- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02778139
An Exploratory Study on the Risk Behaviours and Its Associated Psychosocial Factors in Hong Kong Chinese Youth Smokers
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Hong Kong SAR, Cina
- The University of Hong Kong
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Caso di controllo
- Prospettive temporali: Trasversale
Coorti e interventi
Gruppo / Coorte |
|---|
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youth smokers
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non-smokers
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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The Centre for Epidemiologic Studies Depression Scale for Children (CES-DC)
Lasso di tempo: baseline
|
baseline depressive symptoms
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baseline
|
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The Rosenberg's Self-Esteem Scale (RSES)
Lasso di tempo: baseline
|
baseline self-esteem
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baseline
|
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Pediatric Quality-of-life Inventory (PedsQL v. 4.0)
Lasso di tempo: baseline
|
baseline quality of life
|
baseline
|
Collaboratori e investigatori
Sponsor
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Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- UW 15-218
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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