Clinical trial NCT05219422: Testing ALERT With GTO in Middle Schools
Official title: Improving the Implementation of Evidence-based Drug Prevention Programs in Schools
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Abuse
Lead sponsor: RAND
Sponsor class: OTHER
Collaborators: name: University of Southern California
First posted: 2022-02-02
Enrollment: 42
Sex: ALL
Minimum age (years): 11
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants from 42 schools will be randomized to received Project ALERT, Project ALERT + Getting to Outcomes, or waitlist control
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Student alcohol and drug behavior
timeFrame: Changes assessed for past year use at each follow-up point from baseline
measure: Student pro-substance use risk factors on consequences
timeFrame: Changes assessed for past year consequences of use at each follow-up point from baseline
measure: Student resistance self-efficacy
timeFrame: Changes assessed for past year self-efficacy use at each follow-up point from baseline
measure: Student pro-substance use risk factors on perceived norms
timeFrame: Changes assessed for past year perceived peer use at each follow-up point from baseline
measure: Student pro-substance use risk factors on expectancies
timeFrame: Changes assessed for past year use at each follow-up point from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Unified School District
state: California
Study officials:
affiliation: RAND
name: Matthew Chinman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Eric Pedersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: