- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04599049
Evaluation Study on Smoke-free Teens Programme 2020-2021
The objectives are:
i. To evaluate Smoke-free Teens' change in knowledge on smoking hazards, attitudes towards smoking, tobacco control and smoking cessation, and practices for promoting smoking prevention and cessation, ii. To evaluate the process and quality of smoke-free programmes organized by the Smoke-free Teens in their schools/community, and iii. To measure the number of people reached in the smoke-free programmes organized by the Smoke-free Teens.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Participants Youth between Form 1 and 4 or aged 14 to 18 in the school academic year 2019-2020 will be nominated by secondary schools, youth centres and uniform groups to participate in the Smoke-free Teens Programme 2020-2021.
Outcomes The primary outcomes include the change in (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) the Smoke-free Teens' satisfaction on the training camp.
The secondary outcomes are (1) the number of people participated in the school- or community-based smoke-free programmes organised by the Smoke-free Teens, and (2) the number of smokers advised and referred to existing smoking cessation services by the Smoke-free Teens.
Smoke-free Teens Programme The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by Hong Kong Council on Smoking and Health (COSH). The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation.In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model: 1) Ask about smoking, 2) Warn the smokers that at least half will be killed by smoking, 3) Advise to quit (reduce) as soon as possible, 4) Refer to cessation clinics or hotlines, and 5) Do it again until the smokers quit. By the end of the training camp, the teens should be confident and competent in delivering the brief smoking cessation intervention to smokers. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
Survey instrument A structured questionnaire designed by the smoking cessation team, School of Nursing, the University of Hong Kong will be used to evaluate the training camp. The questionnaire covers four areas, including (1) knowledge on smoking hazards, (2) attitudes towards smoking, tobacco control and smoking cessation, (3) practices for promoting smoking prevention and cessation, and (4) self-efficacy to deliver smoking cessation advices. The items of the questionnaire have been adopted and modified from previous studies on smoking cessation, with well-established psychometric properties. A process evaluation form (Appendix 4) will also be developed by the smoking cessation team to assess how the teens satisfy with the online classes and training camp, and to determine whether the content of online classes and training camp meets the learning needs and expectations of the teens. Table 1 shows the items that will be asked at each time point.
To evaluate the smoke-free programmes organized after the training camp, each group of the Smoke-free Teens will be required to submit a written proposal to COSH. In addition, a final report that contains the information about the number of people reached by the programmes, publicity, and the process and outcomes of the programmes, will be submitted for review.
Data collection Data collection will be conducted by COSH. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). In addition, they will be asked to complete a process evaluation form immediately after the training camp (T3). Comments and suggestions provided by the teens in the process evaluation form will be taken into account for future improvement of the training camp. In addition, each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively.
Statistical analysis The Statistical Package for Social Science (SPSS: Version 23; SPSS Inc., Chicago, IL, USA) for Windows will be employed to analyze the data. Descriptive statistics will be used to describe the demographic characteristics of the Smoke-free Teens. Paired samples t-test and Wilcoxon signed-rank test will be conducted to assess the change in knowledge, attitudes and practices of the Smoke-free Teens regarding smoking, tobacco control and smoking cessation before and after the training camp. To evaluate the smoke-free programmes organized by the Smoke-free Teens after the training camp, descriptive statistics will be used to report the number of people reached by the programmes, publicity, and the process and outcomes of the programmes.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
HK
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Hong Kong, HK, Hong Kong
- William Ho-cheung Li
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria: be able to communicate with Cantonese, nominated by secondary schools, youth centres and uniform groups -
Exclusion Criteria:
-
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: six sessions of online classes and virtual training day camps through Zoom in two days
The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively. |
The Smoke-free teens will join six sessions of online classes via an e-platform in October 2020 and followed by virtual training day camps through Zoom in two days in December 2020 organized by COSH. The online classes will educate students the knowledge on smoking hazards, tobacco control and smoking cessation. In addition, the teens will be taught how to deliver a brief smoking cessation intervention using the "AWARD" Model. After the online classes, the teens will then break down into groups to organize smoke-free programmes in their schools or in the community. All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the online classes (T2), and 3 months later (T4). They will be asked to complete a process evaluation form immediately after the training camp (T3). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 months (T4), respectively. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Conocimiento sobre los peligros de fumar en el nivel de referencia
Periodo de tiempo: Base
|
El conocimiento de los adolescentes libres de humo sobre los peligros del tabaquismo en el nivel inicial se medirá mediante la escala denominada "conocimiento sobre los peligros del tabaquismo" en un cuestionario estructurado de autoinforme.
|
Base
|
|
The change in knowledge on smoking hazards
Periodo de tiempo: Baseline, immediately after the online classes and 3 months
|
The change in Smoke-free Teens' knowledge on smoking hazards immediately after the online classes and 3 months will be measured by the scale called "knowledge on smoking hazards" in a self-reporting structured questionnaire.
