Pennsylvania Adolescent Smoking Study (PASStudy)

NCT ID: NCT00381329

Last Updated: 2009-01-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-05-31

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.

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.

Conditions

Smoking Cessation

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

Motivational Interviewing (MI)

Group Type: ACTIVE_COMPARATOR

Motivational Interviewing (MI)

Intervention Type: BEHAVIORAL

MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.

2

Structured Brief Advice (SBA)

Group Type: ACTIVE_COMPARATOR

Structured Brief Advice (SBA)

Intervention Type: BEHAVIORAL

SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.

Interventions

Motivational Interviewing (MI)

MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.

Intervention Type: BEHAVIORAL

Structured Brief Advice (SBA)

SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Lehigh Valley Hospital

OTHER

Sponsor Role: collaborator

Pennsylvania Department of Health

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Janet Audrain-McGovern, Ph.D

Role: STUDY_CHAIR

University of Pennsylvania

Deborah Moss, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Sarah Stevens, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Jon Pletcher, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Pamela Murray, MD, MHP

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Sara B Kinsman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

The Children's Hospital of Philadelphia/University of Pennsylvania

Locations

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 21939867 (View on PubMed)

Other Identifiers

SAP#4100027295_2

Identifier Type: -

Identifier Source: org_study_id