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A Cluster Randomized Trial

Christopher L. Ringwalt, DrPH; Heddy Kovach Clark, PhD; Sean Hanley, MPH; Stephen R. Shamblen, PhD; Robert L. Flewelling, PhD

Arch Pediatr Adolesc Med. 2009;163(7):625-632.

Objective  To evaluate the effects of Project ALERT on adolescents' lifetime and 30-day use of cigarettes, alcohol, marijuana, and inhalants.

Design  Cluster randomized trial.

Setting  Schools from 11 states were enrolled in 2 successive cohorts from 2004 to 2008.

Participants  All public schools in the United States that included grades 6 through 8 and enrolled at least 100 students in sixth grade were recruited. Of the 40 schools that began the study, 34 (17 per condition) completed it. Data were analyzed from 5883 unique participants.

Intervention  Project ALERT, a manualized classroom-based substance use prevention curriculum for the middle grades, was taught to sixth and seventh graders.

Main Outcome Measures  Students were surveyed before the onset of the intervention, as sixth graders, and after the completion of the 2-year intervention, as seventh graders. Outcome measures included lifetime and 30-day use of cigarettes, alcohol, marijuana, and inhalants.

Results  At baseline, students in the intervention condition were slightly to moderately more likely to report use for each of the 8 measures examined than were students in the control condition. For all measures except lifetime use of cigarettes, these differences were less pronounced at follow-up and therefore were in the direction of favorable program effects. These changes were statistically significant, however, for only 1 outcome measure, past 30-day use of alcohol (reduction in the adjusted odds ratio from 2.07 at baseline to 1.32 at follow-up; P = .006).

Conclusion  Project ALERT was not effective when delivered to the sixth grade population we targeted.

Trial Registration  clinicaltrials.gov Identifier: NCT00650585

Author Affiliations: Pacific Institute for Research and Evaluation, Chapel Hill, North Carolina (Drs Ringwalt, Clark, and Flewelling and Mr Hanley), and Louisville, Kentucky (Dr Shamblen).

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