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CompletedNCT00135265Updated Jun 28, 2010

PROS Smokebusters: Adolescent Smoking Cessation in Pediatric Primary Care

A Phase 1 interventional study of smoking cessation, practice change in Health Care Quality, Access, and Evaluation and Smoking Cessation, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-06-28.

Sponsored by University of Rochester · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
4,100
Allocation
Randomized
Ages
14 Years and older
Sex
All
01

Study summary

This is a pilot study addressing office systems and clinician behavior change surrounding smoking cessation interventions for teens. The investigators' long-term goal is to improve the quality of clinical preventive services in practice-based research network settings. Their specific aims are to:

  • a) pilot procedures for recruitment and randomization of PROS practices; and b) field trial/pilot PROS practitioner cessation counseling and practices' enrollment of adolescent patients; and
  • assess the feasibility of pediatric clinician referral of adolescent patients to internet-based adjuncts for smoking cessation.

The investigators will evaluate a pilot round of recruitment and randomization, and smoking cessation training and delivery in 10 PROS practice sites; and assess the acceptability of study procedures and on-line internet counseling adjunct referral feasibility within PROS practice sites. Up to 1000 adolescents presenting for well visits will complete a short baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6 weeks to provide preliminary estimates of cessation counseling effectiveness for future studies. The investigators will field test measures, describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and behaviors for 100 smokers.

**we have completed recruitment of providers; we are recruiting teens ONLY at this point**

Read the detailed description

This is a pilot study addressing office systems and clinician behavior change surrounding smoking cessation interventions for teens. The investigators' long-term goal is to improve the quality of clinical preventive services in practice-based research network settings. Their specific aims are to:

  • a) pilot procedures for recruitment and randomization of PROS practices; and b) field trial/pilot PROS practitioner cessation counseling and practices' enrollment of adolescent patients; and
  • assess the feasibility of pediatric clinician referral of adolescent patients to internet-based adjuncts for smoking cessation.

The investigators will evaluate a pilot round of recruitment and randomization, and smoking cessation training and delivery in 10 PROS practice sites; and assess the acceptability of study procedures and on-line internet counseling adjunct referral feasibility within PROS practice sites. Up to 1000 adolescents presenting for well visits will complete a short baseline survey prior to their well-visit. A sample of them will be surveyed by phone at 4-6 weeks to provide preliminary estimates of cessation counseling for future studies. The investigators will field test measures, describe the patterns of smoking among youth, and explore how much receiving interventions affects motivation, quitting, abstinence/relapse attitudes, attitudes towards internet-based outreach strategies, and behaviors for 100 smokers.

02

Conditions studied

  • Health Care Quality, Access, and Evaluation
  • Smoking Cessation

Keywords

  • smoking cessation
  • adolescents
03

In context

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Practitioner recruitment criteria:

  • Has a patient flow of several adolescents per week.
  • Reads and speaks English.
  • Able and willing to provide informed consent

Patient recruitment criteria:

  • 14 years or older
  • Lives in a home or apartment with access to a phone or mail address
  • Speaks English
  • Cognitively able to respond to survey questions
  • Cognitively able to give assent and obtain parent/guardian permission or consent

Exclusion criteria

Exclusion Criteria:

  • Providers: already participating in a PROS study
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
Double (Care provider, Investigator)
Enrollment
4,100 participants (estimated)

Interventions

  • Behavioralsmoking cessation, practice change

    Providers will be trained in a brief smoking cessation intervention for teens.

06

What researchers measure

Primary outcomes

  1. smoking cessation rates

    Time frame: 4-6 weeks

  2. quit attempts

    Time frame: 4-6 weeks

  3. provider practice change

    Time frame: 6 months

07

Study locations

1 site
  • University of Rochester
    Rochester, New York 14642, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00135265
Lead sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
First posted
Aug 25, 2005
Start date
Oct 2006
Primary completion
Oct 2009
Completion
Jan 2010
Last update
Jun 28, 2010

Study contacts

Jonathan D Klein, MD, MPH
principal investigator · University of Rochester
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.

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