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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05920772
Other study ID # ONZ-2023-0366
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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