NCT00115882

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,151

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2005

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

May 24, 2016

Status Verified

May 1, 2016

Enrollment Period

13.7 years

First QC Date

June 26, 2005

Last Update Submit

May 20, 2016

Conditions

Keywords

Adolescentsmokingsmoking cessationcounseling

Outcome Measures

Primary Outcomes (1)

  • 6-months prolonged smoking abstinence at age 19 and at age 25

    6 months

Secondary Outcomes (7)

  • smoking abstinence

    3-months, 1-month, and 7-day

  • number of quit attempts in past 12 months

    12 months

  • longest length of time without smoking in past 12 months

    12 months

  • reduction in frequency/level of smoking

    current; last 30 days

  • change in readiness to quit

    current

  • +2 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

proactive smoking-cessation telephone counseling

Behavioral: MI + CBST

2

NO INTERVENTION

no-intervention control

Interventions

MI + CBSTBEHAVIORAL

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
1

Eligibility Criteria

Age16 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Related Publications (5)

  • 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.

    PMID: 17365757BACKGROUND
  • 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.

    PMID: 17628650BACKGROUND
  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Arthur V. Peterson, Jr., PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2005

First Posted

June 27, 2005

Study Start

September 1, 2000

Primary Completion

May 1, 2014

Study Completion

November 1, 2015

Last Updated

May 24, 2016

Record last verified: 2016-05

Locations