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Recruiting NCT05219422

Testing ALERT With GTO in Middle Schools

No phase Interventional Substance Abuse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Project ALERT, Getting to Outcomes.
Who it may be relevant to
Registry conditions: Substance Abuse. Basic parameters: 11 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Student alcohol and drug behavior [Time frame: Changes assessed for past year use at each follow-up point from baseline]
  • Student pro-substance use risk factors on consequences [Time frame: Changes assessed for past year consequences of use at each follow-up point from baseline]
  • Student resistance self-efficacy [Time frame: Changes assessed for past year self-efficacy use at each follow-up point from baseline]
  • Student pro-substance use risk factors on perceived norms [Time frame: Changes assessed for past year perceived peer use at each follow-up point from baseline]
  • Student pro-substance use risk factors on expectancies [Time frame: Changes assessed for past year use at each follow-up point from baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Los Angeles Unified School District — Los Angeles

Identifiers

NCT: NCT05219422 · 2020-0121-AM01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