An Integrated Smoking Cessation and Alcohol Intervention for Young People

Study Overview
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Brief Summary
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The study will be a three-arm randomized controlled trial in a convenience sample of 150 smokers aged 18-25 years with a drinking habit who will be recruited from smoking hotspots in Mong Kok. Participants will be randomized into a standard treatment (ST), II, or control arm. Participants in the ST arm will receive a brief smoking cessation intervention based on the Asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit, Assisting in quitting, and Arranging for follow-up and Relevance, Risks, Rewards, Roadblocks and Repetition models. Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention. Booster interventions will be provided to both ST and II arms at 1-week, 1-month, 3-month, and 6-month follow-up. Participants in the control arm will receive leaflets on smoking cessation and alcohol abstinence. Data collection will be done at baseline and at 1-week, 1-month, 3-month, and 6-month follow-ups. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.

Official Title
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An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People: A Feasibility Randomized Controlled Trial

Conditions
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Smoking Cessation, Alcohol Drinking

Intervention / Treatment
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* Behavioral: Standard treatment (ST) arm
* Other: Integrated Intervention (II) arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoked at least one cigarette in the past 30 days have consumed at least one cup of alcohol (10 ounces of beer, 4 ounces of wine, or 1 ounce of liquor) in the past 30 days speak Cantonese. Exclusion Criteria: have a compromised mental status and/or communication problems participating in other smoking cessation interventions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard treatment (ST) arm<br>Participants will receive a brief smoking cessation intervention based on the asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit,Assisting in quitting, and Arranging for follow-up and relevance, risks, rewards, roadblocks and repetition models at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up. | Behavioral: Standard treatment (ST) arm<br>* Participants will receive a brief smoking cessation intervention based on the asking about tobacco use, Advising smokers to quit, Assessing their willingness to quit,Assisting in quitting, and Arranging for follow-up and relevance, risks, rewards, roadblocks and repetition models at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up.<br>|
| Experimental: Integrated Intervention (II) arm<br>Participants in the II arm will receive brief advice on alcohol use based on the FRAMES model in addition to the brief smoking cessation intervention at baseline. Booster interventions will be provided to ST arm at 1-week, 1-month, 3-month, and 6-month follow-up. | Other: Integrated Intervention (II) arm<br>* Participants will receive brief advice on alcohol use based on the FRAMES model, which is a well-established and effective brief intervention for drinking.<br>|
| No Intervention: Control arm<br>Participants will be provided with two leaflets designed by Department of health: one for smoking cessation and another for alcohol abstinence. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screening rate | the number of people screened divided by the number of people available for screening | 24 months | 
| eligibility rate | the number of eligible smokers divided by the number of screened people. | 24 months | 
| consent rate | the number of eligible smokers who agree to participate divided by the number of eligible smokers | 24 months | 
| randomization rate | the number of participants who are randomized divided by the number of eligible smokers who consent to participate | 24 months | 
| attendance rate | the number of participants who complete the intervention divided by the number of participants who are randomized into the treatment arms | 24 months | 
| adherence to intervention | the number of participants in the two treatment arms who practice the skills learned during the intervention divided by the number of participants in the two treatment arms | 24 months | 
| retention rate | the number of participants who remain in the study | 24 months | 
| completion rate | the number of participants who complete the questionnaire | 24 months | 
| missing data | the percentage of missing data | 24 months | 
| adverse events | unfavorable or unintended events | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| self-reported quit rate | self-report no use of any tobacco products | 6 month | 
| biochemically validated quit rate | biochemically verified | 6 month |