Intranet-based Tobacco Prevention Program for Children

Tobacco Smoking Clinical Trial

— Intranet  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00680875
• Other study ID #: CA98555
• Status: Completed
• Phase: N/A
• First received: May 16, 2008
• Last updated: October 13, 2011
• Start date: March 2007
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The purpose of this research is to create an effective, disseminable, and exciting computer-based tobacco prevention program for 5th and 6th grade students. The goal of this school-based program is to decrease children's behavioral intentions and willingness to use tobacco, and to prevent or delay their initiation of tobacco use.

We will augment the 5th grade program with a booster program in 6th grade, and evaluate the long-term efficacy of the entire tobacco prevention program by conducting a randomized controlled trial in elementary and middle schools.

Description:

The aims of this randomized trail are as follows:

• Conduct a randomized trial to assess the effectiveness of the Tobacco Free Town (TFT) program at preventing or delaying initiation of tobacco by 7th grade, and decreasing behavioral intentions and willingness to use tobacco, as compared to the usual tobacco-prevention curriculum implemented in schools. The TFT program consists of 17 effective components delivered in eight sessions over a four-week period in 5th grade with two booster sessions delivered within a one-week period in 6th grade.

• Develop and test the effectiveness of 7 components to include in the booster sessions in 6th grade using an iterative development process including qualitative evaluation using focus and user groups, and culminating in a quantitative evaluation assessing the effectiveness of individual program components.

• Develop a program guide for teachers to accompany the program and develop parent newsletters for teachers to send home with students after each session.

• Examine change from 5th to 7th grade in the mechanisms that the TFT program is designed to target, and assess if these cognitive mechanisms serve to mediate the effects of the program on smoking outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3225
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 14 Years

Eligibility

Inclusion Criteria:

• 5th and 6th grade students attending participating public schools in six counties within a one hour drive of Eugene

Exclusion Criteria:

• Children must be able to read and understand English.

Study Design

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

Related Conditions & MeSH terms

• Health Promotion
• Tobacco Smoking

Intervention

Behavioral:
• Click City
School-based intranet delivery of tobacco use prevention program for 5th and 6th graders using interactive and engaging game-like multi-media technology.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self reported cigarette and smokeless tobacco use		2 years	No
Secondary	Intention and willingness to smoke cigarettes or chew smokeless tobacco in the future.		2 years	No