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Hutchinson Smoking Prevention Project (HSPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00115869
Recruitment Status : Completed
First Posted : June 27, 2005
Results First Posted : November 29, 2012
Last Update Posted : November 29, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Smoking Among Youth
Intervention Behavioral: Social-influences
Enrollment 8388
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.
Arm/Group Title No-intervention Control Grade 3-12 School-based Intervention
Hide Arm/Group Description No-intervention control group Grade 3-12 school-influences school-based smoking prevention intervention
Period Title: Overall Study
Started 4211 4177
Completed Data Collection at 12th Grade 3876 3847
Completed 3894 3881 [1]
Not Completed 317 296
[1]
Follow-up at two years post high school.
Arm/Group Title No-intervention Control Social Influences School-based Smoking Prevention Curriculum Total
Hide Arm/Group Description No-intervention control group Social influences school-based smoking prevention curriculum group Total of all reporting groups
Overall Number of Baseline Participants 4211 4177 8388
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4211 participants 4177 participants 8388 participants
<=18 years
4211
 100.0%
4177
 100.0%
8388
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4211 participants 4177 participants 8388 participants
Female
2058
  48.9%
2073
  49.6%
4131
  49.2%
Male
2153
  51.1%
2104
  50.4%
4257
  50.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4211 participants 4177 participants 8388 participants
4211 4177 8388
1.Primary Outcome
Title Number of Participants Smoking Daily at 12th Grade
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No-intervention Control Social Influences School-based Smoking Prevention Curriculum
Hide Arm/Group Description:
No-intervention control condition
School-based social-influences smoking prevention curriculum condition
Overall Number of Participants Analyzed 3876 3847
Measure Type: Number
Unit of Measure: participants
995 976
2.Primary Outcome
Title Whether or Not Smoking Daily at 2 Years After High School
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title No-intervention Control School-based Smoking Prevention Curriculum
Hide Arm/Group Description:
No-intervention control group
Social influences school-based smoking prevention curriculum group
Overall Number of Participants Analyzed 3894 3881
Measure Type: Number
Unit of Measure: participants
1132 1103
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title No-intervention Control Group School-based Smoking Prevention Curriculum Group
Hide Arm/Group Description no-intervention control school-based smoking prevention curriculum
All-Cause Mortality
No-intervention Control Group School-based Smoking Prevention Curriculum Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
No-intervention Control Group School-based Smoking Prevention Curriculum Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4211 (0.00%)   0/4177 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
No-intervention Control Group School-based Smoking Prevention Curriculum Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4211 (0.00%)   0/4177 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arthur V. Peterson, Jr. PhD
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-5131
EMail: avpeters@fhcrc.org
Layout table for additonal information
Responsible Party: Arthur V. Peterson, Jr., PhD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00115869    
Other Study ID Numbers: FHCRC IRB #324
R01CA038269 ( U.S. NIH Grant/Contract )
First Submitted: June 26, 2005
First Posted: June 27, 2005
Results First Submitted: April 30, 2012
Results First Posted: November 29, 2012
Last Update Posted: November 29, 2012