Smoking CessationPhase 2NCT00381329
Pennsylvania Adolescent Smoking Study (PASStudy)
A Phase 2 study testing Motivational Interviewing (MI) and Structured Brief Advice (SBA) in people with Smoking Cessation, run by Pennsylvania Department of Health at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Motivational Interviewing (MI) and Structured Brief Advice (SBA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2007to May 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- ≥ 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)
Who cannot join
- Severe or profound mental retardation
- Currently incarcerated or in a court mandated facility.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18104
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking
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.
Read the 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
- Being tested
- Motivational Interviewing (MI), Structured Brief Advice (SBA)
- Keywords
- Motivational Interviewing, Structured Brief Advice, Adolescent Smoking, Behavioral Intervention, Smoking, Primary Care, Tobacco
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change.
Structured Brief Advice (SBA)Behavioural
SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Motivational Interviewing (MI) Receives: Behavioral: Motivational Interviewing (MI) |
| 2 | Active comparator | Structured Brief Advice (SBA) Receives: Behavioral: Structured Brief Advice (SBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in number of cigarettes smoked as measured by the Timeline Follow-back.
Measured: Baseline, Pre Counseling Sessions 1-5, Weeks 8, 12, 24
Secondary outcomes (1)
Any reports of smoking cessation will be verified by a saliva cotinine assay.
Measured: Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2006 (estimated)
- Study startSep 2007
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pennsylvania Department of Health
- Sponsor type
- Other government
- Collaborators
- Children's Hospital of Philadelphia, University of Pittsburgh, Lehigh Valley Hospital
- Investigators
- Janet Audrain-McGovern, Ph.D, Study chair, University of PennsylvaniaDeborah Moss, MD, MPH, Principal investigator, University of PittsburghSarah Stevens, MD, MPH, Principal investigator, Lehigh Valley HospitalJon Pletcher, MD, Principal investigator, University of PittsburghPamela Murray, MD, MHP, Principal investigator, University of PittsburghSara B Kinsman, MD, PhD, Principal investigator, The Children's Hospital of Philadelphia/University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00381329
- Sponsor's protocol ID
- SAP#4100027295_2
- Status last verified
- Jan 2009
- First submitted
- 26 Sep 2006
- Last updated
- 30 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21939867
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pennsylvania Adolescent Smoking Study (PASS) - Randomized Controlled Trial Comparing Motivational Interviewing and Structured Brief Advice for the Reduction of Adolescent Cigarette Smoking
- ClinicalTrials.gov ID
- NCT00381329
- Acronym / sponsor ID
- SAP#4100027295_2
- Conditions
- Smoking Cessation
- Keywords
- Motivational Interviewing, Structured Brief Advice, Adolescent Smoking, Behavioral Intervention, Smoking, Primary Care, Tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Pennsylvania Department of HealthOther government
- Collaborators
- Children's Hospital of Philadelphia, University of Pittsburgh, Lehigh Valley Hospital
- Study start
- Sep 2007
- Study completion
- May 2010 (estimated)
- First posted
- 27 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Motivational Interviewing (MI)Motivational Interviewing (MI) |
| 2 | Active comparator | Behavioral: Structured Brief Advice (SBA)Structured Brief Advice (SBA) |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ≥ 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)
Key exclusion criteria (2 listed)
- Severe or profound mental retardation
- Currently incarcerated or in a court mandated facility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing (MI)MI is an empirically supported, client-centered, directive method for matching counseling to an individual's readiness to change. | Behavioural | 1 |
| Structured Brief Advice (SBA)SBA includes the administration of scripted, brief cessation counseling that follows standard health care smoking cessation guidelines. | Behavioural | 2 |
Primary outcome
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
1 secondary outcome
Any reports of smoking cessation will be verified by a saliva cotinine assay.
Time frame: Baseline, Counseling Sessions 1-5, Weeks 8, 12, 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
- Derived from this study: PubMed 21939867Kalkhuis-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet Audrain-McGovern, Ph.D study chair
University of Pennsylvania
Deborah Moss, MD, MPH principal investigator
University of Pittsburgh
Sarah Stevens, MD, MPH principal investigator
Lehigh Valley Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Motivational Interviewing (MI) and Structured Brief Advice (SBA) in people with Smoking Cessation, run by Pennsylvania Department of Health at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00381329, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.