Project ALERT + Getting To Outcomes for Substance Abuse

(GTO-ALERT Trial)

Overseen By Eric Pedersen, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: RAND

Disqualifiers: Not meeting eligibility criteria

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 years

42 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of Project ALERT, a program designed to prevent substance abuse, both with and without additional support from a tool called Getting To Outcomes (GTO). The researchers aim to determine if this support enhances the program's ability to help students avoid drugs and alcohol. Schools will be divided into groups: some will use Project ALERT alone, some will use it with the extra support, and some will delay its implementation. The trial targets 7th-grade students and interested school staff at participating schools. As an unphased trial, this study provides a unique opportunity to contribute to educational research that could improve substance abuse prevention programs in schools.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that Project ALERT and Getting to Outcomes are safe for use in schools?

Research has shown that Project ALERT is a safe program designed to prevent drug use among teenagers. Studies have found it effectively encourages students to refuse drugs and helps them develop anti-drug attitudes. Schools have reported no major negative effects when using this program.

When combined with Getting to Outcomes (GTO), evidence suggests it further reduces drug and alcohol use among at-risk students, without additional safety concerns. This combination provides extra support and resources to schools, enhancing the program's effectiveness.

In summary, both Project ALERT alone and with GTO are safe for use in schools, with no known negative side effects reported in past studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Project ALERT and the addition of Getting to Outcomes (GTO) because they offer a fresh approach to tackling substance abuse in schools. Unlike traditional programs that might focus solely on information dissemination, Project ALERT emphasizes interactive learning and resistance skills, making it more engaging for students. The integration of GTO adds an evaluation framework, helping schools effectively measure and achieve their prevention goals. This combination not only aims to educate but also empowers schools with tools to track and enhance their program's success, offering a comprehensive strategy for substance abuse prevention.

What evidence suggests that this trial's treatments could be effective for substance abuse?

Studies have shown that Project ALERT effectively reduces drug use among middle school students, specifically lowering smoking and drinking rates in young teens. In this trial, some schools will receive only Project ALERT, while others will receive Project ALERT combined with Getting to Outcomes (GTO), a support tool designed to enhance these effects. Research indicates that this combination can further reduce alcohol and marijuana use among at-risk girls. These findings suggest that both versions of the program could help prevent substance abuse in schools. ^{1 2 5 6 7}

Who Is on the Research Team?

Eric Pedersen, PhD

Principal Investigator

University of Southern California

Matthew Chinman, PhD

Principal Investigator

RAND

Are You a Good Fit for This Trial?

This trial is for 7th-grade students, mostly aged 12-14, who are attending one of the schools participating in the study. School staff at these schools interested in joining the study can also participate.

Inclusion Criteria

Eligibility for school staff participants: all educators interested in enrolling in the study at each of the enrolled schools

I am a 7th grader, aged 12-14, at a participating school.

Exclusion Criteria

Not meeting eligibility criteria

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Schools are randomized to receive Project ALERT or Project ALERT plus GTO for 3 years

3 years

Follow-up

Participants are monitored for changes in substance use risk factors and behaviors

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Getting to Outcomes
• Project ALERT

Trial Overview The trial is evaluating Project ALERT, a substance abuse prevention program, with an added tool called Getting To Outcomes to enhance its effectiveness in middle schools.

How Is the Trial Designed?

Group I: Project ALERT only Active Control 1 Intervention

Some schools will be randomized to receive Project ALERT only for 3 years starting fall 2022.

Group II: Project ALERT plus GTO Active Control 2 Interventions

Some schools will be randomized to receive Project ALERT plus Getting to Outcomes for 3 years starting fall 2022.

Group III: Status quo Active Control 1 Intervention

Some schools not receive either Project ALERT or Project ALERT plus GTO until year 3 of the study.

Who Is Running the Clinical Trial?

RAND

Lead Sponsor

Trials

145

Recruited

617,000+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

The Project ALERT drug prevention program, implemented in eight Pennsylvania middle schools, showed no positive effects on substance use among 1,649 seventh-grade students over a 2-year period and 1-year follow-up.

The study found no differences in program effectiveness based on student risk level, gender, or implementation quality, suggesting that the program may not be effective in this context despite previous validations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of an independent evaluation of Project ALERT delivered in schools by Cooperative Extension. St Pierre, TL., Osgood, DW., Mincemoyer, CC., et al.[2019]

The Project ALERT drug prevention curriculum, when extended to ninth grade with additional booster lessons, effectively reduced alcohol and marijuana use among at-risk girls, highlighting its efficacy in preventing substance misuse.

The program's success was linked to changes in girls' perceptions of social influences and their ability to resist peer pressure, suggesting that addressing these factors can enhance drug prevention efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

School-based drug prevention among at-risk adolescents: effects of ALERT plus. Longshore, D., Ellickson, PL., McCaffrey, DF., et al.[2017]

The Menninger Clinic has implemented a comprehensive outcomes project for adult inpatients, where patients complete standardized assessments at admission, biweekly during treatment, and at discharge, allowing for continuous monitoring of their progress.

