Experimental design and methods for school-based randomized trials. Experience from the Hutchinson Smoking Prevention
A V Peterson1, S L Mann, K A Kealey
1Cancer Prevention Research Program, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA.
Controlled Clinical Trials
|March 15, 2000
Summary
The Hutchinson Smoking Prevention Project (HSPP) demonstrates rigorous school-based randomized trial methods. This tobacco prevention study achieved high recruitment and participant retention, ensuring reliable intervention effectiveness results.
Area of Science:
- Public Health
- Clinical Trials
- Adolescent Health
Background:
- School-based intervention research often faces challenges adhering to randomized trial design principles.
- The Hutchinson Smoking Prevention Project (HSPP) was established to address these limitations in youth tobacco use prevention.
Purpose of the Study:
- To present the experimental design, implementation methods, and adherence to randomized trial principles of the HSPP.
- To evaluate the feasibility of conducting rigorous, long-term school-based health intervention research.
Main Methods:
- A 15-year randomized trial involving school-based tobacco use prevention intervention for students in grades 3-12.
- Detailed tracking of recruitment, participation, implementation fidelity, and long-term participant follow-up.
Main Results:
- Achieved a 97.6% recruitment rate across 40 school districts.
- Maintained 100% participation from recruited districts and 86% teacher implementation fidelity.
- Successfully determined outcomes for 94.3% of original participants after 12 years.
Conclusions:
- The HSPP demonstrates that school-based research can achieve high levels of rigor, including recruitment, maintenance, and follow-up, even over a decade.
- Commitment to trial principles, addressing school-specific challenges, meticulous execution, and strong collaborations are key to successful school-based randomized trials.
- Findings support the use of schools for large-scale youth health promotion and risk-factor prevention initiatives.
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