Process and Effect Evaluation of the KickAsh! Intervention

Study Overview
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Brief Summary
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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).

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

Conditions
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Smoking Cigarette, Smoking Tobacco, Smoking, Smoking Prevention

Intervention / Treatment
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* Behavioral: KickAsh! intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two-arm non-randomized controlled trail with a mixed-methods approach will be conducted. Youth social work organisations will be assigned to one of the two groups: 1. one group will receive the intervention (intervention group), 2. another group will not receive the intervention (control group). Measurements will take place in both groups at the same time.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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. | Behavioral: KickAsh! intervention<br>* The general aim of the KickAsh! intervention is to prevent smoking initiation in adolescents living in vulnerable socioeconomic situations. The intervention exists of different components concerning smoking prevention. Most components have a direct influence on smoking initiation by affecting several determinants of the adolescents. These components include smoke-free games, mood boards, a smoke-free camp, the Kick some Ash!-challenge and exercises concerning self-efficacy and skills. Yet, some of the components target adolescents by influencing their environment, i.e. smoking policy in the organisation and youth workers as role models. All components are developed using a combination of theoretical methods to change or influence these determinants or environmental factors.<br>|
| No Intervention: Control group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in smoking initiation behaviour 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. | From enrollment to the end of intervention implementation at 3 months | 
| Change in smoking initiation behaviour at 6 months follow-up | 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. | From end of intervention implementation to follow-up measurement after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in attitude towards smoking at 3 months | 8 items will be assessed: 4 items for cognitive and 4 items for emotional (dis)advantages of smoking. Adolescents will have to answer using a five-point likert scale. | From enrollment to the end of intervention implementation at 3 months | 
| Change in attitude towards smoking at 6 months follow-up | 8 items will be assessed: 4 items for cognitive and 4 items for emotional (dis)advantages of smoking. Adolescents will have to answer using a five-point likert scale. | From end of intervention implementation to follow-up measurement after 6 months | 
| Change in self-efficacy concerning smoking at 3 months | Self-efficacy will be measured via 6 questions measuring the ability to resist smoking in several situations (5-point likert scale). These questions will be linked to 6 coping plan items. | From enrollment to the end of intervention implementation at 3 months | 
| Change in self-efficacy concerning smoking at 6 months follow-up | Self-efficacy will be measured via 6 questions measuring the ability to resist smoking in several situations (5-point likert scale). These questions will be linked to 6 coping plan items. | From end of intervention implementation to follow-up measurement after 6 months | 
| Change in social influence concerning smoking at 3 months | Social influence will be measured by assessing perceived social norm (7 questions determining the perceptions of important people in the adolescent's environment) and social pressure (7 items determining the pressure felt by adolescents by the same important people). Both via a 5-point likert scale. | From enrollment to the end of intervention implementation at 3 months | 
| Change in social influence concerning smoking at 6 months follow-up | Social influence will be measured by assessing perceived social norm (7 questions determining the perceptions of important people in the adolescent's environment) and social pressure (7 items determining the pressure felt by adolescents by the same important people). Both via a 5-point likert scale. | From end of intervention implementation to follow-up measurement after 6 months | 
| Impact of context on study effects during implementation | Context of the youth social work organisations will be analysed through interviews and focus groups with respectively adolescents and youth workers. | From enrollment to the end of intervention implementation at 3 months | 
| Mechanisms of impact concerning the delivered intervention | Mechanisms of impact will be analysed through interviews and focus groups with respectively adolescents and youth workers. | From enrollment to the end of intervention implementation at 3 months | 
| Impact of implementation process on the delivered intervention | Implementation process (how was it delivered, feasibility, barriers and facilitators...) will be analysed through interviews and focus groups with respectively adolescents and youth workers. | From enrollment to the end of intervention implementation at 3 months | 
| Impact of delivered intervention on the study effects | What is delivered (fidelity, reach, dose, adaptations) will be analysed through interviews and focus groups with respectively adolescents and youth workers. | From enrollment to the end of intervention implementation at 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Prevention, RCT-study, Tobacco smoking, Cigarette smoking, Smoking, Smoking initiation, Smoking Start, Smoking onset, adolescents, youth work, low SES, socioeconomic status, vulnerable, evaluation, effect evaluation, process evaluation, co-creation, intervention