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

Primary Purpose

Substance Abuse

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Project ALERT
Getting to Outcomes
Sponsored by
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Abuse

Eligibility Criteria

11 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Los Angeles Unified School DistrictRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Project ALERT only

Project ALERT plus GTO

Status quo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2021
Last Updated
March 13, 2023
Sponsor
RAND
Collaborators
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT05219422
Brief Title
Testing ALERT With GTO in Middle Schools
Acronym
GTO-ALERT
Official Title
Improving the Implementation of Evidence-based Drug Prevention Programs in Schools
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RAND
Collaborators
University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To test the efficacy of Project ALERT with the support enhancement tool, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants from 42 schools will be randomized to received Project ALERT, Project ALERT + Getting to Outcomes, or waitlist control
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Project ALERT only
Arm Type
Active Comparator
Arm Description
Some schools will be randomized to receive Project ALERT only for 3 years starting fall 2022.
Arm Title
Project ALERT plus GTO
Arm Type
Active Comparator
Arm Description
Some schools will be randomized to receive Project ALERT plus Getting to Outcomes for 3 years starting fall 2022.
Arm Title
Status quo
Arm Type
No Intervention
Arm Description
Some schools not receive either Project ALERT or Project ALERT plus GTO until year 3 of the study.
Intervention Type
Behavioral
Intervention Name(s)
Project ALERT
Intervention Description
14 session drug prevention program for 7th and 8th grade youth.
Intervention Type
Behavioral
Intervention Name(s)
Getting to Outcomes
Intervention Description
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 Outcome Measure Information:
Title
Student alcohol and drug behavior
Description
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
Title
Student pro-substance use risk factors on consequences
Description
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
Title
Student resistance self-efficacy
Description
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
Title
Student pro-substance use risk factors on perceived norms
Description
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
Title
Student pro-substance use risk factors on expectancies
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Chinman, PhD
Phone
310-393-0411
Ext
4287
Email
chinman@rand.org
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Pedersen, PhD
Phone
323-442-4046
Email
Eric.Pedersen@med.usc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Chinman, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Pedersen, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Los Angeles Unified School District
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Kordic
Phone
213-241-3519
Email
timothy.kordic@lausd.net

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.projectalert.com/
Description
website that contains outcomes measures

Learn more about this trial

Testing ALERT With GTO in Middle Schools

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