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NCT Number: NCT05219422

Testing ALERT With GTO in Middle Schools

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

Recruiting

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Key information

Age range

11 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles Unified School District

Los Angeles, California, 90017, United States

Location status: Recruiting

Location contact

Tim Kordic

CONTACT

[email protected]

213-241-3519

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Not meeting eligibility criteria

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

Treatment and study plan

Project ALERT

Behavioral

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

Getting To Outcomes

Behavioral

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.

Primary outcomes

  1. Student alcohol and drug behavior

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

    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).

  2. Student pro-substance use risk factors on consequences

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

    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.

  3. Student resistance self-efficacy

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

    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.

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

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

    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.

  5. Student pro-substance use risk factors on expectancies

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Pedersen, PhD

CONTACT

[email protected]

323-442-4046

Matthew Chinman, PhD

CONTACT

[email protected]

310-393-0411 ext. 4287

Sponsors and collaborators

Lead sponsor

RAND

Other

Collaborators

  • University of Southern California

Registry information

Official study title

Improving the Implementation of Evidence-based Drug Prevention Programs in Schools

Acronym: GTO-ALERT

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Feb 2, 2022
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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