Intranet-based Tobacco Prevention Program for Children (Intranet)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00680875
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : October 14, 2011
Information provided by (Responsible Party):
Oregon Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Health Promotion Tobacco Smoking Behavioral: Click City Not Applicable

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : March 2007
Actual Primary Completion Date : May 2011
Actual Study Completion Date : May 2011

Arm Intervention/treatment
Experimental: Intervention
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.

Primary Outcome Measures :
  1. Self reported cigarette and smokeless tobacco use [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Intention and willingness to smoke cigarettes or chew smokeless tobacco in the future. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00680875

United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Principal Investigator: Judy A Andrews, Ph.D. Oregon Research Institute

Responsible Party: Oregon Research Institute Identifier: NCT00680875     History of Changes
Other Study ID Numbers: CA98555
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: October 14, 2011
Last Verified: October 2011

Keywords provided by Oregon Research Institute:
School Based Services