Testing ALERT With GTO in Middle Schools

Substance Abuse Clinical Trial

— GTO-ALERT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05219422
• Other study ID #: 2020-0121-AM01
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: RAND
• Contact: Matthew Chinman, PhD
• Phone: 310-393-0411
• Email: chinman[@]rand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: March 31, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Substance Abuse
• Substance-Related Disorders

Intervention

Behavioral:
• Project ALERT
14 session drug prevention program for 7th and 8th grade youth.
• 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.

Locations

Country	Name	City	State
United States	Los Angeles Unified School District	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
RAND	University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External Links

•   website that contains outcomes measures