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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680875
Other study ID # CA98555
Secondary ID
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


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
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