Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT00115869
Status:
COMPLETED
Last Update Posted:
2012-11-29
First Post:
2005-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Hutchinson Smoking Prevention Project
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
Hutchinson Smoking Prevention Project
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HSPP
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01CA038269 | NIH | None | https://reporter.nih.gov/quic… | View |