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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8338

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Adolescent Learning Experiences in Resistance Training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pacific Institute for Research and Evaluation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2004

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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