Pennsylvania Adolescent Smoking Study (PASStudy)

Smoking Cessation Clinical Trial

Official title:

Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00381329
• Other study ID #: SAP#4100027295_2
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 26, 2006
• Last updated: January 29, 2009
• Start date: September 2007
• Est. completion date: May 2010

Study information

• Verified date: January 2009
• Source: Pennsylvania Department of Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 330
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Motivational Interviewing (MI)
MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.
• Structured Brief Advice (SBA)
SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Pennsylvania Department of Health	Children's Hospital of Philadelphia, Children's Hospital of Pittsburgh, Lehigh Valley Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in number of cigarettes smoked as measured by the Timeline Follow-back.		Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24
Secondary	Any reports of smoking cessation will be verified by a saliva cotinine assay.		Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24