Designing a Smoking Intervention for Youth Smokers
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 25
SponsorThe University of Hong Kong
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
typology-based intervention
BehavioralThe 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 Treatment
BehavioralThe routine smoking cessation intervention includes: (1) Routine counselling generic advice on preventing smoking relapse
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Typology-based Intervention (Intervention group)Experimental treatment 1 intervention
Group B: Routine Treatment (Control Group)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
self-reported abstinence in the past 30 days at 2-month follow-up
Time frame
2 mouths2
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.
Time frame
2 months3
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
Time frame
2 monthsSecondary outcomes
1
Time required for the counselling
The average time required for the typological counselling in minutes
Time frame
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
Time frame
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"
Time frame
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"
Time frame
End of all follow-up (approximately 6 month)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: