Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools

Tobacco Use Disorder Clinical Trial

— BEST  

Official title:

BEST Prevention Study. "Berlin Evaluates School Tabacco Prevention" Study Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01306552
• Other study ID #: EA1/133/10
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2011
• Last updated: March 1, 2011
• Start date: October 2010
• Est. completion date: August 2013

Study information

• Verified date: January 2011
• Source: Charite University, Berlin, Germany
• Contact: Falk Mueller-Riemenschneider, MD
• Phone: +4930450529036
• Email: Falk.Mueller-Riemenschneider[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the effectiveness of a combined parent-student program for smoking prevention in 7th graders in Berlin schools.

Description:

The hazardous health effects of smoking and second hand smoke are well known and published. Despite wide spread tobacco prevention campaigns and initiatives, the proportion of children and adolescents who smoke remains high, especially in Germany. Current research indicates that comprehensive strategies, especially with a parental involvement component, appear to be the most effective school-based smoking prevention programs.

A popular smoking prevention program in the city of Berlin is the Karuna interactive show jumping course "Still smoking or already alive?" ("Rauchst du noch oder lebst du schon?" Mitmach - Parcours). This parcours was designed to teach facts about smoking and its health-damaging effects, its negative effects on physical appearance, to promote communication and to enhance participants' awareness of social pressure and their self-efficacy to deal with these situations. No study to date has evaluated its effectiveness in reducing smoking rates among participating students. The study aim is to test the effectiveness of an interactive combined student-parent intervention in 7th graders regarding the reduction of smoking rates among secondary school children aged 12-15 compared to no smoking prevention intervention using self-reported questionnaires. In addition, it will be tested whether the program that involves the combination of a student and a parent intervention is more effective in the reduction of smoking rates in comparison to a program without a parental intervention.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3400
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

School Inclusion Criteria A school is eligible for the study if

• it is located in Berlin

• has 7th grade classes (students between 12-15 years)

School Exclusion Criteria:

• schools offers an extensive smoking prevention program for their students that includes parental involvement.

• schools that do not agree to stop visiting the KARUNA e.V. smoking parcours (if they do) for the next two years in case of being randomized to the control group.

• schools that do not agree to have a parents' night (separate or part of the typical parents' nights) where trained health coaches will introduce and discuss the topic of smoking prevention in youth in case of being randomized to the combined student-parent intervention.

Student Inclusion Criteria A student is eligible for the study if

• Female or male in the 7th grade

• Signed written assent

• Intellectual and physical ability of participant to make an informed decision about study participation

• Attends one of the participating schools

• Has signed approval from parent/caregiver

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Student-Intervention only group
One visit to the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?") during 7th grade. The parcours takes approximately 3 hours to complete. The parcours consists of 7 interactive stations where a class of students learns about differences between smokers and non-smokers in terms of health status such as atherosclerosis prevalence, loss of smell or lung capacity and aging. Students also learn about the toxic ingredients in cigarettes. Each station includes a quiz to complete by each group of students. At the end of the parcours, a moderator will announce which group of students accumulated the most points. For more information on the contents of the parcours see http://www.karuna-prevents.de/index.php.
• Multi-component Intervention
One visit to the smoking prevention parcours offered by KARUNA e.V. ("Rauchst Du noch oder lebst Du schon?") + one parent night with information about smoking prevention and one informational letter by mail
• Control Group
One visit to the Nutrition and Physical Activity Parcours offered by KARUNA e.V. ("Kinderleicht gesund zu leben"). (same set up as the smoking prevention parcours with topics around healthy nutrition and promotion of physical activity)

Locations

Country	Name	City	State
Germany	Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics	Berlin

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	KARUNA prevents, Berlin, Germany, Senatsverwaltung für Bildung, Wissenschaft und Forschung, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of regular smokers among students at the 2 year follow-up assessment.	The primary study outcome is the percentage of regular smokers among students at the 2 year follow-up assessment.	2 years	No
Secondary	Students' attitudes towards smoking and smoking-related self-efficacy	The secondary study outcomes are attitudes towards smoking and smoking-related self-efficacy.; In addition, we will assess the acceptability of the program components.; Other secondary outcomes include: Percentage of 7th graders that started smoking during the study period.; Percentage of 7th graders that stopped smoking during the study period.; Percentage of 7th graders that are smoking less at the 2 year assessment compared to baseline assessment.; Percentage of 7th graders that are smoking more at the 2 year assessment compared to baseline assessment.	2 years	No