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

NCT07178899 | Not Yet Recruiting

• 1 other identifier: 08230208
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Smoking (Tobacco) Addiction; Young Adult; RCT

Keywords

Smoking Cessation; Young Adult; RCT

Outcome Measures

Primary Outcomes (3)

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

  2 mouths

• 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.

  2 months

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

  We will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree). Also, we will have 4 acceptability questions for ex-smokers to answer. We would like to observe if there is a difference between the intervention group and the control group

  2 months

Secondary Outcomes (16)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

In the intervention group, in addition to routine counselling (15-30 minutes), they will classify their identity with our screening tool (developed in Phase 2) and then apply the counselling protocol for the participants (5-10 minutes). After the counselling session, the personalized e-messages will be sent to the participants by the counsellor for 4 weeks.

Behavioral: typology-based intervention

Control Group

ACTIVE COMPARATOR

In the control group, the routine smoking cessation counselling, including generic advice on preventing smoking relapse, will be retained, and they will receive brief e-messages that only consist of general quit advice for 4 weeks.

Behavioral: Routine Treatment

Interventions

typology-based intervention BEHAVIORAL

The typology-based intervention includes: (1) typology-based counselling, (2) personalized E-message based on the counselling content discussed (3) a booklet introducing the typology of quit identity. All interventions and materials are delivered by smoking counselling.

Intervention group

Routine Treatment BEHAVIORAL

The routine smoking cessation intervention includes: (1) Routine counselling generic advice on preventing smoking relapse (2) Brief e-messages that consist of general quit advice for 4 weeks. Counsellors implement both routine practices.

Control Group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Hong Kong citizens
• Have ever habitually used conventional cigarettes in the past year
• Not using cigarettes for the past 7 days
• Aged 18-25
• No barriers in communicating in Cantonese and reading and writing Chinese
• Quit smoking without using cessation services
• 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 to 30 days without using any cessation services
• Aged 18-25
• No barriers in communicating in Cantonese and reading and writing Chinese

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

LKS Faculty of Medicine

Hong Kong, Hong Kong

Location

Related Publications (28)

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MeSH Terms

Conditions

Smoking; Behavior, Addictive; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Compulsive Behavior; Impulsive Behavior; Health Behavior

Central Study Contacts

Cara Hor Yine Cheung, Dr.

CONTACT

+852 39103198; chycheun@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post Doctoral Fellow

Model Details: two arms: intervention group \& control group

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 3 years after the completion of the relevant publications

Locations

HK (1)