Hutchinson Smoking Prevention Project (HSPP)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00115869
First received: June 26, 2005
Last updated: October 31, 2012
Last verified: October 2012
  Purpose

The Hutchinson Smoking Prevention Project is a 16-year, group-randomized trial to determine the extent to which a school-based (grades 3-10), theory-based, social-influences tobacco use prevention intervention can deter youth tobacco use throughout and beyond high school.


Condition Intervention Phase
Smoking Among Youth
Behavioral: Social-influences
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: Hutchinson Smoking Prevention Project

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of Participants Smoking Daily at 12th Grade [ Time Frame: 12th grade ] [ Designated as safety issue: No ]
    Response "1 to 3 cigarettes per day," "4 to 10 cigarettes per day," "11 to 20 cigarettes per day," or "More than 20 cigarettes per day" to the Item "How often do you currently smoke cigarettes?"

  • Whether or Not Smoking Daily at 2 Years After High School [ Time Frame: 2 years after high school ] [ Designated as safety issue: No ]
    Response (from the 2-years-after-high school questionnaire) "Daily: 1 to 10 cigarettes a day," "Daily: 11 to 20 cigarettes a day," "Daily: more than a pack a day" to the Item "How often do you currently smoke cigarettes?"


Enrollment: 8388
Study Start Date: September 1984
Study Completion Date: August 1999
Primary Completion Date: August 1999 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No-intervention control
Experimental: Social influences school-based smoking prevention curriculum Behavioral: Social-influences
grades 3-10, school-based social influences tobacco use prevention curriculum

Detailed Description:

Cigarette smoking remains the number one cause of preventable premature death in the U.S., annually killing more than 400,000 Americans. Without reversal of adolescent smoking trends, five million of today's youth will die prematurely of smoking-related illnesses. The 16-year Hutchinson Smoking Prevention Project (HSPP) was conducted in 1984-1999 to (1) address challenges of trial design and execution in school-based smoking prevention by developing the most rigorous school-based randomized trial possible, and (2) use the trial to answer the scientific questions, "To what extent can a theory-based, social-influences smoking prevention intervention spanning elementary, middle and high school grades reduce smoking among youth at 12th grade and two years post-high-school?"

The HSPP trial used a group-randomized, matched pair design with the school district as the experimental unit. Of 40 participating school districts, 20 were randomly assigned to the experimental (intervention) condition and 20 were assigned to the control (no HSPP intervention) condition. No restrictions were placed on the health promotion or tobacco use prevention activities of the control districts, thus enabling schools to continue whatever health curricula were normally offered. Main endpoints were daily smoking at 12th grade and 2 years after high school (Plus-2). Study participants (N=8,388) were two consecutive third grade enrollments in each of the 40 school districts. All third graders were followed to endpoint, including those who dropped out of school or otherwise left their school districts. The study achieved a 94% follow-up rate at the Plus-2 endpoint.

The HSPP intervention was a teacher-led, grades 3-10 tobacco use prevention curriculum plus unit-specific teacher training. There were 65 classroom lessons in the HSPP curriculum: 9 lessons in each of grades 3-5, 10 lessons in each of grades 6-7, 8 lessons in grade 8, and 5 lessons in each of grades 9-10, for a total number of 46.75 hours of classroom instruction time in grades 3-10. The HSPP uses an enhanced social influences approach that includes the 15 NCI-endorsed "essential elements" for school-based tobacco prevention and meets the CDC's "best practices" guidelines. The intervention's behavioral components featured skills for identifying and resisting social influences to smoke, correcting erroneous normative perceptions regarding smoking, promoting tobacco-free norms, and building self-efficacy for tobacco-free lifestyle choices. The intervention was developed to be practical for the school setting, emphasizing ease of use by teachers, good fit into school routines and with schools' existing educational objectives, and incorporation of topics/activities that are interesting, engaging and developmentally-appropriate for students.

  Eligibility

Ages Eligible for Study:   7 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All students enrolled in third grade in one of two consecutive classes of third graders in an HSPP participating Washington school district (1984-85; 1985-86; 1986-87).

Exclusion Criteria:

  • Enrolled but classified by participating school district as developmentally unable to learn.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00115869

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: Arthur V. Peterson, Jr., PhD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00115869     History of Changes
Other Study ID Numbers: FHCRC IRB #324, R01-CA38269
Study First Received: June 26, 2005
Results First Received: April 30, 2012
Last Updated: October 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Fred Hutchinson Cancer Research Center:
smoking prevention
tobacco use prevention
adolescent tobacco use
prevention intervention

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on July 22, 2014