Testing ALERT With GTO in Middle Schools (GTO-ALERT)

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

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

Study Overview

• Status: Recruiting
• Conditions: Substance Abuse
• Intervention / Treatment: Behavioral: Project ALERT; Behavioral: Getting to Outcomes

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew Chinman, PhD; Phone Number: 4287 310-393-0411; Email: chinman@rand.org
• Study Contact Backup: Name: Eric Pedersen, PhD; Phone Number: 323-442-4046; Email: Eric.Pedersen@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90017
      • Recruiting
      • Los Angeles Unified School District
      • Contact: Tim Kordic; Phone Number: 213-241-3519; Email: timothy.kordic@lausd.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Project ALERT only; Some schools will be randomized to receive Project ALERT only for 3 years starting fall 2022.	Behavioral: Project ALERT; 14 session drug prevention program for 7th and 8th grade youth.
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; 14 session drug prevention program for 7th and 8th grade youth.; Behavioral: Getting 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.
No Intervention: Status quo; Some schools not receive either Project ALERT or Project ALERT plus GTO until year 3 of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Changes assessed for past year self-efficacy use at each follow-up point from baseline
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).	Changes assessed for past year use at each follow-up point from baseline
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.	Changes assessed for past year consequences of use at each follow-up point from baseline
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.	Changes assessed for past year perceived peer use at each follow-up point from baseline
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.	Changes assessed for past year use at each follow-up point from baseline

Collaborators and Investigators

• Sponsor: RAND
• Collaborators: University of Southern California
• Investigators: Principal Investigator: Matthew Chinman, PhD, RAND; Principal Investigator: Eric Pedersen, PhD, University of Southern California

Publications and helpful links

Helpful Links

• website that contains outcomes measures

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): March 31, 2025

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: January 20, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: 2020-0121-AM01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No