GTO-ALERT: Testing ALERT With GTO in Middle Schools

Sponsor
RAND (Other)
Overall Status
Recruiting
CT.gov ID
NCT05219422
Collaborator
University of Southern California (Other)
42
1
3
27
1.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Project ALERT
  • Behavioral: Getting to Outcomes
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants from 42 schools will be randomized to received Project ALERT, Project ALERT + Getting to Outcomes, or waitlist controlParticipants from 42 schools will be randomized to received Project ALERT, Project ALERT + Getting to Outcomes, or waitlist control
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Improving the Implementation of Evidence-based Drug Prevention Programs in Schools
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Project ALERT only

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

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

Active Comparator: Project ALERT plus GTO

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

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.

No Intervention: Status quo

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

Outcome Measures

Primary Outcome Measures

  1. Changes in student alcohol and drug behavior [Changes assessed for past year use at each follow-up point from baseline]

    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).

  2. Student pro-substance use risk factors (consequences) [Changes assessed for past year consequences of use at each follow-up point from baseline]

    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.

  3. Student pro-substance use risk factors (perceived norms) [Changes assessed for past year perceived peer use at each follow-up point from baseline]

    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.

  4. Student pro-substance use risk factors (expectancies) [Changes assessed for past year use at each follow-up point from baseline]

    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.

  5. Student resistance self-efficacy [Changes assessed for past year self-efficacy use at each follow-up point from baseline]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Los Angeles Unified School District Los Angeles California United States 90017

Sponsors and Collaborators

  • RAND
  • University of Southern California

Investigators

  • Principal Investigator: Matthew Chinman, PhD, RAND
  • Principal Investigator: Eric Pedersen, PhD, University of Southern California

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Matthew Chinman, Senior Behavioral/Social Scientist, RAND
ClinicalTrials.gov Identifier:
NCT05219422
Other Study ID Numbers:
  • 2020-0121-AM01
First Posted:
Feb 2, 2022
Last Update Posted:
Feb 2, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Feb 2, 2022