Hutchinson Study of High School Smoking

Smoking Cessation Clinical Trial

Official title:

Proactive Smoking Cessation for Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00115882
• Other study ID #: FHCRC IRB #4727
• Secondary ID: R01CA082569
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2005
• Last updated: May 20, 2016
• Start date: September 2000
• Est. completion date: November 2015

Study information

• Verified date: May 2016
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2151
• Est. completion date: November 2015
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 20 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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.

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. Epu — View Citation

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. Epub 2007 Jun 4. — View Citation

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: 10.10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-months prolonged smoking abstinence at age 19 and at age 25		6 months	No
Secondary	smoking abstinence		3-months, 1-month, and 7-day	No
Secondary	number of quit attempts in past 12 months		12 months	No
Secondary	longest length of time without smoking in past 12 months		12 months	No
Secondary	reduction in frequency/level of smoking		current; last 30 days	No
Secondary	change in readiness to quit		current	No
Secondary	change in stage of change			No
Secondary	composite of quit duration and number of cigarettes per day		past 12 months	No

External Links

•   Fred Hutchinson Cancer Research Center