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

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 Overview

• Status: Recruiting
• Conditions: Smoking; Smoking Tobacco; Smoking Prevention; Smoking Cigarette
• Intervention / Treatment: Behavioral: KickAsh! intervention

• Study Type: Interventional
• Enrollment (Estimated): 720
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Babette Demeester, MSc.; Phone Number: +32494348040; Email: babette.demeester@ugent.be
• Study Contact Backup: Name: Kenji Leta, MSc.; Email: kenji.leta@ugent.be

Study Locations

• Belgium
  • Ghent, Belgium
    • Recruiting
    • University Ghent
    • Contact: Kenji Leta; Email: kenji.leta@ugent.be
    • Contact: Babette Demeester; Email: babdmees.demeester@ugent.be
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • Not yet recruiting
      • University Ghent
      • Contact: Babette Demeester; Phone Number: +32494348040; Email: babette.demeester@ugent.be
      • Contact: Kenji Leta; Email: kenji.leta@ugent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Maïté Verloigne, Prof. dr., University Ghent

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2023
• Primary Completion (Estimated): July 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Smoking; intervention; adolescents; evaluation; low SES; Cigarette smoking; Tobacco smoking; process evaluation; socioeconomic status; Smoking Prevention; effect evaluation; vulnerable; RCT-study; Smoking initiation; Smoking Start; Smoking onset; youth work; co-creation
• Other Study ID Numbers: ONZ-2023-0366

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data collection will take place from September 2023 until July 2024, afterwards data will be pseudonymised and shared. Pseudonymised data will be available for the research group Health Promotion (Ghent University) for at least 10 years, to support an open science view.
• IPD Sharing Access Criteria: Everyone who possess the URL and login details can access the pseudonymised data files (which are stored on a protected data base from Ghent University).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No