Risk BehavioursNCT02778139
An Exploratory Study on the Risk Behaviours and Its Associated Psychosocial Factors in Hong Kong Chinese Youth Smokers
An observational study of Risk Behaviours, run by The University of Hong Kong at 1 site in China.
Trial summary
The aims of this study were: (1) to examine the risk behaviours, lifestyle and its associated psychosocial factors for youth smokers; and (2) to explore the relationships among self-esteem, depressive symptoms and quality of life in youth smokers. Read more about this study
- Who is it for?
- Ages 1 year to 25 years
- Conditions the study is for
- Risk Behaviours
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Feb 2017
- Phase
- Observational
- 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 1 year to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: all current youth smokers aged 25 or below in Hong Kong
Who may be able to join
- youth who are aged 25 or below
- smoke at least 1 cigarette in the past 30 days
- able to speak and understand Cantonese.
Who cannot join
- Have difficulty to communicate
Trial locations and contacts
1 site in 1 country.
About this study
The aims of this study were: (1) to examine the risk behaviours, lifestyle and its associated psychosocial factors for youth smokers; and (2) to explore the relationships among self-esteem, depressive symptoms and quality of life in youth smokers.
Read the detailed description
The first approach is to conduct a qualitative interview on 30 youth smokers or until saturation, with the aim to examine the risk behaviours, lifestyle and its associated psychosocial factors for youth smokers.
Participants will be invited to complete a questionnaire on their demographic and socio-economic characteristics. An audiotaped semi-structured interview will then be conducted individually to each participant by two research assistants; with one research assistant will act as the interviewer to encourage the informants to freely express their feelings, thoughts and ideas and another will act as an observer and document any non-verbal language used by the informants. Prior to the data collection, written consent will be obtained from their parents and the participants will be invited to sign the child assent forms.
The second approach is to conduct a quantitative study to compare the self-esteem, depressive symptoms and quality of life between 100 youth smokers and 100 non-smokers.
For the quantitative approach, 100 youth smokers and 100 non-smokers will be recruited through the outreach programme organized by the smoking cessation research team of the School of Nursing. Such programme is a promotional activity to publicise the Youth Quitline and to raise the awareness of no smoking among youth in the community. A structured questionnaire will be used to obtain demographics and socio-economic characteristics of each subject.
Qualitative approach After completing the interviews, the recordings will be fully transcribed, verbatim, in Cantonese to capture nuances of expression unique to the dialect, and selected quotations relevant to the themes will be later translated into English. The analyses begin with an intensive examination of the transcriptions to search for general constructs and themes. Special attention will be given to constructs that diverged from the major topics as framed by the guiding questions.
The transcriptions will be first coded using the open coding method. As the number of codes grew, some closely related codes will be merged, resulting in a smaller, more manageable set of codes. Selective coding will then be adopted to code the transcriptions using the established categories. During the coding process, any inconsistencies in the interpretation of quotations or the assignment of codes will be resolved through discussions with the research team members. Finally, a complete set of codes will be generated to facilitate comparisons and the development of themes and categories.
Quantitative approach Data analysis will be performed using the SPSS, version 20.0 for Windows. The internal consistencies of various instruments used in the study will be determined by calculating their Cronbach. Descriptive statistics will be used to calculate the mean, standard deviation, and range of the scores of the different scales. The relationships among the scores of the CES-DC, RSES, PedsQL v. 4.0 and the participants' age, sex, education attainment, and smoking status will be investigated using the Pearson product-moment correlation coefficient. An independent t-test will be conducted to compare the mean scores of the CES-DC, RSES, PedsQL v. 4.0 between youth smokers and non-smokers.
- Conditions
- Risk Behaviours
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| youth smokers | Not described | |
| non-smokers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Centre for Epidemiologic Studies Depression Scale for Children (CES-DC)
baseline depressive symptoms
Measured: baseline
The Rosenberg's Self-Esteem Scale (RSES)
baseline self-esteem
Measured: baseline
Pediatric Quality-of-life Inventory (PedsQL v. 4.0)
baseline quality of life
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startMay 2016
- Primary completionNov 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk BehavioursStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. LI William Ho Cheung, The University of Hong Kong
- Investigators
- Ho-Cheung Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778139
- Sponsor's protocol ID
- UW 15-218
- Status last verified
- Apr 2017
- First submitted
- 18 May 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on the Risk Behaviours and Its Associated Psychosocial Factors in Hong Kong Chinese Youth Smokers
- ClinicalTrials.gov ID
- NCT02778139
- Acronym / sponsor ID
- UW 15-218
- Conditions
- Risk Behaviours
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 May 2016 (estimated)
- 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.
