Pennsylvania Adolescent Smoking Study (PASStudy)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Pennsylvania Department of Health.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh
Lehigh Valley Hospital
Information provided by:
Pennsylvania Department of Health
ClinicalTrials.gov Identifier:
NCT00381329
First received: September 26, 2006
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

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 Intervention Phase
Smoking Cessation
Behavioral: Motivational Interviewing (MI)
Behavioral: Structured Brief Advice (SBA)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Pennsylvania Department of Health:

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

Estimated Enrollment: 330
Study Start Date: September 2007
Estimated Study Completion Date: May 2010
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381329

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
Children's Hospital of Pittsburgh
Lehigh Valley Hospital
Investigators
Study Chair: Janet Audrain-McGovern, Ph.D University of Pennsylvania
Principal Investigator: Deborah Moss, MD, MPH Children's Hospital of Pittsburgh
Principal Investigator: Sarah Stevens, MD, MPH Lehigh Valley Hospital
Principal Investigator: Jon Pletcher, MD Children's Hospital of Pittsburgh
Principal Investigator: Pamela Murray, MD, MHP Children's Hospital of Pittsburgh
Principal Investigator: Sara B Kinsman, MD, PhD The Children's Hospital of Philadelphia/University of Pennsylvania
  More Information

No publications provided by Pennsylvania Department of Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00381329     History of Changes
Other Study ID Numbers: SAP#4100027295_2
Study First Received: September 26, 2006
Last Updated: January 29, 2009
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Pennsylvania Department of Health:
Motivational Interviewing
Structured Brief Advice
Adolescent Smoking
Behavioral Intervention
Smoking
Primary Care
Tobacco

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 17, 2014