Mental Health IssueNCT05148520
Provision of Service of a YQL Programme For Youth Smokers
A study testing 5A's model in people with Mental Health Issue, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This project is funded by Department of Health. We will run a quitline which provides telephone smoking cessation counseling to youth smokers aged 25 or below. After baseline counseling based on trans-theoretical model, follow-up counseling will be provided by trained counselors (i.e. Read more about this study
- Who is it for?
- Ages Up to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- 5A's model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2020to 1 Dec 2022
- 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 Up to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 25 or below
- Self-reported to smoke any types of tobacco products within the past 1 month
- Speak Cantonese and
- Provide verbal consent to counselling service.
Who cannot join
- have psychiatric disease
- and/or currently receive any smoking cessation intervention from other service providers
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Ka Yan Ho
Hong Kong, Hong Kong,China, 0000
Ka Yan Ho, Phd, 27666417, kyeva.ho@polyu.edu.hk
About this study
Official title: Provision of Service of a Youth Quitline Programme For Youth Smokers
This project is funded by Department of Health. We will run a quitline which provides telephone smoking cessation counseling to youth smokers aged 25 or below. After baseline counseling based on trans-theoretical model, follow-up counseling will be provided by trained counselors (i.e. nursing students or students from other healthrelated disciplines) at 1 week, 1, 3, 6, 9 and 12 months. It is expected that the quitline can assist youth smokers to quit smoking, thus saving the healthcare cost attributed to smoking in long-term.
Read the detailed description
This project will last for 15 months (from 1st Dec 2020 to 28th Feb 2022). Prior to commencement, a month will be spent on preparation, including setting up the quitline and website, designing and printing publicity materials, connecting with secondary and post-secondary schools and training peer counsellors. We will operate the quitline for 15 months and provide telephone counselling for eligible youth smokers. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.
- Conditions
- Mental Health Issue
- Being tested
- 5A's model
- Keywords
- smoking cessation service, youth smoker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5A's modelBehavioural
(1) Ask - ask youth smokers about their smoking habit, (2) Advise - advise youth smokers to quit smoking, (3) Assess - assess youth smokers about their willingness to quit smoking, (4) Assist - assist youth smokers who are willing to make a quit attempt, and (5) Arrange
- arrange for follow-up.
| Study group | Role | What they receive |
|---|---|---|
| 5A's model | Other | The practice guideline emphasizes on the use of '5A's' model that contains five major steps in providing smoking cessation counselling. Specifically, our counsellors will take the following steps to provide telephone counselling for youth smokers who are ready to quit smoking Receives: Behavioral: 5A's model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported 7-point prevalence
The self-reported abstinence will be validated if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests.
Measured: at the 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start1 Nov 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT05148520
- Sponsor's protocol ID
- YQL
- Status last verified
- Nov 2021
- First submitted
- 25 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provision of Service of a Youth Quitline Programme For Youth Smokers
- ClinicalTrials.gov ID
- NCT05148520
- Acronym / sponsor ID
- YQL
- Conditions
- Mental Health Issue
- Keywords
- smoking cessation service, youth smoker
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 8 Dec 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.
This project is funded by Department of Health. We will run a quitline which provides telephone smoking cessation counseling to youth smokers aged 25 or below. After baseline counseling based on trans-theoretical model, follow-up counseling will be provided by trained counselors (i.e. nursing students or students from other healthrelated disciplines) at 1 week, 1, 3, 6, 9 and 12 months. It is expected that the quitline can assist youth smokers to quit smoking, thus saving the healthcare cost attributed to smoking in long-term.
Detailed description
This project will last for 15 months (from 1st Dec 2020 to 28th Feb 2022). Prior to commencement, a month will be spent on preparation, including setting up the quitline and website, designing and printing publicity materials, connecting with secondary and post-secondary schools and training peer counsellors. We will operate the quitline for 15 months and provide telephone counselling for eligible youth smokers. Self-reported quitters at 6-month follow-up will be invited for biochemical validation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 5A's model | Other | Behavioral: 5A's modelThe practice guideline emphasizes on the use of '5A's' model that contains five major steps in providing smoking cessation counselling. Specifically, our counsellors will take the following steps to provide telephone counselling for youth smokers who are ready to quit smoking |
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 25 or below
- Self-reported to smoke any types of tobacco products within the past 1 month
- Speak Cantonese and
- Provide verbal consent to counselling service.
Key exclusion criteria (2 listed)
- have psychiatric disease
- and/or currently receive any smoking cessation intervention from other service providers
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 |
|---|---|---|
| 5A's model(1) Ask - ask youth smokers about their smoking habit, (2) Advise - advise youth smokers to quit smoking, (3) Assess - assess youth smokers about their willingness to quit smoking, (4) Assist - assist youth smokers who are willing to make a quit attempt, and (5) Arrange - arrange for follow-up. | Behavioural | 5A's model |
Primary outcome
Self-reported 7-point prevalence
Time frame: at the 6-month follow-up
The self-reported abstinence will be validated if the level of carbon monoxide in expired air was less than 4 parts per million and saliva cotinine level was less than100 ng/mL in parallel tests.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
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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 5A's model in people with Mental Health Issue, 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 4 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 8 Dec 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. 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?
Self-reported 7-point prevalence (time frame: at the 6-month follow-up). 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 8 Dec 2021.