Trial Outcomes & Findings for An Effectiveness Trial of Project ALERT (NCT NCT00650585)

NCT ID: NCT00650585

Last Updated: 2013-06-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8338 participants
• Primary outcome timeframe: measured approximately 30 days after intervention completed
• Results posted on: 2013-06-13

Participant Flow

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.

Participant milestones

Measure	Control Group School did not receive Project ALERT, a substance use prevention program	Treatment Group School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Overall Study STARTED	4348	3990
Overall Study COMPLETED	2551	2513
Overall Study NOT COMPLETED	1797	1477

Reasons for withdrawal

Measure	Control Group School did not receive Project ALERT, a substance use prevention program	Treatment Group School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Overall Study Lost to Follow-up	505	482
Overall Study No parental consent	935	866
Overall Study Excluded/ruled ineligible	357	129

Baseline Characteristics

An Effectiveness Trial of Project ALERT

Baseline characteristics by cohort

Measure	Control Group n=4348 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=3990 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year	Total n=8338 Participants Total of all reporting groups
Age, Categorical <=18 years	4348 Participants n=93 Participants	3990 Participants n=4 Participants	8338 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	2178 Participants n=93 Participants	2051 Participants n=4 Participants	4229 Participants n=27 Participants
Sex: Female, Male Male	2170 Participants n=93 Participants	1939 Participants n=4 Participants	4109 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported 30-day Use of Alcohol	330 Participants	332 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported 30-day Use of Cigarettes	130 participants	144 participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported 30-day Marijuana Use	130 participants	116 participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported 30-day Inhalant Use	224 participants	239 participants

PRIMARY outcome

Timeframe: 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.

Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used alcohol (yes or no).

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported Lifetime Alcohol Use	1236 participants	1288 participants

PRIMARY outcome

Timeframe: 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.

Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever smoked cigarettes (yes or no).

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported Lifetime Cigarette Use	439 participants	544 participants

PRIMARY outcome

Timeframe: 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.

Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used marijuana (yes or no).

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported Lifetime Marijuana Use	238 participants	265 participants

PRIMARY outcome

Timeframe: 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.

Students completed an 81-item self-report questionnaire. To assess lifetime use, we asked if the respondent had ever used inhalants (yes or no).

Outcome measures

Measure	Control Group n=2358 Participants School did not receive Project ALERT, a substance use prevention program	Treatment Group n=2324 Participants School received Project ALERT, a substance use prevention program with 11 lessons the first year and 3 booster lessons the second year
Self-reported Lifetime Inhalant Use	342 participants	379 participants

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Heddy Clark

PIRE

Phone: 919-265-2643

Email: hclark@pire.org

Results disclosure agreements

• Principal investigator is a sponsor employee All reports and products must be submitted for review prior to publication.
• Publication restrictions are in place

Restriction type: OTHER