An Effectiveness Trial of Project ALERT

Smoking Clinical Trial

Official title:

Promising Programs for Substance Abuse Prevention: Replication and Evaluation Initiative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00650585
• Other study ID #: 2003-DR-FX-001
• Secondary ID: 2007-JF-FX-0064
• Status: Completed
• Phase: N/A
• First received: March 31, 2008
• Last updated: June 5, 2013
• Start date: May 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2013
• Source: Pacific Institute for Research and Evaluation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8338
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Drinking
• Marijuana Smoking
• Smoking

Intervention

Behavioral:
• Project ALERT
Project ALERT (Adolescent Learning Experiences in Resistance Training) is a drug prevention curriculum designed for middle-school students (11 to 14 years old). The 11 lessons in the first year and 3 booster lessons in the second year focus on alcohol, tobacco, marijuana, and inhalants - the substances that adolescents are most likely to use. Project ALERT uses participatory activities and videos to help motivate youth to avoid drug use, to teach youth skills and strategies to resist peer pressures to use drugs, and to establish social norms against drug-use. More information about Project ALERT may be found at http://www.projectalert.best.org/.

Locations

Country	Name	City	State
United States	Pacific Institute for Research & Evaluation	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pacific Institute for Research and Evaluation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported 30-day Use of Alcohol	Students completed an 81-item self-report questionnaire. They were asked on how many days they had used alcohol in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.	measured approximately 30 days after intervention completed	No
Primary	Self-reported 30-day Use of Cigarettes	Students completed an 81-item self-report questionnaire. They were asked on how many days they had smoked cigarettes in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.	measured approximately 30 days after intervention completed	No
Primary	Self-reported 30-day Marijuana Use	Students completed an 81-item self-report questionnaire. They were asked on how many days they had used marijuana in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.	measured approximately 30 days after intervention completed	No
Primary	Self-reported 30-day Inhalant Use	Students completed an 81-item self-report questionnaire. They were asked on how many days they had used inhalants in the previous 30 days. Response options included "none," "1 or 2 days in the last month," "3 to 5 days in the last month," "6 to 19 days in the last month," and "20 or more days in the last month." Response options were dichotomized into none and at least one day.	measured approximately 30 days after intervention completed	No
Primary	Self-reported Lifetime Alcohol Use	Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).	measured approximately 30 days after intervention completed	No
Primary	Self-reported Lifetime Cigarette Use	Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).	measured approximately 30 days after intervention completed	No
Primary	Self-reported Lifetime Marijuana Use	Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).	measured approximately 30 days after intervention completed	No
Primary	Self-reported Lifetime Inhalant Use	Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).	measured approximately 30 days after intervention completed	No

External Links

•   Project ALERT website