Clinical trial NCT05920772: Process and Effect Evaluation of the KickAsh! Intervention
Official title: Preventing Smoking Initiation in Adolescents Living in Vulnerable Socioeconomic Situations: a Study Protocol of the KickAsh! Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 720
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change in smoking initiation behaviour at 3 months
timeFrame: From enrollment to the end of intervention implementation at 3 months
measure: Change in smoking initiation behaviour at 6 months follow-up
timeFrame: From end of intervention implementation to follow-up measurement after 6 months
Secondary outcomes:
measure: Change in attitude towards smoking at 3 months
timeFrame: From enrollment to the end of intervention implementation at 3 months
measure: Change in attitude towards smoking at 6 months follow-up
timeFrame: From end of intervention implementation to follow-up measurement after 6 months
measure: Change in self-efficacy concerning smoking at 3 months
timeFrame: From enrollment to the end of intervention implementation at 3 months
measure: Change in self-efficacy concerning smoking at 6 months follow-up
timeFrame: From end of intervention implementation to follow-up measurement after 6 months
measure: Change in social influence concerning smoking at 3 months
timeFrame: From enrollment to the end of intervention implementation at 3 months
measure: Change in social influence concerning smoking at 6 months follow-up
timeFrame: From end of intervention implementation to follow-up measurement after 6 months
measure: Impact of context on study effects during implementation
timeFrame: From enrollment to the end of intervention implementation at 3 months
measure: Mechanisms of impact concerning the delivered intervention
timeFrame: From enrollment to the end of intervention implementation at 3 months
measure: Impact of implementation process on the delivered intervention
timeFrame: From enrollment to the end of intervention implementation at 3 months
measure: Impact of delivered intervention on the study effects
timeFrame: From enrollment to the end of intervention implementation at 3 months
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent
state: Oost-Vlaanderen
city: Ghent
country: Belgium
facility: University Ghent
Study officials:
affiliation: University Ghent
name: Maïté Verloigne, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.