Tobacco Zero: Interactive Tobacco Education for Teens
Primary Purpose
Tobacco Use Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Interactive Tobacco Education
Sponsored by
About this trial
This is an interventional prevention trial for Tobacco Use Disorder focused on measuring Tobacco use among middle and junior high school students remains a concern among health educators., The use of tobacco prevention programs and their integration into school-based curricula has been lacking due to a number of factors.
Eligibility Criteria
Inclusion Criteria:
- Middle school students in 6th or 7th or 8th grade in Oregon and New York City whose parents have consented to have their child participate;
- Middle school health education teachers in Oregon and New York City
Exclusion Criteria:
- Students unable to understand English.
Sites / Locations
- Deschutes Research Inc
Outcomes
Primary Outcome Measures
Increase perceived behavioral control (self-efficacy)
Secondary Outcome Measures
Decrease willingness to use tobacco
Decrease intentions to use tobacco
Full Information
NCT ID
NCT00670995
First Posted
April 29, 2008
Last Updated
February 16, 2012
Sponsor
Deschutes Research, Inc.
Collaborators
Columbia University
1. Study Identification
Unique Protocol Identification Number
NCT00670995
Brief Title
Tobacco Zero: Interactive Tobacco Education for Teens
Official Title
Tobacco World: Interactive Tobacco Education for Teens
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deschutes Research, Inc.
Collaborators
Columbia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There have been a number of tobacco prevention programs developed and tested in the past few years, and some of the comprehensive programs have been promoted by the Office on Smoking and Health at the Centers for Disease Control (CDC). However, the use of these programs and integration into school-based curriculum has been lacking due to a number of factors. We are proposing to develop an interactive computer-based program for tobacco prevention aimed at middle school students. The CD-ROM is designed to be an adjunct to the existing health education curriculum provided for 6th through 8th grade students.
Detailed Description
The CD-ROM is based upon our Phase I prototype program entitled Tobacco World in which students are presented with a video arcade interface that offers them random access to several game-like activities in which they learn about tobacco and the negative health effects associated with tobacco use. We will expand the menu of options to include more complex activities and entertaining games.
The Phase II program will deliver engaging media to educate students about the risks of tobacco and peer and industry influences on their decisions regarding tobacco. Games and activities will be designed to act on mechanisms shown to be effective in decreasing intentions to use tobacco through changing attitudes, social images, beliefs about short and long term physical consequences, perceptions of peers' social images, subjective norms, and perceived behavioral control. We will test individual components of the program with middle school students for effectiveness in changing mediating variables related to initiation and use of tobacco.
The final program will be evaluated in a randomized trial where middle schools in Oregon and New York will be assigned to either an established tobacco prevention curriculum, or to the usual tobacco curriculum plus the Tobacco World program. Students will be assessed at pre-, post- and 6-month follow-up to evaluate the impact of program use on intentions, and actual tobacco use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Tobacco use among middle and junior high school students remains a concern among health educators., The use of tobacco prevention programs and their integration into school-based curricula has been lacking due to a number of factors.
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1864 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Interactive Tobacco Education
Intervention Description
Increase perceived behavioral control (self-efficacy) Decrease willingness to use tobacco Decrease intentions to use tobacco
Primary Outcome Measure Information:
Title
Increase perceived behavioral control (self-efficacy)
Time Frame
pre and post
Secondary Outcome Measure Information:
Title
Decrease willingness to use tobacco
Time Frame
pre and post
Title
Decrease intentions to use tobacco
Time Frame
pre and post
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Middle school students in 6th or 7th or 8th grade in Oregon and New York City whose parents have consented to have their child participate;
Middle school health education teachers in Oregon and New York City
Exclusion Criteria:
Students unable to understand English.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herbert H Severson, PhD
Organizational Affiliation
Deschutes Research, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deschutes Research Inc
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Tobacco Zero: Interactive Tobacco Education for Teens
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