Tobacco Use DisorderPhase 2NCT00670995
Tobacco Zero: Interactive Tobacco Education for Teens
A Phase 2 study testing Interactive Tobacco Education in people with Tobacco Use Disorder, run by Deschutes Research, Inc. at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 11 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Interactive Tobacco Education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,864 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Nov 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- Students unable to understand English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tobacco World: Interactive Tobacco Education for Teens
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.
Read the 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.
- Conditions
- Tobacco Use Disorder
- Being tested
- Interactive Tobacco Education
- 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.
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive Tobacco EducationBehavioural
Increase perceived behavioral control (self-efficacy) Decrease willingness to use tobacco Decrease intentions to use tobacco
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase perceived behavioral control (self-efficacy)
Measured: pre and post
Secondary outcomes (2)
Decrease willingness to use tobacco
Measured: pre and post
Decrease intentions to use tobacco
Measured: pre and post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2008 (estimated)
- Study startNov 2009
- Primary completionSep 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,864 participants (actual)
Sponsor and investigators
- Lead sponsor
- Deschutes Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Sponsor
- Investigators
- Herbert H Severson, PhD, Principal investigator, Deschutes Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00670995
- Sponsor's protocol ID
- 103623B
- Status last verified
- Feb 2012
- First submitted
- 29 Apr 2008
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco World: Interactive Tobacco Education for Teens
- ClinicalTrials.gov ID
- NCT00670995
- Acronym / sponsor ID
- 103623B
- Conditions
- 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.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,864 participants (actual)
- Lead sponsor
- Deschutes Research, Inc.University, hospital or other
- Collaborators
- Columbia University
- Study start
- Nov 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 2 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 11 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Students unable to understand English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Tobacco EducationIncrease perceived behavioral control (self-efficacy) Decrease willingness to use tobacco Decrease intentions to use tobacco | Behavioural | – |
Primary outcome
Increase perceived behavioral control (self-efficacy)
Time frame: pre and post
2 secondary outcomes
Decrease willingness to use tobacco
Time frame: pre and post
Decrease intentions to use tobacco
Time frame: pre and post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert H Severson, PhD principal investigator
Deschutes Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Interactive Tobacco Education in people with Tobacco Use Disorder, run by Deschutes Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase perceived behavioral control (self-efficacy) (time frame: pre and post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.