- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02778139
An Exploratory Study on the Risk Behaviours and Its Associated Psychosocial Factors in Hong Kong Chinese Youth Smokers
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Hong Kong SAR, Kina
- The University of Hong Kong
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- youth who are aged 25 or below
- smoke at least 1 cigarette in the past 30 days
- able to speak and understand Cantonese.
Exclusion Criteria:
- Have difficulty to communicate
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
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youth smokers
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non-smokers
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The Centre for Epidemiologic Studies Depression Scale for Children (CES-DC)
Tidsramme: baseline
|
baseline depressive symptoms
|
baseline
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The Rosenberg's Self-Esteem Scale (RSES)
Tidsramme: baseline
|
baseline self-esteem
|
baseline
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Pediatric Quality-of-life Inventory (PedsQL v. 4.0)
Tidsramme: baseline
|
baseline quality of life
|
baseline
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- UW 15-218
Plan for individuelle deltakerdata (IPD)
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