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

Fundació d'investigació Sanitària de les Illes Balears

Status: Completed

Conditions: Smoking

Treatments: Behavioral: School intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01602796

FI-01

Details and patient eligibility

About

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) .

Enrollment: 2,226 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• None

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,226 participants in 2 patient groups

School-based intervention

Experimental group

Treatment:

Behavioral: School intervention

Control

No Intervention group