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Effectiveness of Intervention on Reducing the Prevalence of Smoking Among Adolescents

NCT01602796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2226

Last updated 2021-03-10

No results posted yet for this study

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) .

Conditions

  • Smoking

Interventions

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.

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fundació d'investigació Sanitària de les Illes Balears

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
11 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2019-09-30
Completion
2020-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01602796 on ClinicalTrials.gov