- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00670995
Tobacco Zero: Interactive Tobacco Education for Teens
Tobacco World: Interactive Tobacco Education for Teens
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97401
- Deschutes Research Inc
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Increase perceived behavioral control (self-efficacy)
Time Frame: pre and post
|
pre and post
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Decrease willingness to use tobacco
Time Frame: pre and post
|
pre and post
|
|
Decrease intentions to use tobacco
Time Frame: pre and post
|
pre and post
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Herbert H Severson, PhD, Deschutes Research, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 103623B
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