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

Adolescent Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875546
• Other study ID #: Smk_AI-RCT
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2021
• Source: The Hong Kong Polytechnic University
• Contact: Ka Yan Ho, Phd
• Phone: 27666417
• Email: kyeva.ho[@]polyu.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior

Intervention

Behavioral:
• Standard treatment
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.
• Integrated Intervention
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.

Other:
• Control
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.

Locations

Country	Name	City	State
Hong Kong	Ka Yan Ho	Hong Kong	Hong Kong,China

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The biochemical validation	Measuring the level of carbon monoxide in expired air and level of cotinine in saliva	At the 6-month follow-up
Primary	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	Randomization rate	The number of participants who randomized divided by the number of eligible smokers who consent to participate	Immediately after the training workshop
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Completion rate at baseline	The number of participants who complete the questionnaire divided by the number of questionnaires distributed.	At baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Missing data at baseline	The percentage of missing data.	At baseline
Secondary	Missing data at 1-week follow-up	The percentage of missing data.	At 1-week follow-up
Secondary	Missing data at 1-month follow-up	The percentage of missing data.	At 1-month follow-up
Secondary	Missing data at 3-month follow-up	The percentage of missing data.	At 3-month follow-up
Secondary	Missing data at 6-month follow-up	The percentage of missing data.	At 6-month follow-up
Secondary	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
Secondary	Screen rate	The number of people screened divided by the number of people available for screening.	Immediately after the training workshop
Secondary	Consent rate	The number of eligible smokers who agree to participate divided by the number of eligible smokers	Immediately after the training workshop
Secondary	Eligibility rate	The number of eligible smokers divided by the number of screened people.	Immediately after the training workshop