Chatbot Counselling for Smoking Cessation in Youths

Development of a Chatbot for Smoking Cessation Counselling for Youth Smokers Enrolled in the Youth Quitline: a Pilot Randomised Trial

The goal of this pilot trial is to develop and examine the trial feasibility and acceptability of a chatbot for smoking cessation in youth smokers. Specific aims include:

1. To assess how many youth smokers accept the invitation to participate in the trial
2. To assess the retention of the participants through 6 months after treatment initiation
3. To assess the acceptability of the chatbot in terms of participants' compliance and usability rating of the chatbot.
4. To estimate the intervention effect on abstinence outcomes
5. To explore the participants' perception and experiences in the chatbot

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Tobacco Use
• Intervention / Treatment: Behavioral: Chatbot counselling; Behavioral: Peer counselling

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • HKU Youth Quitline

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Hong Kong residents aged 25 years or younger
2. Used a tobacco product in the past 30 days, including cigarettes, electronic cigarettes, heated tobacco products, etc.
3. Able to communicate in Chinese
4. Own a smartphone with internet access

Exclusion Criteria:

1. Diagnosed with a mental disease or on regular psychotropic drugs, or
2. Participating in other ongoing smoking cessation studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chatbot counselling; Smoking cessation counselling delivered by chatbot	Behavioral: Chatbot counselling; Access to a chatbot that provides smoking cessation counselling based on the 5A's (Ask, Advice, Assess, Assist, Arrange follow-up) and 5R's (Risk, Relevance, Rewards, Relevance, Roadblocks, Repetition) tobacco intervention models from baseline to 3-month post-baseline.
Active Comparator: Peer counselling; Smoking cessation counselling delivered by peer counsellors	Behavioral: Peer counselling; Usual treatment provided by the Youth Quitline, i.e., telephone counselling for smoking cessation based on the 5As and 5Rs models delivered by trained peer counsellors at baseline and 1 week, 1 month and 3 months post-baseline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-validated tobacco abstinence	Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)	6 months after randomisation
Recruitment rate	Number of participants divided by the number of eligible subjects	Through recruitment completion, about 9 months
Retention rate	Number of participants completed the follow-up divided by the number of participants	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	3 months after randomisation
Self-reported 7-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 7 days	6 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 30 days	3 months after randomisation
Self-reported 30-day point-prevalence tobacco abstinence	Being completely smoke-free in the past 30 days	6 months after randomisation
Self-reported 24-hour quit attempt	Serious attempt to quit smoking for 24 hours or longer in daily smokers	3 months after randomisation
Self-reported 24-hour quit attempt	Serious attempt to quit smoking for 24 hours or longer in daily smokers	6 months after randomisation
Self-reported 50% smoking reduction	Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers	3 months after randomisation
Self-reported 50% smoking reduction	Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers	6 months after randomisation

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Health and Medical Research Fund
• Investigators: Principal Investigator: Tzu Tsun Luk, PhD, RN, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2024
• Primary Completion (Actual): June 25, 2025
• Study Completion (Actual): June 25, 2025

Study Registration Dates

• First Submitted: June 17, 2024
• First Submitted That Met QC Criteria: June 17, 2024
• First Posted (Actual): June 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: adolescent; artificial intelligence; digital health; conversational agent; ChatGPT; large language model; virtual assistant
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Tobacco Use
• Other Study ID Numbers: 20212551

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No