Pennsylvania Adolescent Smoking Study (PASStudy)
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|ClinicalTrials.gov Identifier: NCT00381329|
Recruitment Status : Unknown
Verified January 2009 by Pennsylvania Department of Health.
Recruitment status was: Active, not recruiting
First Posted : September 27, 2006
Last Update Posted : January 30, 2009
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Motivational Interviewing (MI) Behavioral: Structured Brief Advice (SBA)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking|
|Study Start Date :||September 2007|
|Estimated Study Completion Date :||May 2010|
Active Comparator: 1
Motivational Interviewing (MI)
Behavioral: Motivational Interviewing (MI)
MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.
Active Comparator: 2
Structured Brief Advice (SBA)
Behavioral: Structured Brief Advice (SBA)
SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.
- Reduction in number of cigarettes smoked as measured by the Timeline Follow-back. [ Time Frame: Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24 ]
- Any reports of smoking cessation will be verified by a saliva cotinine assay. [ Time Frame: Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00381329
|United States, Pennsylvania|
|Lehigh Valley Hospital|
|Allentown, Pennsylvania, United States, 18104|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Children's Hospital of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15213|
|Study Chair:||Janet Audrain-McGovern, Ph.D||University of Pennsylvania|
|Principal Investigator:||Deborah Moss, MD, MPH||University of Pittsburgh|
|Principal Investigator:||Sarah Stevens, MD, MPH||Lehigh Valley Hospital|
|Principal Investigator:||Jon Pletcher, MD||University of Pittsburgh|
|Principal Investigator:||Pamela Murray, MD, MHP||University of Pittsburgh|
|Principal Investigator:||Sara B Kinsman, MD, PhD||The Children's Hospital of Philadelphia/University of Pennsylvania|