Intranet-based Tobacco Prevention Program for Children (Intranet)
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|ClinicalTrials.gov Identifier: NCT00680875|
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : October 14, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Health Promotion Tobacco Smoking||Behavioral: Click City||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
5th and 6th grade students who attend schools randomly assigned to the intervention condition.
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.
Other Name: Tobacco Free Town
No Intervention: Usual Curriculum
5th and 6th grade students attending schools randomly assigned to the usual curriculum control condition.
- Self reported cigarette and smokeless tobacco use [ Time Frame: 2 years ]
- Intention and willingness to smoke cigarettes or chew smokeless tobacco in the future. [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680875
|United States, Oregon|
|Oregon Research Institute|
|Eugene, Oregon, United States, 97403|
|Principal Investigator:||Judy A Andrews, Ph.D.||Oregon Research Institute|