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NCT Number: NCT05920772

Process and Effect Evaluation of the KickAsh! Intervention

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Smoking Cigarette Behavior Cigarette Smoking Smoking Smoking Prevention Smoking Tobacco Tobacco Smoking Tobacco Use

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Ghent, Ghent, Oost-Vlaanderen, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KickAsh! intervention

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  1. Change in attitude towards smoking at 3 months

    Time frame: From enrollment to the end of intervention implementation 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.

  2. Change in attitude towards smoking at 6 months follow-up

    Time frame: From end of intervention implementation to follow-up measurement after 6 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.

  3. Change in self-efficacy concerning smoking at 3 months

    Time frame: From enrollment to the end of intervention implementation 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.

  4. Change in self-efficacy concerning smoking at 6 months follow-up

    Time frame: From end of intervention implementation to follow-up measurement after 6 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.

  5. Change in social influence concerning smoking at 3 months

    Time frame: From enrollment to the end of intervention implementation 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.

  6. Change in social influence concerning smoking at 6 months follow-up

    Time frame: From end of intervention implementation to follow-up measurement after 6 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.

  7. Impact of context on study effects during implementation

    Time frame: From enrollment to the end of intervention implementation at 3 months

    Context of the youth social work organisations will be analysed through interviews and focus groups with respectively adolescents and youth workers.

  8. Mechanisms of impact concerning the delivered intervention

    Time frame: From enrollment to the end of intervention implementation at 3 months

    Mechanisms of impact will be analysed through interviews and focus groups with respectively adolescents and youth workers.

  9. Impact of implementation process on the delivered intervention

    Time frame: From enrollment to the end of intervention implementation at 3 months

    Implementation process (how was it delivered, feasibility, barriers and facilitators...) will be analysed through interviews and focus groups with respectively adolescents and youth workers.

  10. Impact of delivered intervention on the study effects

    Time frame: From enrollment to the end of intervention implementation at 3 months

    What is delivered (fidelity, reach, dose, adaptations) will be analysed through interviews and focus groups with respectively adolescents and youth workers.

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2023
Registry last updated
Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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