An Effectiveness Trial of Project ALERT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier:
NCT00650585
First received: March 31, 2008
Last updated: June 5, 2013
Last verified: June 2013
  Purpose

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


Condition Intervention
Alcohol Drinking
Smoking
Marijuana Smoking
Behavioral: Project ALERT

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Promising Programs for Substance Abuse Prevention: Replication and Evaluation Initiative

Resource links provided by NLM:


Further study details as provided by Pacific Institute for Research and Evaluation:

Primary Outcome Measures:
  • Self-reported 30-day Use of Alcohol [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    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.

  • Self-reported 30-day Use of Cigarettes [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    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.

  • Self-reported 30-day Marijuana Use [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    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.

  • Self-reported 30-day Inhalant Use [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    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.

  • Self-reported Lifetime Alcohol Use [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).

  • Self-reported Lifetime Cigarette Use [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).

  • Self-reported Lifetime Marijuana Use [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).

  • Self-reported Lifetime Inhalant Use [ Time Frame: measured approximately 30 days after intervention completed ] [ Designated as safety issue: No ]
    Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).


Enrollment: 8338
Study Start Date: May 2004
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Did not receive Project ALERT
Experimental: Treatment group
Received Project ALERT
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/.
Other Name: Adolescent Learning Experiences in Resistance Training

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00650585

Locations
United States, North Carolina
Pacific Institute for Research & Evaluation
Chapel Hill, North Carolina, United States, 27514
Sponsors and Collaborators
Pacific Institute for Research and Evaluation
Investigators
Principal Investigator: Chris L Ringwalt, DrPH Pacific Institute for Research & Evaluation
Study Director: Heddy K Clark, Ph.D. Pacific Institute for Research & Evaluation
  More Information

Additional Information:
Publications:
Responsible Party: Pacific Institute for Research and Evaluation
ClinicalTrials.gov Identifier: NCT00650585     History of Changes
Other Study ID Numbers: 2003-DR-FX-001, 2007-JF-FX-0064
Study First Received: March 31, 2008
Results First Received: July 27, 2009
Last Updated: June 5, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pacific Institute for Research and Evaluation:
smoking
alcohol
prevention
prevention & control

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior

ClinicalTrials.gov processed this record on October 19, 2014