Process and Effect Evaluation of the KickAsh! Intervention

Sponsor
University Ghent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05920772
Collaborator
(none)
720
1
2
13
55.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: KickAsh! intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
720 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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)
Primary Purpose:
Prevention
Official Title:
Preventing Smoking Initiation in Adolescents Living in Vulnerable Socioeconomic Situations: a Study Protocol of the KickAsh! Intervention
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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.

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.

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

  1. Change in smoking initiation behaviour at 3 months [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 [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 Outcome Measures

  1. Change in attitude towards smoking at 3 months [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years to 15 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Ghent Ghent Oost-Vlaanderen Belgium 9000

Sponsors and Collaborators

  • University Ghent

Investigators

  • Principal Investigator: Maïté Verloigne, Prof. dr., University Ghent
  • Principal Investigator: Emelien Lauwerier, Prof. dr., University Ghent
  • Principal Investigator: Sara Willems, Prof. dr., University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT05920772
Other Study ID Numbers:
  • Grant number 12339
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 29, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Ghent

Study Results

No Results Posted as of Jun 29, 2023