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CompletedNCT00115882Updated May 24, 2016

Hutchinson Study of High School Smoking

A Phase 3 interventional study of MI + CBST in Smoking Cessation, sponsored by Fred Hutchinson Cancer Center. Completed at 1 site in United States. Open to participants aged 16 Years to 20 Years. Per ClinicalTrials.gov, last updated 2016-05-24.

Sponsored by Fred Hutchinson Cancer Center · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
2,151
Allocation
Randomized
Ages
16 Years to 20 Years
Sex
All
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Study summary

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.

Read the 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.

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Conditions studied

  • Smoking Cessation

Keywords

  • Adolescent
  • smoking
  • smoking cessation
  • counseling
03

In context

Lead sponsor

Fred Hutchinson Cancer Center is the lead sponsor of 537 studies on the registry; 79 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 45 (79%) have results posted.

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

04

Who can participate

Ages eligible
16 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
2,151 participants (actual)

Study arms

  • Experimental
    1

    proactive smoking-cessation telephone counseling

    Behavioral: MI + CBST

  • No intervention
    2

    no-intervention control

Interventions

  • BehavioralMI + 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.

    Also known as: HS Study Intervention

06

What researchers measure

Primary outcomes

  1. 6-months prolonged smoking abstinence at age 19 and at age 25

    Time frame: 6 months

Secondary outcomes

  1. smoking abstinence

    Time frame: 3-months, 1-month, and 7-day

  2. number of quit attempts in past 12 months

    Time frame: 12 months

  3. longest length of time without smoking in past 12 months

    Time frame: 12 months

  4. reduction in frequency/level of smoking

    Time frame: current; last 30 days

  5. change in readiness to quit

    Time frame: current

  6. change in stage of change

  7. composite of quit duration and number of cigarettes per day

    Time frame: past 12 months

07

Study locations

1 site
  • Fred Hutchinson Cancer Research Center
    Seattle, Washington 98109-1024, United States
08

References and documents

Publications

  • Kealey KA, Ludman EJ, Mann SL, Marek PM, Phares MM, Riggs KR, Peterson AV Jr. Overcoming barriers to recruitment and retention in adolescent smoking cessation. Nicotine Tob Res. 2007 Feb;9(2):257-70. doi: 10.1080/14622200601080315. PubMed 17365757 ↗
  • Liu J, Peterson AV Jr, Kealey KA, Mann SL, Bricker JB, Marek PM. Addressing challenges in adolescent smoking cessation: design and baseline characteristics of the HS Group-Randomized trial. Prev Med. 2007 Aug-Sep;45(2-3):215-25. doi: 10.1016/j.ypmed.2007.05.018. Epub 2007 Jun 4. PubMed 17628650 ↗
  • Kealey KA, Ludman EJ, Marek PM, Mann SL, Bricker JB, Peterson AV. Design and implementation of an effective telephone counseling intervention for adolescent smoking cessation. J Natl Cancer Inst. 2009 Oct 21;101(20):1393-405. doi: 10.1093/jnci/djp318. Epub 2009 Oct 12. PubMed 19822837 ↗
  • Peterson AV Jr, Kealey KA, Mann SL, Marek PM, Ludman EJ, Liu J, Bricker JB. Group-randomized trial of a proactive, personalized telephone counseling intervention for adolescent smoking cessation. J Natl Cancer Inst. 2009 Oct 21;101(20):1378-92. doi: 10.1093/jnci/djp317. Epub 2009 Oct 12. PubMed 19822836 ↗
  • Peterson AV Jr, Marek PM, Kealey KA, Bricker JB, Ludman EJ, Heffner JL. Does Effectiveness of Adolescent Smoking-Cessation Intervention Endure Into Young Adulthood? 7-Year Follow-Up Results from a Group-Randomized Trial. PLoS One. 2016 Feb 1;11(2):e0146459. doi: 10.1371/journal.pone.0146459. eCollection 2016. PubMed 26829013 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00115882
Lead sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Jun 27, 2005
Start date
Sep 2000
Primary completion
May 2014
Completion
Nov 2015
Last update
May 24, 2016

Study contacts

Arthur V. Peterson, Jr., PhD
principal investigator · Fred Hutchinson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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