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Completed

NCT Number: NCT06470776

Chatbot Counselling for Smoking Cessation in Youths

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

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Key information

Conditions

Tobacco Use Behavior Health Behavior Smoking Cessation

Age range

Up to 25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HKU Youth Quitline

Hong Kong

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Chatbot counselling

Behavioral

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.

Peer counselling

Behavioral

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

Primary outcomes

  1. Biochemically-validated tobacco abstinence

    Time frame: 6 months after randomisation

    Defined as a negative result of the iScreen OFD test for measuring salivary cotinine (with a cut-off of lower than 30ng/mL)

  2. Recruitment rate

    Time frame: Through recruitment completion, about 9 months

    Number of participants divided by the number of eligible subjects

  3. Retention rate

    Time frame: 6 months

    Number of participants completed the follow-up divided by the number of participants

Secondary outcomes

  1. Self-reported 7-day point-prevalence tobacco abstinence

    Time frame: 3 months after randomisation

    Being completely smoke-free in the past 7 days

  2. Self-reported 7-day point-prevalence tobacco abstinence

    Time frame: 6 months after randomisation

    Being completely smoke-free in the past 7 days

  3. Self-reported 30-day point-prevalence tobacco abstinence

    Time frame: 3 months after randomisation

    Being completely smoke-free in the past 30 days

  4. Self-reported 30-day point-prevalence tobacco abstinence

    Time frame: 6 months after randomisation

    Being completely smoke-free in the past 30 days

  5. Self-reported 24-hour quit attempt

    Time frame: 3 months after randomisation

    Serious attempt to quit smoking for 24 hours or longer in daily smokers

  6. Self-reported 24-hour quit attempt

    Time frame: 6 months after randomisation

    Serious attempt to quit smoking for 24 hours or longer in daily smokers

  7. Self-reported 50% smoking reduction

    Time frame: 3 months after randomisation

    Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers

  8. Self-reported 50% smoking reduction

    Time frame: 6 months after randomisation

    Smoking reduction by at least half of the baseline daily number of cigarettes in continued smokers

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Health and Medical Research Fund

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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