Alcohol DrinkingNCT00650585
An Effectiveness Trial of Project ALERT
A study testing Project ALERT in people with Alcohol Drinking and Smoking, run by Pacific Institute for Research and Evaluation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alcohol Drinking, Smoking, Marijuana Smoking
- What is being tested?
- Project ALERT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,338 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- students in self-contained classrooms (i.e., special education classes)
Trial locations and contacts
1 site in 1 country.
United States1 site
Pacific Institute for Research & Evaluation
Chapel Hill, North Carolina, 27514
About this study
Official title: 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.
Read the 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).
- Conditions
- Alcohol Drinking, Smoking, Marijuana Smoking
- Being tested
- Project ALERT
- Keywords
- smoking, alcohol, prevention, prevention & control
- Medical subject headings
- Alcohol Drinking, Smoking, Marijuana Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ALERTBehavioural
Also called Adolescent Learning Experiences in Resistance Training
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/.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Did not receive Project ALERT |
| Treatment group | Experimental | Received Project ALERT Receives: Behavioral: Project ALERT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured approximately 30 days after intervention completed
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: measured approximately 30 days after intervention completed
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: measured approximately 30 days after intervention completed
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: measured approximately 30 days after intervention completed
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: measured approximately 30 days after intervention completed
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: measured approximately 30 days after intervention completed
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: measured approximately 30 days after intervention completed
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: measured approximately 30 days after intervention completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (estimated)
- Study startMay 2004
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 8,338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Institute for Research and Evaluation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris L Ringwalt, DrPH, Principal investigator, Pacific Institute for Research & EvaluationHeddy K Clark, Ph.D., Study director, Pacific Institute for Research & Evaluation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00650585
- Sponsor's protocol ID
- 2003-DR-FX-001
- Other IDs
- 2007-JF-FX-0064
- Status last verified
- Jun 2013
- First submitted
- 31 Mar 2008
- Last updated
- 13 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 19581545
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promising Programs for Substance Abuse Prevention: Replication and Evaluation Initiative
- ClinicalTrials.gov ID
- NCT00650585
- Acronym / sponsor ID
- 2003-DR-FX-001
- Conditions
- Alcohol Drinking, Smoking, Marijuana Smoking
- Keywords
- smoking, alcohol, prevention, prevention & control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,338 participants (actual)
- Lead sponsor
- Pacific Institute for Research and EvaluationUniversity, hospital or other
- Study start
- May 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 2 Apr 2008 (estimated)
- Results
- Posted 21 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Did not receive Project ALERT |
| Treatment group | Experimental | Behavioral: Project ALERTReceived Project ALERT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- students in self-contained classrooms (i.e., special education classes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project ALERTAlso: Adolescent Learning Experiences in Resistance TrainingProject 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/. | Behavioural | Treatment group |
Primary outcome
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.
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.
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.
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.
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).
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).
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).
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19581545Ringwalt 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.
- Project ALERT websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chris L Ringwalt, DrPH principal investigator
Pacific Institute for Research & Evaluation
Heddy K Clark, Ph.D. study director
Pacific Institute for Research & Evaluation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project ALERT in people with Alcohol Drinking and Smoking, run by Pacific Institute for Research and Evaluation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 30-day Use of Alcohol (time frame: measured approximately 30 days after intervention completed). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00650585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2013.