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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

China1 site
  • The University of Hong Kong

    Hong Kong SAR

Other trials in China

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 groups in NCT02778139
Study groupRoleWhat they receive
youth smokersNot described
non-smokersNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Centre for Epidemiologic Studies Depression Scale for Children (CES-DC)

    baseline depressive symptoms

    Measured: baseline

  2. The Rosenberg's Self-Esteem Scale (RSES)

    baseline self-esteem

    Measured: baseline

  3. 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.

  1. First posted19 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionNov 2016
  4. Study completionFeb 2017

Resources

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)
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

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.

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