Experimental design and methods for school-based randomized trials. Experience from the Hutchinson Smoking Prevention Project (HSPP).

Nonadherence to accepted design principles for randomized trials has been a limitation of school-based intervention research. Designed to overcome these limitations, the Hutchinson Smoking Prevention Project (HSPP) is a 15-year randomized trial to determine the extent to which a school-based (grades 3-12) tobacco use prevention intervention can deter youth tobacco use throughout and beyond high school. This paper presents the HSPP experimental design, together with methods for its implementation, and an evaluation of the degree to which HSPP has adhered to principles of randomized trials. Results from the experimental design and its conduct include (1) a recruitment rate of 97.6% (40 of 41 targeted school districts), (2) full and active participation for the trial's duration by 100% of the 40 school districts recruited, (3) implementation by virtually all teachers (99%+), with 86% implementation fidelity, and (4) outcome determination for 94.3% (7910) of 8388 original study participants identified 12 years previously at baseline. The high degree of rigor achieved by the HSPP experimental design ensures confidence in the trial's soon-to-be available intervention effectiveness results. Equally important, for future school-based trials, the HSPP design and its execution have illustrated that school-based research can adhere to the principles of rigorous randomized trials, with high rates of implementation, and very high rates of recruitment, maintenance, and follow-up of study participants, even for studies with decade-long follow-up periods. Rigor in school-based trials can be achieved through a combination of (1) commitment to the principles of randomized trials, (2) attention to the special challenges of trials specific to the school setting, (3) adoption and meticulous execution of proven methods for trial conduct, and (4) establishment at the outset of principles for maintaining positive collaborative relationships with participating school districts for the duration of the trial. These findings are important in light of the great potential for using the nation's schools to access youth for health promotion/risk-factor prevention.