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Hutchinson Smoking Prevention Project

Hutchinson Smoking Prevention Project

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00115869
Acronym
HSPP
Enrollment
8388
Registered
2005-06-27
Start date
1984-09-30
Completion date
1999-08-31
Last updated
2012-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Among Youth

Keywords

smoking prevention, tobacco use prevention, adolescent tobacco use, prevention intervention

Brief summary

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.

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.

Interventions

BEHAVIORALSocial-influences

grades 3-10, school-based social influences tobacco use prevention curriculum

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fred Hutchinson Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Smoking Daily at 12th Grade12th gradeResponse 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 School2 years after high schoolResponse (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?

Countries

United States

Participant flow

Recruitment details

Study participants were recruited as 3rd graders in the consecutive years from 40 collaborating school districts in Washington State. The study participants were recruited in 3 waves: Wave I, 6 school districts (1984 and 1985); Wave II, 14 school districts (1985 and 1986); and Wave III, 20 school districts (1986 and 1987).

Pre-assignment details

Forty-two (42) children were not eligible for the study because they were considered by their schools to be developmentally unable to learn.

Participants by arm

ArmCount
No-intervention Control
No-intervention control group
4,211
Social Influences School-based Smoking Prevention Curriculum
Social influences school-based smoking prevention curriculum group
4,177
Total8,388

Baseline characteristics

CharacteristicNo-intervention ControlSocial Influences School-based Smoking Prevention CurriculumTotal
Age, Categorical
<=18 years
4211 Participants4177 Participants8388 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Region of Enrollment
United States
4211 participants4177 participants8388 participants
Sex: Female, Male
Female
2058 Participants2073 Participants4131 Participants
Sex: Female, Male
Male
2153 Participants2104 Participants4257 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 4,2110 / 4,177
serious
Total, serious adverse events
0 / 4,2110 / 4,177

Outcome results

Primary

Number of Participants Smoking Daily at 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?

Time frame: 12th grade

ArmMeasureValue (NUMBER)
No-intervention ControlNumber of Participants Smoking Daily at 12th Grade995 participants
Social Influences School-based Smoking Prevention CurriculumNumber of Participants Smoking Daily at 12th Grade976 participants
Primary

Whether or Not Smoking Daily at 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?

Time frame: 2 years after high school

ArmMeasureValue (NUMBER)
No-intervention ControlWhether or Not Smoking Daily at 2 Years After High School1132 participants
Social Influences School-based Smoking Prevention CurriculumWhether or Not Smoking Daily at 2 Years After High School1103 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026