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An Effectiveness Trial of Project ALERT

Promising Programs for Substance Abuse Prevention: Replication and Evaluation Initiative

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00650585
Enrollment
8338
Registered
2008-04-02
Start date
2004-05-31
Completion date
2008-06-30
Last updated
2013-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Marijuana Smoking, Smoking

Keywords

smoking, alcohol, prevention, prevention & control

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).

Interventions

BEHAVIORALProject 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/.

Sponsors

Pacific Institute for Research and Evaluation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Self-reported 30-day Use of Alcoholmeasured approximately 30 days after intervention completedStudents 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 Cigarettesmeasured approximately 30 days after intervention completedStudents 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 Usemeasured approximately 30 days after intervention completedStudents 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 Usemeasured approximately 30 days after intervention completedStudents 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 Usemeasured approximately 30 days after intervention completedStudents 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 Usemeasured approximately 30 days after intervention completedStudents 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 Usemeasured approximately 30 days after intervention completedStudents 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 Usemeasured approximately 30 days after intervention completedStudents completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).

Countries

United States

Participant flow

Recruitment details

Schools with grades 6-8 who did not currently use an evidence-based substance use prevention program in those grades, and committed themselves to including all their sixth grade students were recruited. Schools were recruited in two cohorts spaced one year apart (2004-2005 and 2005-2006 academic years). Schools from 11 states were enrolled.

Participants by arm

ArmCount
Control Group
School did not receive Project ALERT, a substance use prevention program
4,348
Treatment Group
School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
3,990
Total8,338

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyExcluded/ruled ineligible357129
Overall StudyLost to Follow-up505482
Overall StudyNo parental consent935866

Baseline characteristics

CharacteristicControl GroupTreatment GroupTotal
Age, Categorical
<=18 years
4348 Participants3990 Participants8338 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Sex: Female, Male
Female
2178 Participants2051 Participants4229 Participants
Sex: Female, Male
Male
2170 Participants1939 Participants4109 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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.

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported 30-day Inhalant Use224 participants
Treatment GroupSelf-reported 30-day Inhalant Use239 participants
Primary

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.

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported 30-day Marijuana Use130 participants
Treatment GroupSelf-reported 30-day Marijuana Use116 participants
Primary

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.

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported 30-day Use of Alcohol330 Participants
Treatment GroupSelf-reported 30-day Use of Alcohol332 Participants
Primary

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.

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported 30-day Use of Cigarettes130 participants
Treatment GroupSelf-reported 30-day Use of Cigarettes144 participants
Primary

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).

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported Lifetime Alcohol Use1236 participants
Treatment GroupSelf-reported Lifetime Alcohol Use1288 participants
Primary

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).

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported Lifetime Cigarette Use439 participants
Treatment GroupSelf-reported Lifetime Cigarette Use544 participants
Primary

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).

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported Lifetime Inhalant Use342 participants
Treatment GroupSelf-reported Lifetime Inhalant Use379 participants
Primary

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).

Time frame: measured approximately 30 days after intervention completed

Population: Data were cleaned to remove cases with logical inconsistencies which decreased our sample by 3.6% of respondents at pretest and 7.5% at post-test. Missing covariate data were imputed using the Expectation Maximization (EM) algorithm. Missing data were imputed using the EM algorithms implemented in the Missing Value Analysis module in SPSS 13.0.

ArmMeasureValue (NUMBER)
Control GroupSelf-reported Lifetime Marijuana Use238 participants
Treatment GroupSelf-reported Lifetime Marijuana Use265 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026