Process and Effect Evaluation of the KickAsh! Intervention

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920772
• Other study ID #: ONZ-2023-0366
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: January 2024
• Source: University Ghent
• Contact: Babette Demeester, MSc.
• Phone: +32494348040
• Email: babette.demeester[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking
• Smoking Prevention
• Smoking Tobacco

Intervention

Behavioral:
• KickAsh! 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.

Locations

Country	Name	City	State
Belgium	University Ghent	Ghent	Oost-Vlaanderen
Belgium	University Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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