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临床试验/NCT05920772
NCT05920772进行中(未招募)不适用

Preventing Smoking Initiation in Adolescents Living in Vulnerable Socioeconomic Situations: a Study Protocol of the KickAsh! Intervention

University Ghent2 个研究点 分布在 1 个国家目标入组 720 人开始时间: 2023年10月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
720
试验地点
2
主要终点
Change in smoking initiation behaviour at 3 months

研究概览

简要总结

The goal of this evaluation study is to evaluate the KickAsh! intervention, an intervention aiming to prevent smoking initiation in adolescents living in vulnerable socioeconomic situations. This intervention will be implemented in youth social work organisation that offer sport and/or recreational activities for these adolescents. Youth workers will act as implementers of the intervention.

The main aim of this study is to evaluate the effect of the intervention, whether it does or does not produce change in the smoking initiation behaviour of adolescents (= effect evaluation). Secondly, the study aims to evaluate the implementation process to generate more understanding concerning why the intervention does or does not produces change. Therefore, it will be investigated how the intervention was implemented, what exactly was implemented, in which context the intervention was implemented... (= process evaluation)

For the effect evaluation adolescents will be asked to fill in a questionaire at three time points. For the process evaluations interviews and focus groups will be organised with the adolescents and youth workers respectively.

Two groups will participate to this study: one group existing of organisations where the intervention will be implemented (=intervention group), and one group where the intervention will not be implemented (= control group).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aged between 10 and 15 years old
  • Participate in activities offered by a youth social work organisation during the implementation period
  • Have sufficient understanding of the Dutch language

排除标准

  • Not participating in a youth social work organisation

结局指标

主要结局

Change in smoking initiation behaviour at 3 months

时间窗: From enrollment to the end of intervention implementation at 3 months

Smoking initiation will be measured following MUSICA: the Model of Unplanned Smoking Initiation of Children and Adolescents. In addition, two questions will be asked concerning smoking frequency in the past month and in adolescents life. Smoking onset age and smoking intention in the following year an d the future are also questioned.

Change in smoking initiation behaviour at 6 months follow-up

时间窗: From end of intervention implementation to follow-up measurement after 6 months

Smoking initiation will be measured following MUSICA: the Model of Unplanned Smoking Initiation of Children and Adolescents. In addition, two questions will be asked concerning smoking frequency in the past month and in adolescents life. Smoking onset age and smoking intention in the following year an d the future are also questioned.

次要结局

  • Change in self-efficacy concerning smoking at 3 months(From enrollment to the end of intervention implementation at 3 months)
  • Change in attitude towards smoking at 6 months follow-up(From end of intervention implementation to follow-up measurement after 6 months)
  • Impact of implementation process on the delivered intervention(From enrollment to the end of intervention implementation at 3 months)
  • Change in attitude towards smoking at 3 months(From enrollment to the end of intervention implementation at 3 months)
  • Impact of delivered intervention on the study effects(From enrollment to the end of intervention implementation at 3 months)
  • Change in self-efficacy concerning smoking at 6 months follow-up(From end of intervention implementation to follow-up measurement after 6 months)
  • Change in social influence concerning smoking at 3 months(From enrollment to the end of intervention implementation at 3 months)
  • Mechanisms of impact concerning the delivered intervention(From enrollment to the end of intervention implementation at 3 months)
  • Change in social influence concerning smoking at 6 months follow-up(From end of intervention implementation to follow-up measurement after 6 months)
  • Impact of context on study effects during implementation(From enrollment to the end of intervention implementation at 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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