Hutchinson Study of High School Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00115882
First received: June 26, 2005
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The primary goal of the Hutchinson Study of High School Smoking, a group-randomized trial conducted by the Fred Hutchinson Cancer Research Center in partnership with 50 Washington State high schools, is to develop and evaluate an innovative proactive smoking cessation intervention, based upon Motivational Interviewing (MI) and Cognitive Behavioral Skills Training (CBST), for its effectiveness in reaching teen smokers and helping them succeed in quitting smoking. A positive finding would have significant implications for reducing youth smoking and, ultimately, improving the nation's health.


Condition Intervention Phase
Smoking Cessation
Behavioral: MI + CBST
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Proactive Smoking Cessation for Adolescents

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 6-months prolonged smoking abstinence at age 19 and at age 25 [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • smoking abstinence [ Time Frame: 3-months, 1-month, and 7-day ] [ Designated as safety issue: No ]
  • number of quit attempts in past 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • longest length of time without smoking in past 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • reduction in frequency/level of smoking [ Time Frame: current; last 30 days ] [ Designated as safety issue: No ]
  • change in readiness to quit [ Time Frame: current ] [ Designated as safety issue: No ]
  • change in stage of change [ Designated as safety issue: No ]
  • composite of quit duration and number of cigarettes per day [ Time Frame: past 12 months ] [ Designated as safety issue: No ]

Enrollment: 2151
Study Start Date: September 2000
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
proactive smoking-cessation telephone counseling
Behavioral: MI + CBST
The HS Study intervention consisted of proactive identification and recruitment of eligible smokers (and selected nonsmokers) within the target population, and a protocol-guided series of counselor-initiated, personally-tailored telephone calls (from 1 to 10, depending on participant's interest) to eligible high school senior smokers and nonsmokers in experimental high schools. The telephone-delivered behavioral intervention integrated Motivational Interviewing and Cognitive Behavioral Skills building. Content and dose were tailored to the individual.
Other Name: HS Study Intervention
No Intervention: 2
no-intervention control

Detailed Description:

Rates of smoking prevalence among US adolescents remain unacceptably high, with 24% of high school seniors smoking monthly and 16% smoking daily. Unfortunately, without intervention, for the majority of these adolescent smokers, smoking will be a long-term addiction. Recent studies have demonstrated that a majority of teen smokers want to quit and try to do so, but with little success.

The Hutchinson Study of High School Smoking is a 2-arm group-randomized trial in adolescent smoking cessation, conducted by the Fred Hutchinson Cancer Research Center in partnership with 50 Washington State high schools. Twenty-five high schools are randomly assigned to the experimental (intervention) condition and 25 are assigned to the control (no intervention) condition. The trial uses innovative and rigorous trial design and methodology to address recruitment, retention, and other methodological challenges encountered in early adolescent cessation trials, to provide a rigorous test of in innovative proactive smoking cessation intervention. Participants are 2,151 high school students (all smokers and a sample of nonsmokers identified via baseline survey of all enrolled students at the end of their junior year).

The intervention, delivered during the senior year of high school, consists of a series of counselor-initiated, individually-tailored telephone counseling calls. Incorporating both Motivational Interviewing and Cognitive Behavioral skills training, the counseling telephone calls aim to increase smokers' motivation for quitting smoking, build skills for smoking cessation, and assist with relapse prevention. For nonsmokers, the telephone calls provide positive reinforcement of students' abstinence choices and help build skills for supporting peers' efforts to quit smoking. Complementary intervention components include an interactive cessation/informational Web site (www.Matchbreaker.org) and school-based promotional materials (cessation posters, school newspaper ads).

Participants are followed to two follow-up times: the first at age 19 (approximately 6 months post-high school), and the second at age 25, to assess immediately after high school, and again in young adulthood, the intervention's impact on cessation status, number of quit attempts, change in readiness to quit and reduction in frequency and level of smoking.

Concerning effectiveness in reaching teen smokers, 65.3% (691 out of 1058) smokers in the intervention condition were successfully recruited, and participated in the telephone counseling.

Concerning effectiveness in helping teen smokers quit smoking, at the first follow-up, the intervention increased the percentage who achieved 6-month prolonged smoking abstinence among all smokers (21.8% in the experimental condition vs 17.7% in the control condition, difference = 4.0%, 95% confidence interval [CI] = −0.2 to 8.1, P = .06) and in particular among daily smokers (10.1% vs 5.9%, difference = 4.1%, 95% CI = 0.8 to 7.1, P = .02). There was also generally strong evidence of intervention impact for 3-month, 1-month, and 7-day abstinence and duration since last cigarette (P = .09, .015, .01, and .03, respectively). The intervention effect was strongest among male daily smokers and among female less-than-daily smokers.

  Eligibility

Ages Eligible for Study:   16 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All high school juniors enrolled in a participating high school who reported on their baseline survey that they smoked once a month or more; and a selected sample of nonsmoker respondents (former smokers and never smokers with close friends who smoke)
  • Written or verbal parental consent required for intervention participation by students under age 18

Exclusion Criteria:

  • Enrolled in participating school at time of baseline survey, but not developmentally able to independently complete the baseline survey
  • Not able to understand or speak English sufficiently to complete informed consent for telephone counseling
  • Foreign exchange students
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115882

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Arthur V. Peterson, Jr., PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
Publications:
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00115882     History of Changes
Other Study ID Numbers: FHCRC IRB #4727, R01-CA82569
Study First Received: June 26, 2005
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
Adolescent
smoking
smoking cessation
counseling

Additional relevant MeSH terms:
Smoking
Food Habits
Habits

ClinicalTrials.gov processed this record on July 31, 2014