Pennsylvania Adolescent Smoking Study (PASStudy)

Study Overview
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Brief Summary
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The Pennsylvania Adolescent Smoking Study (PASStudy) will evaluate the effectiveness of Motivational Interviewing (MI) compared to Structured Brief Advice (SBA) to reduce cigarette smoking among adolescents who smoke. MI is a brief 5 session client-centered psychotherapeutic style intended to increase the probability that a person will enter into, continue and adhere to a specific change strategy. This will be compared with SBA, which implements Best Practice Guidelines (i.e., 5 A's and 5 R's) and assists participants in accessing the best available resources for smoking cessation.

Detailed Description
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The PASStudy is a Randomized Controlled Trial in which adolescents who smoke cigarettes will be randomized to receive either Motivational Interviewing (MI) or Structured Brief Advice (SBA). MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change. Based on the principles of motivational psychology, client-centered therapy, and the Transtheoretical Model, MI represents a general and practical approach for changing behaviors by enhancing and facilitating an individual's own internally motivated change process. SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines. The counseling covers the 5As and 5Rs. The 5As are: Ask about smoking or tobacco use, Advise all smokers to stop smoking, Assess willingness to quit, Assist with cessation, and Arrange for follow-up). The 5 R's are used by clinicians to help motivate participants who are not yet ready to change to quit smoking; they are Relevance - emphasize the benefits of quitting, Risks - inform the participant of the risks of continuing in smoking, Rewards - emphasize the benefits of quitting, Road Blocks - identify barriers to cessation, and, finally, Repetition or repeating the other four R's at every encounter. Participants in both groups will receive 5 counseling sessions over 8 weeks with the respective intervention. Participants randomized to the MI condition will receive five 45-60 minute MI sessions over the course of 8 weeks; 3 sessions occur in the office and the last 2 can be either by telephone or in the office. Participants randomized to the SBA condition will receive five 15-30 minute didactic SBA sessions over the course of 8 weeks; 3 sessions occur in the office and the last 2 can be either by telephone or in the office. Research staff will offer participants in both groups smoking reduction and cessation materials including websites, printed materials, hotlines, referrals to smoking cessation counseling programs. Participants will complete follow-up assessments at 8, 12 and 24 weeks post baseline. Self-reported smoking cessation, recorded on timeline followback calendars, will be biochemically verified via saliva cotinine tests at follow-up assessment visits. Prior to enrolling participants for randomization, each MI counselor will be certified for competence by completing the full, manualized treatment with up to 10 pilot participants.

Official Title
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Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Motivational Interviewing (MI)
* Behavioral: Structured Brief Advice (SBA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 14 and < 19 years of age. Must have smoked at least one cigarette during the past 30 days. Must have smoked at least 100 cigarettes in their lifetime. Fluent in English Signed and dated IRB approved informed consent form (and assent form for subjects of appropriate age as required by each institution) Exclusion Criteria: Severe or profound mental retardation Currently incarcerated or in a court mandated facility.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Motivational Interviewing (MI) | Behavioral: Motivational Interviewing (MI)<br>* MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.<br>|
| Active Comparator: 2<br>Structured Brief Advice (SBA) | Behavioral: Structured Brief Advice (SBA)<br>* SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. |  | Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any reports of smoking cessation will be verified by a saliva cotinine assay. |  | Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Motivational Interviewing, Structured Brief Advice, Adolescent Smoking, Behavioral Intervention, Smoking, Primary Care, Tobacco