An Effectiveness Trial of Project ALERT
Primary Purpose
Alcohol Drinking, Smoking, Marijuana Smoking
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project ALERT
Sponsored by
About this trial
This is an interventional prevention trial for Alcohol Drinking focused on measuring smoking, alcohol, prevention, prevention & control
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)
Sites / Locations
- Pacific Institute for Research & Evaluation
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Treatment group
Arm Description
Did not receive Project ALERT
Received Project ALERT
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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).
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).
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT00650585
First Posted
March 31, 2008
Last Updated
June 5, 2013
Sponsor
Pacific Institute for Research and Evaluation
1. Study Identification
Unique Protocol Identification Number
NCT00650585
Brief Title
An Effectiveness Trial of Project ALERT
Official Title
Promising Programs for Substance Abuse Prevention: Replication and Evaluation Initiative
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pacific Institute for Research and Evaluation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking, Smoking, Marijuana Smoking
Keywords
smoking, alcohol, prevention, prevention & control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8338 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Did not receive Project ALERT
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
Received Project ALERT
Intervention Type
Behavioral
Intervention Name(s)
Project ALERT
Other Intervention Name(s)
Adolescent Learning Experiences in Resistance Training
Intervention Description
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/.
Primary Outcome Measure Information:
Title
Self-reported 30-day Use of Alcohol
Description
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.
Time Frame
measured approximately 30 days after intervention completed
Title
Self-reported 30-day Use of Cigarettes
Description
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.
Time Frame
measured approximately 30 days after intervention completed
Title
Self-reported 30-day Marijuana Use
Description
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.
Time Frame
measured approximately 30 days after intervention completed
Title
Self-reported 30-day Inhalant Use
Description
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.
Time Frame
measured approximately 30 days after intervention completed
Title
Self-reported Lifetime Alcohol Use
Description
Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).
Time Frame
measured approximately 30 days after intervention completed
Title
Self-reported Lifetime Cigarette Use
Description
Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).
Time Frame
measured approximately 30 days after intervention completed
Title
Self-reported Lifetime Marijuana Use
Description
Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).
Time Frame
measured approximately 30 days after intervention completed
Title
Self-reported Lifetime Inhalant Use
Description
Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).
Time Frame
measured approximately 30 days after intervention completed
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris L Ringwalt, DrPH
Organizational Affiliation
Pacific Institute for Research & Evaluation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heddy K Clark, Ph.D.
Organizational Affiliation
Pacific Institute for Research & Evaluation
Official's Role
Study Director
Facility Information:
Facility Name
Pacific Institute for Research & Evaluation
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19581545
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.
Results Reference
result
Links:
URL
http://www.projectalert.com/
Description
Project ALERT website
Learn more about this trial
An Effectiveness Trial of Project ALERT
We'll reach out to this number within 24 hrs