This project not only aids in outcomes research but also integrates assessment results into clinical care, enhancing communication between patients and treatment teams, and sets the stage for ongoing follow-up assessments after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating outcomes assessment and research into clinical care in inpatient adult psychiatric treatment. Allen, JG., Frueh, BC., Ellis, TE., et al.[2015]

Project ALERT, a substance use prevention program, was evaluated in a cluster randomized trial involving 5883 middle school students across 34 schools, but it did not show overall effectiveness in reducing substance use among sixth graders.

While there was a statistically significant reduction in past 30-day alcohol use (from an odds ratio of 2.07 to 1.32), the program did not significantly impact the use of cigarettes, marijuana, or inhalants, indicating limited efficacy for the targeted age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project ALERT: a cluster randomized trial. Ringwalt, CL., Clark, HK., Hanley, S., et al.[2019]

A pilot study at Narconon™ of Oklahoma demonstrated an effective routine outcome monitoring (ROM) system using an 18-item telephone survey, which improved follow-up rates from 57.6% to 100% for post-treatment data collection.

The implementation of standardized procedures for staff training and client contact significantly enhanced the quality of care and allowed for better program delivery, ultimately leading to improved substance use and social outcomes for clients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simplified method for routine outcome monitoring after drug abuse treatment. Lennox, RD., Sternquist, MA., Paredes, A.[2021]

The California Treatment Outcome Project (CalTOP) developed an automated outcome monitoring system that effectively tracks client progress and treatment outcomes in the alcohol and other drug (AOD) system, revealing high problem severity at admission and diverse service needs.

Findings indicated that treatment services were often mismatched to client needs, with insufficient retention and length of stay in treatment, suggesting a need for improved service alignment and monitoring to enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot-testing a statewide outcome monitoring system: overview of the California Treatment Outcome Project (CALTOP). Evans, E., Hser, YI.[2019]

Project ALERT, a school-based prevention program for cannabis use, was found to be cost-effective in Sweden, with an incremental cost-effectiveness ratio of €22,384 per quality-adjusted life-year (QALY) over a 20-year follow-up period.

The program showed even greater cost savings (ratio 1:3.2) when focused on boys not engaged in education or work, highlighting its potential effectiveness in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of School-Based Prevention of Cannabis Use. Deogan, C., Zarabi, N., Stenström, N., et al.[2015]

The outcomes management initiative successfully aimed to reduce nosocomial pneumonia in a hospital setting by implementing targeted strategies, including a case-control study and the development of a risk assessment tool.

The article presents both process and outcome data that highlight the positive impact of these strategies, demonstrating their effectiveness in improving patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Managing the outcome of infection: nosocomial infection initiative. Houston, S.[2019]

In a study of 182 patients aged 20-69 with femoral neck fractures treated with internal fixation, 73% of those with displaced fractures and 85% with non-displaced fractures reported good or excellent functional outcomes at 24 months.

Despite a significant percentage achieving good functional outcomes, patients did not fully regain their pre-fracture health-related quality of life, indicating that while surgical intervention is effective, it may not restore overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good functional outcome but not regained health related quality of life in the majority of 20-69 years old patients with femoral neck fracture treated with internal fixation: A prospective 2-year follow-up study of 182 patients. Campenfeldt, P., Hedström, M., Ekström, W., et al.[2018]

Project ALERT, a widely promoted school-based drug prevention program, has been shown to have little effect on actual drug use based on evaluations of three large-scale studies.

Despite its limited effectiveness, Project ALERT remains on evidence-based drug prevention lists due to weak criteria for inclusion, raising concerns about the standards used in evaluating drug prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Making of Evidence-based Practice: The Case of Project ALERT. Gorman, DM., Conde, E.[2021]

Citations

1. projectalert.com projectalert.com/outcomes

The Evidence Behind Project ALERT New inroads in preventing adolescent drug use: Results from a large-scale trial of Project ALERT in middle schools · Modifying pro- drug risk factors in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1448059/

New Inroads in Preventing Adolescent Drug Use 45,46 These early smokers and drinkers have substantially elevated risks for increased drug use and a variety of other high-risk behaviors, such as violence, ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT00650585

NCT00650585 | An Effectiveness Trial of Project ALERT These trials gather additional information about a drug's safety, efficacy, or optimal use. ... Project ALERT is a substance abuse prevention program that targets ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2794139/

The Case of Project ALERT Despite its limited potential as a universal intervention the evaluations may still indicate that ALERT reduces certain types of drug use with certain types of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190740909002217

The making of evidence-based practice: The case ... Ellickson et al. Response to “Preventing adolescent drug use: The effectiveness of Project ALERT”. American Journal of Public Health. (1994). P.L. Ellickson et ...

6. projectalert.com projectalert.com/

Project ALERT Project ALERT is proven to motivate students against drug use, provide skills and strategies to resist drugs, and establish new non-use attitudes and beliefs.

7. ajph.aphapublications.org ajph.aphapublications.org/doi/full/10.2105/AJPH.93.11.1830

New Inroads in Preventing Adolescent Drug Use: Results ... These early smokers and drinkers have substantially elevated risks for increased drug use and a variety of other high-risk behaviors, such as ...