An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People

Study Overview
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Brief Summary
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Current smoking cessation interventions are focused only on smoking behaviors, and drinking habits are generally overlooked. The aims of the project is to examine the feasibility of implementing an integrated smoking cessation and alcohol abstinence intervention in young Hong Kong Chinese smokers.

Detailed Description
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The study is a three-arm randomized controlled trial. (1)The standard treatment group , participants will receive a brief smoking cessation intervention based on the '5A' and '5R' model, then the RA will assist the participants to quit smoking using the STAR method. (2) For the alcohol intervention group, participants will also receive a brief smoking cessation intervention with the models as the ST group. After that they will receive a brief advice on alcohol use based on the FRAMES model. Then the RA will invite participants to complete the Alcohol Use Disorders Identification Test(AUDIT). (3) For the Control group, participants will be provide with two leaflets, one for smoking cessation and another for alcohol abstinence. All the data collection will be conducted at baseline, 1 week, 1 month , 3 months and 6 months for follow up.

Official Title
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An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People

Conditions
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Adolescent Behavior

Intervention / Treatment
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* Behavioral: Standard treatment
* Behavioral: Integrated Intervention
* Other: Control


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 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: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>A 5'A' and '5'R' models STAR method for quitting | Behavioral: Standard treatment<br>* Adolescent will receive a brief smoking cessation intervention based on the '5A' and '5R' models. Then the research assistant will ask about their tobacco use and assist them to quit using the STAR method. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.<br>|
| Active Comparator: Integrated Intervention<br>A 5'A' and '5'R' models Receive brief advice on alcohol use based on the FRAMES model Complete the Alcohol Use Disorders Identification Test | Behavioral: Integrated Intervention<br>* In addition to the brief smoking cessation intervention based on the '5A' and '5R' models, the participants will receive brief advice on alcohol use based on the FRAMES model. Then the RA will invite participants to complete the Alcohol Use Disorders Identification Test and provide personalized feedback. There will be a one to one, 20-30 minutes semi-structured interviews with 30 participants. Participants with high(N=15) and low (N=15) adherence will be purposively selected. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.<br>|
| Sham Comparator: Control<br>Participants will receive two leaflets. | Other: Control<br>* The adolescents will receive the leaflets for smoking cessation and alcohol abstinence. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The biochemical validation | Measuring the level of carbon monoxide in expired air and level of cotinine in saliva | At the 6-month follow-up | 
| Structured questionnaire | The questionnaire will include six areas: smoking profile, cessation history, readiness to quit, self-efficacy to quit, alcohol use and demographics. | At baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Randomization rate | The number of participants who randomized divided by the number of eligible smokers who consent to participate | Immediately after the training workshop | 
| Attendance rate | The number of participants who complete intervention divided by the number of participants who are randomized into the treatment arms participants who are randomized into the treatment arms | Immediately after the training workshop | 
| Adherence to intervention at baseline | 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 during the intervention divided by the number of participants in the two treatment arm. | At baseline | 
| Adherence to intervention at 1-week follow-up | 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 during the intervention divided by the number of participants in the two treatment arm. | At 1-week follow-up | 
| Adherence to intervention at 1-month follow-up | 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 during the intervention divided by the number of participants in the two treatment arm. | At 1-month follow-up | 
| Adherence to intervention at 3-month follow-up | 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 during the intervention divided by the number of participants in the two treatment arm. | At 3-month follow-up | 
| Adherence to intervention at 6-month follow-up | 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 during the intervention divided by the number of participants in the two treatment arm. | At 6-month follow-up | 
| Retention rate at baseline | The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups. | At baseline | 
| Retention rate at 1-week follow-up | The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups. | At 1-week follow-up | 
| Retention rate at 1-month follow-up | The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups. | At 1-month follow-up | 
| Retention rate at 3-month follow-up | The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups. | At 3-month follow-up | 
| Retention rate at 6 month follow-up | The number of participants who remain in the study divided by the number of participants randomized. Retention rate will be calculated for each arm at baseline and follow-ups. | At 6-month follow-up | 
| Completion rate at baseline | The number of participants who complete the questionnaire divided by the number of questionnaires distributed. | At baseline | 
| Completion rate at 1-week follow-up | The number of participants who complete the questionnaire divided by the number of questionnaires distributed. | At 1-week follow-up | 
| Completion rate at 1-month follow-up | The number of participants who complete the questionnaire divided by the number of questionnaires distributed. | At 1-month follow-up | 
| Completion rate at 3-month follow-up | The number of participants who complete the questionnaire divided by the number of questionnaires distributed. | At 3-month follow-up | 
| Completion rate at 6-month follow-up | The number of participants who complete the questionnaire divided by the number of questionnaires distributed. | At 6-month follow-up | 
| Missing data at baseline | The percentage of missing data. | At baseline | 
| Missing data at 1-week follow-up | The percentage of missing data. | At 1-week follow-up | 
| Missing data at 1-month follow-up | The percentage of missing data. | At 1-month follow-up | 
| Missing data at 3-month follow-up | The percentage of missing data. | At 3-month follow-up | 
| Missing data at 6-month follow-up | The percentage of missing data. | At 6-month follow-up | 
| Adverse events | Unfavorable or unintended events during the study period that were not present at baseline or appear to have worsened since baseline | At the 6 months follow up | 
| Screen rate | The number of people screened divided by the number of people available for screening. | Immediately after the training workshop | 
| Consent rate | The number of eligible smokers who agree to participate divided by the number of eligible smokers | Immediately after the training workshop | 
| Eligibility rate | The number of eligible smokers divided by the number of screened people. | Immediately after the training workshop | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, alcohol, adolescents