The aims of this study were: (1) to examine the risk behaviours, lifestyle and its associated psychosocial factors for youth smokers; and (2) to explore the relationships among self-esteem, depressive symptoms and quality of life in youth smokers.
Detailed description
The first approach is to conduct a qualitative interview on 30 youth smokers or until saturation, with the aim to examine the risk behaviours, lifestyle and its associated psychosocial factors for youth smokers.
Participants will be invited to complete a questionnaire on their demographic and socio-economic characteristics. An audiotaped semi-structured interview will then be conducted individually to each participant by two research assistants; with one research assistant will act as the interviewer to encourage the informants to freely express their feelings, thoughts and ideas and another will act as an observer and document any non-verbal language used by the informants. Prior to the data collection, written consent will be obtained from their parents and the participants will be invited to sign the child assent forms.
The second approach is to conduct a quantitative study to compare the self-esteem, depressive symptoms and quality of life between 100 youth smokers and 100 non-smokers.
For the quantitative approach, 100 youth smokers and 100 non-smokers will be recruited through the outreach programme organized by the smoking cessation research team of the School of Nursing. Such programme is a promotional activity to publicise the Youth Quitline and to raise the awareness of no smoking among youth in the community. A structured questionnaire will be used to obtain demographics and socio-economic characteristics of each subject.
Qualitative approach After completing the interviews, the recordings will be fully transcribed, verbatim, in Cantonese to capture nuances of expression unique to the dialect, and selected quotations relevant to the themes will be later translated into English. The analyses begin with an intensive examination of the transcriptions to search for general constructs and themes. Special attention will be given to constructs that diverged from the major topics as framed by the guiding questions.
The transcriptions will be first coded using the open coding method. As the number of codes grew, some closely related codes will be merged, resulting in a smaller, more manageable set of codes. Selective coding will then be adopted to code the transcriptions using the established categories. During the coding process, any inconsistencies in the interpretation of quotations or the assignment of codes will be resolved through discussions with the research team members. Finally, a complete set of codes will be generated to facilitate comparisons and the development of themes and categories.
Quantitative approach Data analysis will be performed using the SPSS, version 20.0 for Windows. The internal consistencies of various instruments used in the study will be determined by calculating their Cronbach. Descriptive statistics will be used to calculate the mean, standard deviation, and range of the scores of the different scales. The relationships among the scores of the CES-DC, RSES, PedsQL v. 4.0 and the participants' age, sex, education attainment, and smoking status will be investigated using the Pearson product-moment correlation coefficient. An independent t-test will be conducted to compare the mean scores of the CES-DC, RSES, PedsQL v. 4.0 between youth smokers and non-smokers.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| youth smokers | – | – |
| non-smokers | – | – |
Who may qualify
- Ages
- 1 year to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all current youth smokers aged 25 or below in Hong Kong
Key inclusion criteria (3 listed)
- youth who are aged 25 or below
- smoke at least 1 cigarette in the past 30 days
- able to speak and understand Cantonese.
Key exclusion criteria (1 listed)
- Have difficulty to communicate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Centre for Epidemiologic Studies Depression Scale for Children (CES-DC)
Time frame: baseline
baseline depressive symptoms
The Rosenberg's Self-Esteem Scale (RSES)
Time frame: baseline
baseline self-esteem
Pediatric Quality-of-life Inventory (PedsQL v. 4.0)
Time frame: baseline
baseline quality of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- 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.
Ho-Cheung Li, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Risk Behaviours, run by The University of Hong Kong at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 5 Apr 2017. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Centre for Epidemiologic Studies Depression Scale for Children (CES-DC) (time frame: baseline). The study lists 3 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 5 Apr 2017.