- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00115869
Hutchinson Smoking Prevention Project (HSPP)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98109-1024
- Fred Hutchinson Cancer Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No-intervention control
|
|
Experimental: Social influences school-based smoking prevention curriculum
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grades 3-10, school-based social influences tobacco use prevention curriculum
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Smoking Daily at 12th Grade
Time Frame: 12th grade
|
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?"
|
12th grade
|
Whether or Not Smoking Daily at 2 Years After High School
Time Frame: 2 years after high school
|
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?"
|
2 years after high school
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Arthur V. Peterson, Jr., PhD, Fred Hutchinson Cancer Center
Publications and helpful links
General Publications
- Peterson AV, Mann SL, Kealey KA, Marek PM. Experimental design and methods for school-based randomized trials. Experience from the Hutchinson Smoking Prevention Project (HSPP). Control Clin Trials. 2000 Apr;21(2):144-65. doi: 10.1016/s0197-2456(99)00050-1.
- Kealey KA, Peterson AV Jr, Gaul MA, Dinh KT. Teacher training as a behavior change process: principles and results from a longitudinal study. Health Educ Behav. 2000 Feb;27(1):64-81. doi: 10.1177/109019810002700107.
- Burt RD, Dinh KT, Peterson AV Jr, Sarason IG. Predicting adolescent smoking: a prospective study of personality variables. Prev Med. 2000 Feb;30(2):115-25. doi: 10.1006/pmed.1999.0605.
- Mann SL, Peterson AV Jr, Marek PM, Kealey KA. The Hutchinson Smoking Prevention Project trial: design and baseline characteristics. Prev Med. 2000 Jun;30(6):485-95. doi: 10.1006/pmed.2000.0664.
- Burt RD, Peterson AV Jr. Smoking cessation among high school seniors. Prev Med. 1998 May-Jun;27(3):319-27. doi: 10.1006/pmed.1998.0269.
- Peterson AV Jr, Kealey KA, Mann SL, Marek PM, Sarason IG. Hutchinson Smoking Prevention Project: long-term randomized trial in school-based tobacco use prevention--results on smoking. J Natl Cancer Inst. 2000 Dec 20;92(24):1979-91. doi: 10.1093/jnci/92.24.1979.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- FHCRC IRB #324
- R01CA038269 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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