Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents

Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01602796

Acronym

ITACA

Enrollment

2226

Registered

2012-05-21

Start date

2011-09-30

Completion date

2020-09-30

Last updated

2021-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Brief summary

In this multicenter cluster randomized controlled trial stratified by school baseline prevalence of smoking will be randomly allocated to the control or intervention group. Control schools will receive normal smoking education and intrvention schools will receive a four year class-based curriculum intervention (22 Classroom lessons), reinforcement of smoke-free school policy, smoking cessation in parents, pupils, and teachers and information and annual meeting with parents. Study participants will be children aged 12 to 15 years old ; they will be followed to 2 years after high school. External evaluator and analyst will be blinded to school allocation. The aim of this study is to analyze the effectiveness of a complex intervention to reduce the prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old) .

Interventions

BEHAVIORALSchool intervention

The ITACA intervention is a cognitive and social-influences approach to prevent tobacco consumption. The intervention is integrated in the curricula of the school, also schools are reinforced to follow a smoke-free school and strictly follow legislation about smoking in schools. The community component include annual meeting with adolescents parents and parents and teachers intensive group for smoking cessation.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

11 Years to 14 Years

Healthy volunteers

Inclusion criteria

* Children at first of Secondary education. * Adolescents and parents accept and sign informed consent

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Smoking prevalence of adolescents in each group	six years	We will compare the smoking prevalence of adolescents in each group at six years against the usual null hypothesis of no difference between groups. We will use the Chi-squared test, taking into account the variance inflation factor of the adolescent cluster and intraclass correlation coefficient.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026