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Clinical Trials/NCT05920772
NCT05920772Active, not recruitingNot Applicable

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

University Ghent2 sites in 1 country720 target enrollmentStarted: October 4, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
720
Locations
2
Primary Endpoint
Change in smoking initiation behaviour at 3 months

Study Overview

Brief Summary

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
10 Years to 15 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Exclusion Criteria

  • •Not participating in a youth social work organisation

Arms & Interventions

Intervention group

Experimental

A smoking initiation prevention intervention (called KickAsh! intervention) will be implemented in 12 youth social work organisations offering sport and/or recreational activities, during a period of three months (October 2023 to December 2023).Youth workers will act as implementers of the intervention. Approximately 5 youth workers per organisation will participate in the study. Adolescents participating in the youth social work organisations will receive the intervention. Approximately 25 adolescents per organisation will participate in the study.

Intervention: KickAsh! intervention (Behavioral)

Control group

No Intervention

12 other youth social work organisations offering sport and/or recreational activities will be allocated to the control group. This group will not receive the KickAsh! intervention. Approximately 5 youth workers per organisation will participate in the study. Approximately 25 adolescents per organisation will participate in the study.

Outcomes

Primary Outcomes

Change in smoking initiation behaviour at 3 months

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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