- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00650585
An Effectiveness Trial of Project ALERT
June 5, 2013 updated by: Pacific Institute for Research and Evaluation
Promising Programs for Substance Abuse Prevention: Replication and Evaluation Initiative
The purpose of this study is to replicate a longitudinal evaluation of Project ALERT, a substance abuse prevention program that targets middle school students.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
8338
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Pacific Institute for Research & Evaluation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Did not receive Project ALERT
|
|
Experimental: Treatment group
Received 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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported 30-day Use of Alcohol
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Self-reported 30-day Use of Cigarettes
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Self-reported 30-day Marijuana Use
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Self-reported 30-day Inhalant Use
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Self-reported Lifetime Alcohol Use
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Self-reported Lifetime Cigarette Use
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Self-reported Lifetime Marijuana Use
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Self-reported Lifetime Inhalant Use
Time Frame: measured approximately 30 days after intervention completed
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chris L Ringwalt, DrPH, Pacific Institute for Research & Evaluation
- Study Director: Heddy K Clark, Ph.D., Pacific Institute for Research & Evaluation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2004
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
March 31, 2008
First Submitted That Met QC Criteria
April 1, 2008
First Posted (Estimate)
April 2, 2008
Study Record Updates
Last Update Posted (Estimate)
June 13, 2013
Last Update Submitted That Met QC Criteria
June 5, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2003-DR-FX-001
- 2007-JF-FX-0064 (Other Grant/Funding Number: Dept. of Justice, OJJDP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Smoking
-
University of Southern CaliforniaAmerican Cancer Society, Inc.CompletedSmoking | Smoking Cessation | Smoking, Cigarette | Smoking Behaviors | Cessation, SmokingUnited States
-
University of VirginiaRecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking, Cigarette | Quitting SmokingUnited States
-
Columbia UniversityNational Cancer Institute (NCI)RecruitingSmoking | Smoking Cessation | Smoking Reduction | Smoking BehaviorsUnited States
-
National Cancer Institute (NCI)CompletedSmoking | Smoking Cessation | Cigarette Smoking | Tobacco, SmokingUnited States
-
Maastricht University Medical CenterThe Investigative Desk; SEO Amsterdam Economics; IVO Research InstituteEnrolling by invitationSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsNetherlands
-
Jennifer Marler, MDCompletedSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking BehaviorsUnited States
-
University GhentRecruitingSmoking | Smoking Tobacco | Smoking Prevention | Smoking CigaretteBelgium
-
Medical University of South CarolinaCompletedSmoking | Smoking Cessation | Smoking, Tobacco | Smoking, CigaretteUnited States
-
Medical University of South CarolinaRecruitingSmoking | Smoking Cessation | Tobacco Smoking | Cigarette SmokingUnited States
-
Ghana Health ServicesKwame Nkrumah University of Science and TechnologyNot yet recruitingSmoking Cessation | Smoking Reduction | Smoking, Tobacco | Smoking Behaviors
Clinical Trials on Project ALERT
-
RANDUniversity of Southern CaliforniaRecruiting
-
Brigham and Women's HospitalSanofiCompletedDeep Vein Thrombosis | Venous Thromboembolism | Pulmonary Embolism | Prevention | ProphylaxisUnited States
-
Columbia UniversityEnrolling by invitationSepsis | Electronic Health Records | Clinical Decision Support SystemsUnited States
-
University of California, San FranciscoCompleted
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Recruiting
-
Columbia UniversityEnrolling by invitationSepsis | Electronic Health Records | Clinical Decision Support SystemsUnited States
-
Imperial College LondonCompletedType1diabetesUnited Kingdom
-
Guangdong Provincial People's HospitalUnknownAcute Kidney Injury
-
Dana-Farber Cancer InstituteCompletedBreast Cancer | Gastrointestinal Cancer | Oral Cancer Directed Therapy | Oral ChemotherapyUnited States
-
Stanford UniversityCompleted