Enhanced Smoking Cessation for University Students

Study Overview
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Brief Summary
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This trial studies how well a new smoking cessation and prevention intervention works in enhancing smoking cessation for university students. The new intervention may be easier to use for students to quit smoke.

Detailed Description
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PRIMARY OBJECTIVES: I. To establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression. II. Demonstrate the feasibility of a smoking prevention website. OUTLINE: Participants are assigned to 1 of 2 arms. ARM I: Participants who currently smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. Participants also complete 3 internet surveys over 20 minutes. ARM II: Participants who currently do not smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. After completion of study, participants are followed up at 3 months.

Official Title
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Enhanced Smoking Cessation for University Students

Conditions
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Cigarette Smoker, Current Every Day Smoker

Intervention / Treatment
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* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CESSATION ARM: Student at University of Houston Central Campus or Texas A&M University CESSATION ARM: Smoke 1 or more cigarettes a day CESSATION ARM: Speak and read English CESSATION ARM: Signed informed consent and an acknowledgement of participation requirements CESSATION ARM: Be enrolled in at least one class at respective campus at baseline CESSATION ARM: Provide current contact information CESSATION ARM: Have access to the Internet PREVENTION ARM: Student at University of Houston Central Campus or Texas A&M University PREVENTION ARM: Speak and read English PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline PREVENTION ARM: Provide current contact information PREVENTION ARM: Have access to the Internet PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale) CESSATION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study PREVENTION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study Exclusion Criteria: CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9]) CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT [Alcohol Use Disorders Identification Test] measure) PREVENTION ARM: Current tobacco use PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9]) PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure) CESSATION ARM: Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (smoker, survey)<br>Participants who currently smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. Participants also complete 3 internet surveys over 20 minutes. | Other: Survey Administration<br>* Complete surveys<br>|
| Experimental: Arm II (non-smoker, survey)<br>Participants who currently do not smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. | Other: Survey Administration<br>* Complete surveys<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ease of use and appeal of various features of the program |  | Up to 5 months | 
| The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention |  | Up to 5 months | 
| Behavior modification determined by EVOLVE Follow up Survey-Smoker |  | Up to 5 months | 
| Knowledge of modules in the program |  | Up to 5 months | 
| Feasibility defined as 90% of the student participants indicating that the intervention program is easy to use and can fit into their schedule | Associations between the dependent variables and smoking status will be evaluated with linear and logistic regression models with campus of origin and smoking status as independent predictors of these outcomes. | Up to 5 months |