NCT06470776

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 24, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

July 7, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2025

Completed
Last Updated

November 20, 2025

Status Verified

November 1, 2025

Enrollment Period

12 months

First QC Date

June 17, 2024

Last Update Submit

November 17, 2025

Conditions

Tobacco UseSmoking Cessation

Keywords

conversational agentvirtual assistantdigital healthartificial intelligencelarge language modelChatGPTadolescent

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (8)

  • Self-reported 7-day point-prevalence tobacco abstinence

    3 months after randomisation

  • Self-reported 7-day point-prevalence tobacco abstinence

    6 months after randomisation

  • Self-reported 30-day point-prevalence tobacco abstinence

    3 months after randomisation

  • Self-reported 30-day point-prevalence tobacco abstinence

    6 months after randomisation

  • Self-reported 24-hour quit attempt

    3 months after randomisation

  • +3 more secondary outcomes

Study Arms (2)

Chatbot counselling

EXPERIMENTAL

Smoking cessation counselling delivered by chatbot

Behavioral: Chatbot counselling

Peer counselling

ACTIVE COMPARATOR

Smoking cessation counselling delivered by peer counsellors

Behavioral: Peer counselling

Interventions

Chatbot counsellingBEHAVIORAL

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.

Chatbot counselling
Peer counsellingBEHAVIORAL

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

Peer counselling

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HKU Youth Quitline

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Tobacco UseSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Tzu Tsun Luk, PhD, RN

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

June 17, 2024

First Posted

June 24, 2024

Study Start

July 7, 2024

Primary Completion

June 25, 2025

Study Completion

June 25, 2025

Last Updated

November 20, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)