Tobacco Zero: Interactive Tobacco Education for Teens

Tobacco Use Disorder Clinical Trial

Official title:

Tobacco World: Interactive Tobacco Education for Teens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670995
• Other study ID #: 103623B
• Status: Completed
• Phase: Phase 2
• First received: April 29, 2008
• Last updated: February 16, 2012
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2012
• Source: Deschutes Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1864
• Est. completion date: November 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 11 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Interactive Tobacco Education
Increase perceived behavioral control (self-efficacy) Decrease willingness to use tobacco Decrease intentions to use tobacco

Locations

Country	Name	City	State
United States	Deschutes Research Inc	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Deschutes Research, Inc.	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase perceived behavioral control (self-efficacy)		pre and post	No
Secondary	Decrease willingness to use tobacco		pre and post	No
Secondary	Decrease intentions to use tobacco		pre and post	No

External Links

•   Sponsor's Web site