Adolescent BehaviorNCT04875546
An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People
A study testing Standard treatment and Integrated Intervention in people with Adolescent Behavior, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Behavior
- What is being tested?
- Standard treatment and Integrated Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- have a compromised mental status and/or communication problems.
- participating in other smoking cessation interventions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Adolescent Behavior
- Being tested
- Standard treatment, Integrated Intervention, Control
- Keywords
- smoking, alcohol, adolescents
- Medical subject headings
- Adolescent Behavior, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatmentBehavioural
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 InterventionBehavioural
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.
ControlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment | Active comparator | * A 5'A' and '5'R' models
* STAR method for quitting Receives: Behavioral: Standard treatment |
| Integrated Intervention | Active comparator | * 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 Receives: Behavioral: Integrated Intervention |
| Control | Sham comparator | Participants will receive two leaflets. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The biochemical validation
Measuring the level of carbon monoxide in expired air and level of cotinine in saliva
Measured: 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.
Measured: At baseline
Secondary outcomes (26)
Randomization rate
The number of participants who randomized divided by the number of eligible smokers who consent to participate
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6-month follow-up
Completion rate at baseline
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Measured: At baseline
Completion rate at 1-week follow-up
The number of participants who complete the questionnaire divided by the number of questionnaires distributed.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 6-month follow-up
Missing data at baseline
The percentage of missing data.
Measured: At baseline
Missing data at 1-week follow-up
The percentage of missing data.
Measured: At 1-week follow-up
Missing data at 1-month follow-up
The percentage of missing data.
Measured: At 1-month follow-up
Missing data at 3-month follow-up
The percentage of missing data.
Measured: At 3-month follow-up
Missing data at 6-month follow-up
The percentage of missing data.
Measured: 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
Measured: At the 6 months follow up
Screen rate
The number of people screened divided by the number of people available for screening.
Measured: Immediately after the training workshop
Consent rate
The number of eligible smokers who agree to participate divided by the number of eligible smokers
Measured: Immediately after the training workshop
Eligibility rate
The number of eligible smokers divided by the number of screened people.
Measured: Immediately after the training workshop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent BehaviorStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
- Investigators
- Ka Yan Ho, Phd, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875546
- Sponsor's protocol ID
- Smk_AI-RCT
- Status last verified
- May 2021
- First submitted
- 20 Apr 2021
- Last updated
- 6 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Smoking Cessation and Alcohol Intervention Among Hong Kong Chinese Young People
- ClinicalTrials.gov ID
- NCT04875546
- Acronym / sponsor ID
- Smk_AI-RCT
- Conditions
- Adolescent Behavior
- Keywords
- smoking, alcohol, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 6 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard treatment | Active comparator | Behavioral: Standard treatment* A 5'A' and '5'R' models * STAR method for quitting |
| Integrated Intervention | Active comparator | Behavioral: Integrated Intervention* 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 |
| Control | Sham comparator | Other: ControlParticipants will receive two leaflets. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- have a compromised mental status and/or communication problems.
- participating in other smoking cessation interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatmentAdolescent 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. | Behavioural | Standard treatment |
| Integrated InterventionIn 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. | Behavioural | Integrated Intervention |
| ControlThe 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. | Other | Control |
Primary outcome
The biochemical validation
Time frame: At the 6-month follow-up
Measuring the level of carbon monoxide in expired air and level of cotinine in saliva
Structured questionnaire
Time frame: At baseline
The questionnaire will include six areas: smoking profile, cessation history, readiness to quit, self-efficacy to quit, alcohol use and demographics.
26 secondary outcomes
Randomization rate
Time frame: Immediately after the training workshop
Attendance rate
Time frame: Immediately after the training workshop
Adherence to intervention at baseline
Time frame: At baseline
Adherence to intervention at 1-week follow-up
Time frame: At 1-week follow-up
Adherence to intervention at 1-month follow-up
Time frame: At 1-month follow-up
Adherence to intervention at 3-month follow-up
Time frame: At 3-month follow-up
Adherence to intervention at 6-month follow-up
Time frame: At 6-month follow-up
Retention rate at baseline
Time frame: At baseline
Retention rate at 1-week follow-up
Time frame: At 1-week follow-up
Retention rate at 1-month follow-up
Time frame: At 1-month follow-up
Retention rate at 3-month follow-up
Time frame: At 3-month follow-up
Retention rate at 6 month follow-up
Time frame: At 6-month follow-up
Completion rate at baseline
Time frame: At baseline
Completion rate at 1-week follow-up
Time frame: At 1-week follow-up
Completion rate at 1-month follow-up
Time frame: At 1-month follow-up
Completion rate at 3-month follow-up
Time frame: At 3-month follow-up
Completion rate at 6-month follow-up
Time frame: At 6-month follow-up
Missing data at baseline
Time frame: At baseline
Missing data at 1-week follow-up
Time frame: At 1-week follow-up
Missing data at 1-month follow-up
Time frame: At 1-month follow-up
Missing data at 3-month follow-up
Time frame: At 3-month follow-up
Missing data at 6-month follow-up
Time frame: At 6-month follow-up
Adverse events
Time frame: At the 6 months follow up
Screen rate
Time frame: Immediately after the training workshop
Consent rate
Time frame: Immediately after the training workshop
Eligibility rate
Time frame: Immediately after the training workshop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Yan Ho, Phd principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard treatment and Integrated Intervention in people with Adolescent Behavior, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ka Yan Ho, Phd (27666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The biochemical validation (time frame: At the 6-month follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2021.