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Baseline, immediately after the online classes and 3 months
|
|
Actitudes hacia el tabaquismo, el control del tabaco y el abandono del hábito de fumar en el nivel inicial
Periodo de tiempo: Base
|
Las actitudes de los adolescentes libres de humo hacia el tabaquismo, el control del tabaco y el cese del tabaquismo en el nivel inicial se medirán mediante la escala denominada "actitudes hacia el tabaquismo, el control del tabaco y el cese del tabaquismo" en un cuestionario estructurado de autoinforme.
|
Base
|
|
The change in attitudes towards smoking, tobacco control and smoking cessation
Periodo de tiempo: Baseline, immediately after the online classes and 3 months
|
The change in Smoke-free Teens' attitudes towards smoking, tobacco control and smoking cessation immediately after the online classes and 3 months will be measured by the scale called "attitudes towards smoking, tobacco control and smoking cessation" in a self-reporting structured questionnaire.
|
Baseline, immediately after the online classes and 3 months
|
|
Practices for promoting smoking prevention and cessation at baseline level
Periodo de tiempo: Baseline
|
Smoke-free Teens' practices for promoting smoking prevention and cessation at baseline level will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire
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Baseline
|
|
The change in practices for promoting smoking prevention and cessation
Periodo de tiempo: Baseline and 3 months
|
The change in Smoke-free Teens' practices for promoting smoking prevention and cessation after 3 months will be measured by the scale called "practices for promoting smoking prevention and cessation" in a self-reporting structured questionnaire.
|
Baseline and 3 months
|
|
Autoeficacia para brindar consejos para dejar de fumar al nivel inicial
Periodo de tiempo: Base
|
La autoeficacia de los adolescentes libres de humo para dar consejos para dejar de fumar al nivel inicial se medirá mediante la escala denominada "autoeficacia para dar consejos para dejar de fumar" en un cuestionario estructurado de autoinforme.
|
Base
|
|
The change in self-efficacy to deliver smoking cessation advices
Periodo de tiempo: Baseline, immediately after the online classes and 3 months
|
The change in Smoke-free Teens' self-efficacy to deliver smoking cessation advices immediately after the training camp, after after the online classes and 3 months will be measured by the scale called "self-efficacy to deliver smoking cessation advices" in a self-reporting structured questionnaire.
|
Baseline, immediately after the online classes and 3 months
|
|
Proceso de evaluación del campo de entrenamiento
Periodo de tiempo: inmediatamente después del campo de entrenamiento
|
Los comentarios y puntos de vista de los adolescentes libres de humo sobre el campo de entrenamiento se medirán inmediatamente después del campo de entrenamiento mediante la escala llamada "evaluación del proceso" en un cuestionario estructurado de autoinforme.
|
inmediatamente después del campo de entrenamiento
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The number of people participated in the school- or community-based smoke-free programmes organized by the Smoke-free Teens after the training camp
Periodo de tiempo: 3 months
|
After the online classes, the teens will be required to organize smoke-free programmes in their schools or communities so as to deliver brief smoking cessation intervention and to promote smoke-free messages in their schools and communities.
The number of people participated in these school- or community-based smoke-free programmes will be measured by a final report submitted by the teens that indicate the relevant information.
|
3 months
|
|
The number of smokers advised and referred to existing smoking cessation
Periodo de tiempo: 3 months
|
After the online classes, the teens will organize smoke-free programmes in their schools or in the communities so as to deliver brief smoking cessation intervention and to promote smoke-free messages in their schools and communities.
The number of smokers the teens advised and referred to existing smoking cessation services during these school- or community-based smoke-free programmes will be measured by a final report submitted by the teens that indicate the relevant information.
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: William LI, Phd, School of Nursing, The University of Hong Kong
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- Smoke-free Teens 2020
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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