- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00381329
Pennsylvania Adolescent Smoking Study (PASStudy)
Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Allentown, Pennsylvania, United States, 18104
- Lehigh Valley Hospital
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Philadelphia, Pennsylvania, United States, 19104
- The Children's Hospital of Philadelphia
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Pittsburgh, Pennsylvania, United States, 15213
- Children's Hospital of Pittsburgh
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 1
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)
|
SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Any reports of smoking cessation will be verified by a saliva cotinine assay.
Time Frame: Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24
|
Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24
|
Collaborators and Investigators
Investigators
- 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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SAP#4100027295_2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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