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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Fundació d'investigació Sanitària de les Illes Balears
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier:
NCT01602796
First received: May 18, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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 Intervention
Smoking
Behavioral: School intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Fundació d'investigació Sanitària de les Illes Balears:

Primary Outcome Measures:
  • Smoking prevalence of adolescents in each group [ Time Frame: six years ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 2226
Study Start Date: September 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   11 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602796

Contacts
Contact: Aina M Yañez, phD 656612192 aina.yanez@caubet-cimera.es

Locations
Spain
IES Josep Miquel Guardia Recruiting
Alaior, Baleares, Spain, 07340
IES Alcudia Recruiting
Alcudia, Baleares, Spain, 07410
IES Baltasar Porcel Recruiting
Andraxt, Baleares, Spain, 07150
IES Llorenç Garcias i Font Recruiting
Artà, Baleares, Spain, 07057
IES Son Ferrer Recruiting
Calvia, Baleares, Spain, 07181
IES Capdepera Recruiting
Capdepera, Baleares, Spain, 07580
IES Maria Angels Cardona Recruiting
Ciudadela, Baleares, Spain, 07760
IES Josep Font i Trias Recruiting
Esporlas, Baleares, Spain, 07190
IES Biel Martí Recruiting
Ferreries, Baleares, Spain, 07200
IES La Ribera Recruiting
Palma, Baleares, Spain, 07610
IES Porreres Recruiting
Porreras, Baleares, Spain, 07260
IES Can Peu Blanc Recruiting
Sa Pobla, Baleares, Spain, 07420
IES Santa Margalida Recruiting
Santa Margarita, Baleares, Spain, 07450
IES Santanyi Recruiting
Santanyi, Baleares, Spain, 07469
IES Sineu Recruiting
Sineu, Baleares, Spain, 07510
IES Guillem Colom Casasnoves Recruiting
Soller, Baleares, Spain, 07470
IES Puig de Sa Font Recruiting
Son Servera, Baleares, Spain, 07550
IES Albuhaira Recruiting
Muro, Baleare, Spain, 07440
IES Pasqual Calbó i Caldes Recruiting
Mao, Balears, Spain, 07703
IES Guillem Cifre de Colonya Recruiting
Baleares, Spain, 07460
Sponsors and Collaborators
Fundació d'investigació Sanitària de les Illes Balears
Instituto de Salud Carlos III
  More Information

No publications provided by Fundació d'investigació Sanitària de les Illes Balears

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Fundació d'investigació Sanitària de les Illes Balears
ClinicalTrials.gov Identifier: NCT01602796     History of Changes
Other Study ID Numbers: FI-01
Study First Received: May 18, 2012
Last Updated: May 18, 2012
Health Authority: Spain: Ministry of Health

ClinicalTrials.gov processed this record on August 27, 2014