Clinical trial NCT00650585: An Effectiveness Trial of Project ALERT
Official title: Promising Programs for Substance Abuse Prevention: Replication and Evaluation Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Drinking
Smoking
Marijuana Smoking
Keywords: smoking
alcohol
prevention
prevention & control
Lead sponsor: Pacific Institute for Research and Evaluation
Sponsor class: OTHER
First posted: 2008-04-02
Enrollment: 8338
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to replicate a longitudinal evaluation of Project ALERT, a substance abuse prevention program that targets middle school students.

Detailed description: Project ALERT is a substance abuse prevention program that targets middle school students. The purposes of this evaluation are to test its immediate and one-year effectiveness in a randomized experimental design that will span a total of 2.5 years for each of two cohorts. The cohorts are spaced one year apart to reduce our implementation and data collection burdens at any one time. The design for the two cohorts is identical. In schools randomly assigned to the treatment group, instructors receive Project ALERT training and materials prior to beginning the program and have access to technical assistance on request. In schools randomly assigned to the control group, teachers implement whatever substance abuse prevention curricula they normally would (if any).

Eligibility criteria: Inclusion Criteria:

* schools with 6th-8th grades housed together on a common campus
* schools with 6th grade student population of at least 100 students
* schools with no current 6th, 7th, or 8th grade implementation of any drug prevention curriculum recognized as a model program by a federally-sponsored registry
* all regular education students in the targeted grade must participate

Exclusion Criteria:

* students in self-contained classrooms (i.e., special education classes)

Primary outcomes:
measure: Self-reported 30-day Use of Alcohol
timeFrame: measured approximately 30 days after intervention completed
measure: Self-reported 30-day Use of Cigarettes
timeFrame: measured approximately 30 days after intervention completed
measure: Self-reported 30-day Marijuana Use
timeFrame: measured approximately 30 days after intervention completed
measure: Self-reported 30-day Inhalant Use
timeFrame: measured approximately 30 days after intervention completed
measure: Self-reported Lifetime Alcohol Use
timeFrame: measured approximately 30 days after intervention completed
measure: Self-reported Lifetime Cigarette Use
timeFrame: measured approximately 30 days after intervention completed
measure: Self-reported Lifetime Marijuana Use
timeFrame: measured approximately 30 days after intervention completed
measure: Self-reported Lifetime Inhalant Use
timeFrame: measured approximately 30 days after intervention completed
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Pacific Institute for Research & Evaluation
state: North Carolina
Study officials:
affiliation: Pacific Institute for Research & Evaluation
name: Chris L Ringwalt, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Institute for Research & Evaluation
name: Heddy K Clark, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Ringwalt CL, Clark HK, Hanley S, Shamblen SR, Flewelling RL. Project ALERT: a cluster randomized trial. Arch Pediatr Adolesc Med. 2009 Jul;163(7):625-32. doi: 10.1001/archpediatrics.2009.88.