NCT05219422

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
10mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Aug 2022Mar 2027

First Submitted

Initial submission to the registry

September 14, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 2, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

August 30, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

September 14, 2021

Last Update Submit

May 12, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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 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 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

Study Arms (3)

Project ALERT only

ACTIVE COMPARATOR

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

Behavioral: Project ALERT

Project ALERT plus GTO

ACTIVE COMPARATOR

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

Behavioral: Project ALERTBehavioral: Getting to Outcomes

Status quo

NO INTERVENTION

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

Interventions

Project ALERTBEHAVIORAL

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

Project ALERT onlyProject ALERT plus GTO

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.

Project ALERT plus GTO

Eligibility Criteria

Age11 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Not meeting eligibility criteria
  • Note: the age range is from 11 to 70 to account for both the student AND teacher populations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Los Angeles Unified School District

Los Angeles, California, 90017, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Matthew Chinman, PhD

    RAND

    PRINCIPAL INVESTIGATOR
  • Eric Pedersen, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Chinman, PhD

CONTACT

Eric Pedersen, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants from 42 schools will be randomized to received Project ALERT, Project ALERT + Getting to Outcomes, or waitlist control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Behavioral/Social Scientist

Study Record Dates

First Submitted

September 14, 2021

First Posted

February 2, 2022

Study Start

August 30, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations