Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents (ITACA)

March 9, 2021 updated by: Fundació d'investigació Sanitària de les Illes Balears

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

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) .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2226

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Baleare
      • Muro, Baleare, Spain, 07440
        • IES Albuhaira
    • Baleares
      • Alaior, Baleares, Spain, 07340
        • IES Josep Miquel Guardia
      • Alcudia, Baleares, Spain, 07410
        • IES Alcudia
      • Andratx, Baleares, Spain, 07150
        • IES Baltasar Porcel
      • Artà, Baleares, Spain, 07057
        • IES Llorenç Garcias i Font
      • Calvia, Baleares, Spain, 07181
        • IES Son Ferrer
      • Capdepera, Baleares, Spain, 07580
        • IES Capdepera
      • Ciudadela, Baleares, Spain, 07760
        • IES Maria Angels Cardona
      • Esporles, Baleares, Spain, 07190
        • IES Josep Font i Trias
      • Ferreries, Baleares, Spain, 07200
        • IES Biel Martí
      • Palma, Baleares, Spain, 07610
        • IES La Ribera
      • Pollença, Baleares, Spain, 07460
        • IES Guillem Cifre de Colonya
      • Porreras, Baleares, Spain, 07260
        • IES Porreres
      • Sa Pobla, Baleares, Spain, 07420
        • IES Can Peu Blanc
      • Santa Margarita, Baleares, Spain, 07450
        • IES Santa Margalida
      • Santanyi, Baleares, Spain, 07469
        • IES Santanyi
      • Sineu, Baleares, Spain, 07510
        • IES Sineu
      • Soller, Baleares, Spain, 07470
        • IES Guillem Colom Casasnoves
      • Son Servera, Baleares, Spain, 07550
        • IES Puig de Sa Font
    • Balears
      • Mao, Balears, Spain, 07703
        • IES Pasqual Calbó i Caldes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: School-based intervention
Behavioral: School 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking prevalence of adolescents in each group
Time Frame: 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.
six years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació d'investigació Sanitària de les Illes Balears

Collaborators

Instituto de Salud Carlos III

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

May 18, 2012

First Submitted That Met QC Criteria

May 18, 2012

First Posted (Estimate)

May 21, 2012

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • FI-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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