Pennsylvania Adolescent Smoking Study (PASStudy)

• ClinicalTrials.gov Identifier: NCT00381329
• Recruitment Status: Unknown
• First Posted: September 27, 2006
• Last Update Posted: January 30, 2009
• Sponsor: Pennsylvania Department of Health
• Collaborators: Children's Hospital of Philadelphia; University of Pittsburgh; Lehigh Valley Hospital
• Information provided by: Pennsylvania Department of Health

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: Motivational Interviewing (MI); Behavioral: Structured Brief Advice (SBA)	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 330 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. Any reports of smoking cessation will be verified by a saliva cotinine assay. [ Time Frame: Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24 ]

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 18 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. ≥ 14 and < 19 years of age.
2. Must have smoked at least one cigarette during the past 30 days.
3. Must have smoked at least 100 cigarettes in their lifetime.
4. Fluent in English
5. Signed and dated IRB approved informed consent form (and assent form for subjects of appropriate age as required by each institution)

Exclusion Criteria:

1. Severe or profound mental retardation
2. Currently incarcerated or in a court mandated facility.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Pennsylvania Department of Health

Children's Hospital of Philadelphia

University of Pittsburgh

Lehigh Valley Hospital

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kalkhuis-Beam S, Stevens SL, Baumritter A, Carlson EC, Pletcher JR, Rodriguez D, Audrain-McGovern J. Participant- and study-related characteristics predicting treatment completion and study retention in an adolescent smoking cessation trial. J Adolesc Health. 2011 Oct;49(4):371-8. doi: 10.1016/j.jadohealth.2011.01.012. Epub 2011 May 24.

• ClinicalTrials.gov Identifier: NCT00381329
• Other Study ID Numbers: SAP#4100027295_2
• First Posted: September 27, 2006
• Last Update Posted: January 30, 2009
• Last Verified: January 2009

Keywords provided by Pennsylvania Department of Health:

Motivational Interviewing; Structured Brief Advice; Adolescent Smoking; Behavioral Intervention; Smoking; Primary Care; Tobacco