoking abstinence (10: Very useful | 0: Useless).

    Measured: 2 months

  9. Satisfaction on the enrolment procedures

    Satisfaction on the enrolment procedures is measured by a 10 point Likert scale reported by the participants (0: The enrollment procedure is slow and complicated | 10: the enrollment procedure is fast and simple).

    Measured: 2 months

  10. Intention to recommend the intervention to other smokers

    Intention to recommend the intervention to other smokers is measured by a 10 point Likert scale, 10: strongly recommended to other smokers | 0: not recommended to other smoker

    Measured: 2 months

  11. Satisfaction about the intervention from SC counsellor

    Satisfaction about the intervention from SC counsellor is measured by a 5 point Likert scale. SC counsellor will rate the effectiveness of the typological counselling in helping their client to quit smoking, from 1: very ineffective to 5: very effective.

    Measured: End of all follow-up (approximately 6 month)

  12. Perceived appropriateness of the intervention length from SC counsellor

    The perceived appropriateness of the intervention length from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the length of the typological counselling is suitable for their client, from 1 strongly disagree to 5 strongly agree.

    Measured: End of all follow-up (approximately 6 month)

  13. Satisfaction on the enrolment and counselling procedures from SC counsellors

    The satisfaction on the enrolment procedures from SC counsellors is measured by a 5 point Likert scale. Counsellors will be asked if they agreed that enrolment and counselling procedures is simple and could be easily done in the SC clinics, from 1: strongly disagree to 5: strongly agree.

    Measured: End of all follow-up (approximately 6 month)

  14. Perceived effectiveness of the counselling protocol from SC counsellor

    The perceived effectiveness of the counselling protocol from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the typological intervention can help them screen out smokers who are prone to relapse, from 1: strongly disagree to 5: strongly agree.

    Measured: End of all follow-up (approximately 6 month)

  15. Perceived clients' acceptance of the intervention from SC counsellor

    The Perceived clients' acceptance of the intervention from SC counsellor is measured by a 5 point Likert scale. Participants are asked if they agreed that counselling content provided the SC counselling gain their trust and acceptance, from 1: strongly disagree to 5: strongly agree.

    Measured: 2 months

  16. Intention to apply this intervention in other clients from SC counsellors

    Intention to apply this intervention in other clients from SC counsellors is measured by a 5 point Likert scale. SC counsellors are asked if they want to apply the typological intervention to other clients in future, from 1: SC counsellors will not apply it to their client in the future, to 5: SC counsellors want to apply it their client in the future.

    Measured: End of all follow-up (approximately 6 month)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2025
  2. Study start5 Jun 2026 (estimated)
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
two arms: typology-based intervention (intervention group) \& routine treatment (control group)
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07178899
Sponsor's protocol ID
08230208
Status last verified
May 2026
First submitted
10 Sep 2025
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Research data and documentation will be available upon request

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 15119521

  • Tombor I, Vangeli E, West R, Shahab L. Progression towards smoking cessation: Qualitative analysis of successful, unsuccessful, and never quitters. J Subst Use. 2017 Oct 5;23(2):214-222. doi: 10.1080/14659891.2017.1378746. eCollection 2018.

    PubMed 29527597

  • Rose JS, Chassin L, Presson C, Sherman SJ, Stein MD, Col N. A latent class typology of young women smokers. Addiction. 2007 Aug;102(8):1310-9. doi: 10.1111/j.1360-0443.2007.01889.x.

    PubMed 17624981

  • Thomas JL, Luo X, Bengtson J, Wang Q, Ghidei W, Nyman J, Lust K, An L, Wetter DW, Epstein L, Ahluwalia JS. Enhancing Quit & Win contests to improve cessation among college smokers: a randomized clinical trial. Addiction. 2016 Feb;111(2):331-9. doi: 10.1111/add.13144. Epub 2015 Nov 11.

    PubMed 26767340

  • Villanti AC, West JC, Klemperer EM, Graham AL, Mays D, Mermelstein RJ, Higgins ST. Smoking-Cessation Interventions for U.S. Young Adults: Updated Systematic Review. Am J Prev Med. 2020 Jul;59(1):123-136. doi: 10.1016/j.amepre.2020.01.021. Epub 2020 May 14.

    PubMed 32418800

  • Chaiton M, Diemert L, Cohen JE, Bondy SJ, Selby P, Philipneri A, Schwartz R. Estimating the number of quit attempts it takes to quit smoking successfully in a longitudinal cohort of smokers. BMJ Open. 2016 Jun 9;6(6):e011045. doi: 10.1136/bmjopen-2016-011045.

    PubMed 27288378

  • Rosa JD, Aloise-Young P. A Qualitative Study of Smoker Identity Among College Student Smokers. Subst Use Misuse. 2015;50(12):1510-7. doi: 10.3109/10826084.2015.1018549. Epub 2015 Nov 19.

    PubMed 26584272

  • Davey, G. and Zhao, X. (2020), Turning Points to Becoming a Tobacco Smoker: Smoking Initiation and Identity Change among Chinese Youth. Symbolic Interaction, 43: 308-331

Questions about this trial

What is this clinical trial studying?

A study testing typology-based intervention and Routine Treatment in people with Smoking (Tobacco) Addiction and Young Adult, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cara Hor Yine Cheung, Dr. (+852 39103198, chycheun@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

self-reported abstinence in the past 30 days at 2-month follow-up (time frame: 2 mouths). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07178899, which also lists 28 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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