Intranet-based Tobacco Prevention Program for Children (Intranet)

October 13, 2011 updated by: Oregon Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

3225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Eugene, Oregon, United States, 97403
        • Oregon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Tobacco Free Town
No Intervention: Usual Curriculum
5th and 6th grade students attending schools randomly assigned to the usual curriculum control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Self reported cigarette and smokeless tobacco use
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Intention and willingness to smoke cigarettes or chew smokeless tobacco in the future.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Research Institute

Investigators

  • Principal Investigator: Judy A Andrews, Ph.D., Oregon Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 16, 2008

First Posted (Estimate)

May 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 14, 2011

Last Update Submitted That Met QC Criteria

October 13, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CA98555

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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