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Process and Effect Evaluation of the KickAsh! Intervention

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05920772
Enrollment
720
Registered
2023-06-27
Start date
2023-10-04
Completion date
2024-10-31
Last updated
2024-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking, Smoking Cigarette, Smoking Prevention, Smoking Tobacco

Keywords

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

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).

Interventions

BEHAVIORALKickAsh! intervention

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.

Sponsors

University Ghent
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
10 Years to 15 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change in smoking initiation behaviour at 3 monthsFrom enrollment to the end of intervention implementation at 3 monthsSmoking 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-upFrom end of intervention implementation to follow-up measurement after 6 monthsSmoking 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

MeasureTime frameDescription
Change in self-efficacy concerning smoking at 3 monthsFrom enrollment to the end of intervention implementation at 3 monthsSelf-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.
Change in self-efficacy concerning smoking at 6 months follow-upFrom end of intervention implementation to follow-up measurement after 6 monthsSelf-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.
Change in social influence concerning smoking at 3 monthsFrom enrollment to the end of intervention implementation at 3 monthsSocial 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.
Change in social influence concerning smoking at 6 months follow-upFrom end of intervention implementation to follow-up measurement after 6 monthsSocial 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.
Change in attitude towards smoking at 3 monthsFrom enrollment to the end of intervention implementation at 3 months8 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.
Mechanisms of impact concerning the delivered interventionFrom enrollment to the end of intervention implementation at 3 monthsMechanisms of impact will be analysed through interviews and focus groups with respectively adolescents and youth workers.
Impact of implementation process on the delivered interventionFrom enrollment to the end of intervention implementation at 3 monthsImplementation process (how was it delivered, feasibility, barriers and facilitators...) will be analysed through interviews and focus groups with respectively adolescents and youth workers.
Impact of delivered intervention on the study effectsFrom enrollment to the end of intervention implementation at 3 monthsWhat is delivered (fidelity, reach, dose, adaptations) will be analysed through interviews and focus groups with respectively adolescents and youth workers.
Impact of context on study effects during implementationFrom enrollment to the end of intervention implementation at 3 monthsContext of the youth social work organisations will be analysed through interviews and focus groups with respectively adolescents and youth workers.
Change in attitude towards smoking at 6 months follow-upFrom end of intervention implementation to follow-up measurement after 6 months8 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.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026