Smoking CigaretteNCT05920772
Process and Effect Evaluation of the KickAsh! Intervention
A study testing KickAsh! intervention in people with Smoking Cigarette and Smoking Tobacco, run by University Ghent at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cigarette, Smoking Tobacco, Smoking
- What is being tested?
- KickAsh! intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 720 participants
- Where
- 2 sitesBelgium
- Study dates
- 4 Oct 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Not participating in a youth social work organisation
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Ghent
Ghent, Oost-Vlaanderen, 9000
University Ghent
Ghent
About this study
Official title: Preventing Smoking Initiation in Adolescents Living in Vulnerable Socioeconomic Situations: a Study Protocol 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)
Read more
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).
- Conditions
- Smoking Cigarette, Smoking Tobacco, Smoking, Smoking Prevention
- Being tested
- KickAsh! intervention
- 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
- Medical subject headings
- Cigarette Smoking, Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KickAsh! interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: KickAsh! intervention |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From end of intervention implementation to follow-up measurement after 6 months
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of intervention implementation at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start4 Oct 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking CigaretteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 720 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maïté Verloigne, Prof. dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920772
- Sponsor's protocol ID
- ONZ-2023-0366
- Status last verified
- Jul 2024
- First submitted
- 16 Jun 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymised data might be shared with researchers from the research group Health Promotion (Ghent University) for secondary data analyses or teaching purposes. However, participants must re-consent for the use of their data in a new research project and domain.
Publications
Leta K, Lauwerier E, Willems S, Vermeersch S, Demeester B, Verloigne M. Smoking prevention within social work organizations: a qualitative study about youngsters' and youth workers' perceptions. Health Promot Int. 2023 Jun 1;38(3):daad047. doi: 10.1093/heapro/daad047.
PubMed 37202340Demeester B, Willems S, Leta K, Stevens PAJ, Verloigne M, Lauwerier E. Preventing smoking initiation among vulnerable adolescents: a process evaluation of the KickAsh!-intervention in Flemish youth social work settings. Arch Public Health. 2026 Jun 5;84(1):180. doi: 10.1186/s13690-026-01972-6.
PubMed 42243974Demeester B, Verloigne M, Willems S, Leta K, Lauwerier E. Preventing smoking initiation in adolescents living in vulnerable socioeconomic conditions: Study protocol of the KickAsh!-intervention. Scand J Public Health. 2025 May;53(3):330-341. doi: 10.1177/14034948241236232. Epub 2024 Mar 13.
PubMed 38481024
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Smoking Initiation in Adolescents Living in Vulnerable Socioeconomic Situations: a Study Protocol of the KickAsh! Intervention
- ClinicalTrials.gov ID
- NCT05920772
- Acronym / sponsor ID
- ONZ-2023-0366
- Conditions
- Smoking Cigarette, Smoking Tobacco, Smoking, Smoking Prevention
- Keywords
- Smoking Prevention, RCT-study, Tobacco smoking, Cigarette smoking, Smoking, Smoking initiation, Smoking Start, Smoking onset
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 720 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: KickAsh! interventionA 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. |
| 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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Not participating in a youth social work organisation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KickAsh! interventionThe 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. | Behavioural | Intervention group |
Primary outcome
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.
10 secondary outcomes
Change in attitude towards smoking at 3 months
Time frame: From enrollment to the end of intervention implementation at 3 months
Change in attitude towards smoking at 6 months follow-up
Time frame: From end of intervention implementation to follow-up measurement after 6 months
Change in self-efficacy concerning smoking at 3 months
Time frame: From enrollment to the end of intervention implementation at 3 months
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
Change in social influence concerning smoking at 3 months
Time frame: From enrollment to the end of intervention implementation at 3 months
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
Impact of context on study effects during implementation
Time frame: From enrollment to the end of intervention implementation at 3 months
Mechanisms of impact concerning the delivered intervention
Time frame: From enrollment to the end of intervention implementation at 3 months
Impact of implementation process on the delivered intervention
Time frame: From enrollment to the end of intervention implementation at 3 months
Impact of delivered intervention on the study effects
Time frame: From enrollment to the end of intervention implementation at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Background: PubMed 37202340Leta K, Lauwerier E, Willems S, Vermeersch S, Demeester B, Verloigne M. Smoking prevention within social work organizations: a qualitative study about youngsters' and youth workers' perceptions. Health Promot Int. 2023 Jun 1;38(3):daad047. doi: 10.1093/heapro/daad047.
- Derived from this study: PubMed 42243974Demeester B, Willems S, Leta K, Stevens PAJ, Verloigne M, Lauwerier E. Preventing smoking initiation among vulnerable adolescents: a process evaluation of the KickAsh!-intervention in Flemish youth social work settings. Arch Public Health. 2026 Jun 5;84(1):180. doi: 10.1186/s13690-026-01972-6.
- Derived from this study: PubMed 38481024Demeester B, Verloigne M, Willems S, Leta K, Lauwerier E. Preventing smoking initiation in adolescents living in vulnerable socioeconomic conditions: Study protocol of the KickAsh!-intervention. Scand J Public Health. 2025 May;53(3):330-341. doi: 10.1177/14034948241236232. Epub 2024 Mar 13.
- Individual participant dataSharing planned: Yes. Pseudonymised data might be shared with researchers from the research group Health Promotion (Ghent University) for secondary data analyses or teaching purposes. However, participants must re-consent for the use of their data in a new research project and domain.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maïté Verloigne, Prof. dr. principal investigator
University Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KickAsh! intervention in people with Smoking Cigarette and Smoking Tobacco, run by University Ghent at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in smoking initiation behaviour at 3 months (time frame: From enrollment to the end of intervention implementation at 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920772, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.