Clinical trial NCT01306552: Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools
Official title: BEST Prevention Study. "Berlin Evaluates School Tabacco Prevention" Study Evaluation of a Combined Parent-student Programme for Smoking Prevention in Berlin Schools
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Tobacco use
Adolescents
Primary prevention
Program effectiveness
Parental component
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Senatsverwaltung für Bildung, Wissenschaft und Forschung, Berlin, Germany
name: KARUNA prevents, Berlin, Germany
First posted: 2011-03-02
Enrollment: 3400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of regular smokers among students at the 2 year follow-up assessment.
timeFrame: 2 years
Secondary outcomes:
measure: Students' attitudes towards smoking and smoking-related self-efficacy
timeFrame: 2 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics
Study officials:
affiliation: Charité University Medical Center, Institute for Social Medicine, Epidemiology and Health Economics
name: Stefan N Willich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krist L, Lotz F, Burger C, Strobele-Benschop N, Roll S, Rieckmann N, Muller-Nordhorn J, Willich SN, Muller-Riemenschneider F. Long-term effectiveness of a combined student-parent and a student-only smoking prevention intervention among 7th grade school children in Berlin, Germany. Addiction. 2016 Dec;111(12):2219-2229. doi: 10.1111/add.13537. Epub 2016 Sep 19.
citation: Muller-Riemenschneider F, Krist L, Burger C, Strobele-Benschop N, Roll S, Rieckmann N, Muller-Nordhorn J, Willich SN. Berlin evaluates school tobacco prevention - BEST prevention: study design and methodology. BMC Public Health. 2014 Aug 23;14:871. doi: 10.1186/1471-2458-14-871.