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

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ClinicalTrials.gov Identifier: NCT01602796
Recruitment Status : Completed
First Posted : May 21, 2012
Last Update Posted : March 10, 2021
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundació d'investigació Sanitària de les Illes Balears

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) .


Condition or disease Intervention/treatment Phase
Smoking Behavioral: School intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2226 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial
Study Start Date : September 2011
Actual Primary Completion Date : September 2019
Actual Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking

Arm Intervention/treatment
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.

No Intervention: Control



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602796


Locations
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Sponsors and Collaborators
Fundació d'investigació Sanitària de les Illes Balears
Instituto de Salud Carlos III
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier: NCT01602796    
Other Study ID Numbers: FI-01
First Posted: May 21, 2012    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided