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Active, not recruitingNCT05219422GTO-ALERTUpdated Aug 20, 2026

Testing ALERT With GTO in Middle Schools

An interventional study of Project ALERT and Getting to Outcomes in Substance Abuse, sponsored by RAND. Active, not recruiting at 1 site in United States. Open to participants aged 11 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by RAND · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
11 Years to 70 Years
Sex
All
01

Study summary

To test the efficacy of Project ALERT with the support enhancement tool, Getting To Outcomes.

Read the detailed description

This study combines two programs that have been developed by RAND researchers: Project ALERT (PA) and Getting to Outcomes (GTO). Project ALERT is a widely used drug prevention program for middle school youth. Though it has an evidence-base for effectiveness, the program (like most evidence-based programs in schools) is not run with adequate fidelity representing a large gap between what is developed and tested for effectiveness and what is used in actual practice. Thus, the study will conduct an updated randomized controlled trial of PA and test GTO as a tool to increase adoption and adequate fidelity of the program in schools. GTO's previous evidence suggests it could be effective in public schools, yet this remains an empirical question. A successful demonstration of PA and GTO could fundamentally transform evidence-based prevention's delivery, reach, and thus impact, in the US.

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Conditions studied

  • Substance Abuse
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In context

Substance-Related Disorders

2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.

This study's planned enrollment of 42 is below the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.

Browse Substance-Related Disorders studies →

Lead sponsor

RAND is the lead sponsor of 110 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
11 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Eligibility for student participants: all students in 7th grade, primarily aged 12-14, attending school at one of the enrolled schools in the study.
  • Eligibility for school staff participants: all educators interested in enrolling in the study at each of the enrolled schools.

Exclusion criteria

Exclusion Criteria:

  • Not meeting eligibility criteria

Note: the age range is from 11 to 70 to account for both the student AND teacher populations.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
42 participants (estimated)

Study arms

  • Active comparator
    Project ALERT only

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

    Behavioral: Project ALERT

  • Active comparator
    Project ALERT plus GTO

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

    Behavioral: Project ALERT · Behavioral: Getting to Outcomes

  • No intervention
    Status quo

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

Interventions

  • BehavioralProject ALERT

    14 session drug prevention program for 7th and 8th grade youth.

  • BehavioralGetting to Outcomes

    The Getting To Outcomes (GTO) implementation support intervention provides technical assistance, training, guides, and tools to improve community-based practitioners capacity to complete tasks associated with implementing an EBP, which in turn leads to improved implementation fidelity.

06

What researchers measure

Primary outcomes

  1. Student alcohol and drug behavior

    Alcohol and drug use will be assessed for alcohol, cigarettes, marijuana, e-cigarettes, prescription opioids, and heroin (lifetime, past month, past year use), allowing us to evaluate program effects on ever, past month, and weekly use. We will assess marijuana and nicotine using items to capture nuanced products (e.g., JUUL/vape pens) and include combinations of marijuana/nicotine products to assess co-use, such as using a vaporizer to vape both nicotine e-liquid and cannabis oil. For alcohol, we will ask questions that allow us to construct 3 alcohol misuse scales: (1) alcohol-related consequences (sum of 5 dichotomous questions on: getting sick, getting in a physical fight, getting in trouble at school, getting in trouble at home, doing something he/she later regretted); (2) high-risk drinking (sum of 3 dichotomous variables: binge drinking in the past month, polydrug use of alcohol and marijuana in the past year, weekly drinking); and (3) overall misuse (sum of above 8 variables).

    Time frame: Changes assessed for past year use at each follow-up point from baseline

  2. Student pro-substance use risk factors on consequences

    Beliefs about the short- and long-term consequences (positive and negative). Measures come from the Project ALERT survey posted on the Project ALERT website and utilized in the 4 prior RCTs of Project ALERT.

    Time frame: Changes assessed for past year consequences of use at each follow-up point from baseline

  3. Student resistance self-efficacy

    Resistance self-efficacy from the Project ALERT survey measures avoiding use of all 6 drugs in risky situations. Measure is posted on the Project ALERT website and utilized in the 4 prior RCTs of Project ALERT.

    Time frame: Changes assessed for past year self-efficacy use at each follow-up point from baseline

  4. Student pro-substance use risk factors on perceived norms

    Normative beliefs about the prevalence of use and its acceptability to others, including peers and parents. Measures come from the Project ALERT survey posted on the Project ALERT website and utilized in the 4 prior RCTs of Project ALERT.

    Time frame: Changes assessed for past year perceived peer use at each follow-up point from baseline

  5. Student pro-substance use risk factors on expectancies

    Expectations of drug use in the next 6 months. Measures come from the Project ALERT survey posted on the Project ALERT website and utilized in the 4 prior RCTs of Project ALERT.

    Time frame: Changes assessed for past year use at each follow-up point from baseline

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Study locations

1 site
  • Los Angeles Unified School District
    Los Angeles, California 90017, United States
08

References and documents

Study documents

  • Informed consent form · Sep 7, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05219422
Lead sponsor
RAND
Collaborators
University of Southern California
Responsible party
Matthew Chinman (Senior Behavioral/Social Scientist, RAND) — Principal investigator
First posted
Feb 2, 2022
Start date
Aug 30, 2022
Primary completion
Jul 1, 2026
Completion
Mar 31, 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Matthew Chinman, PhD
principal investigator · RAND
Eric Pedersen, PhD
principal investigator · University of Southern California

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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