Process and Effect Evaluation of the KickAsh! Intervention

NCT05920772 | Active Not Recruiting

• 1 other identifier: ONZ-2023-0366
• Study Type: interventional
• Target: 720
• Locations: 1 country
• Sites: 2

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).

Conditions

Smoking Cigarette; Smoking Tobacco; Smoking; Smoking Prevention

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Change in attitude towards smoking at 3 months

  From enrollment to the end of intervention implementation at 3 months

• Change in attitude towards smoking at 6 months follow-up

  From end of intervention implementation to follow-up measurement after 6 months

• Change in self-efficacy concerning smoking at 3 months

  From enrollment to the end of intervention implementation at 3 months

• Change in self-efficacy concerning smoking at 6 months follow-up

  From end of intervention implementation to follow-up measurement after 6 months

• Change in social influence concerning smoking at 3 months

  From enrollment to the end of intervention implementation at 3 months

Study Arms (2)

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.

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.

Interventions

KickAsh! intervention BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Not participating in a youth social work organisation

Sponsors & Collaborators

• University Ghent: lead

Study Sites (2)

University Ghent

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

University Ghent

Ghent, Belgium

Location

Related Publications (2)

• 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.

  PMID: 37202340 BACKGROUND

• Demeester 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.

  PMID: 38481024 DERIVED

MeSH Terms

Conditions

Cigarette Smoking; Smoking; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior; Tobacco Use

Study Officials

• Maïté Verloigne, Prof. dr.

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: October 4, 2023
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: July 16, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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).

Locations

BE (2)