Substance AbuseGTO-ALERTNCT05219422
Testing ALERT With GTO in Middle Schools
A study testing Project ALERT and Getting to Outcomes in people with Substance Abuse, run by RAND at 1 site in United States.
Trial summary
To test the efficacy of Project ALERT with the support enhancement tool, Getting To Outcomes. Read more about this study
- Who is it for?
- Ages 11 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse
- What is being tested?
- Project ALERT and Getting to Outcomes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2022to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Not meeting eligibility criteria
- Note: the age range is from 11 to 70 to account for both the student AND teacher populations.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles Unified School District
Los Angeles, California, 90017
About this study
Official title: Improving the Implementation of Evidence-based Drug Prevention Programs in Schools
To test the efficacy of Project ALERT with the support enhancement tool, Getting To Outcomes.
Read the 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.
- Conditions
- Substance Abuse
- Being tested
- Project ALERT, Getting to Outcomes
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project ALERTBehavioural
14 session drug prevention program for 7th and 8th grade youth.
Getting to OutcomesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Project ALERT only | Active comparator | Some schools will be randomized to receive Project ALERT only for 3 years starting fall 2022. Receives: 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. Receives: Behavioral: Project ALERT; Behavioral: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Changes assessed for past year use at each follow-up point from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start30 Aug 2022
- Primary completion1 Jul 2026
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants from 42 schools will be randomized to received Project ALERT, Project ALERT + Getting to Outcomes, or waitlist control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Matthew Chinman, RAND
- Investigators
- Matthew Chinman, PhD, Principal investigator, RANDEric Pedersen, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219422
- Sponsor's protocol ID
- 2020-0121-AM01
- Acronym
- GTO-ALERT
- Status last verified
- May 2026
- First submitted
- 14 Sep 2021
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Implementation of Evidence-based Drug Prevention Programs in Schools
- ClinicalTrials.gov ID
- NCT05219422
- Acronym / sponsor ID
- GTO-ALERT / 2020-0121-AM01
- Conditions
- Substance Abuse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- University of Southern California
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Participants from 42 schools will be randomized to received Project ALERT, Project ALERT + Getting to Outcomes, or waitlist control
| Arm | Type | Receives |
|---|---|---|
| Project ALERT only | Active comparator | Behavioral: Project ALERTSome schools will be randomized to receive Project ALERT only for 3 years starting fall 2022. |
| Project ALERT plus GTO | Active comparator | Behavioral: Project ALERT, Behavioral: Getting to OutcomesSome schools will be randomized to receive Project ALERT plus Getting to Outcomes for 3 years starting fall 2022. |
| Status quo | No intervention | –Some schools not receive either Project ALERT or Project ALERT plus GTO until year 3 of the study. |
Who may qualify
- Ages
- 11 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Not meeting eligibility criteria
- Note: the age range is from 11 to 70 to account for both the student AND teacher populations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Project ALERT14 session drug prevention program for 7th and 8th grade youth. | Behavioural | Project ALERT only, Project ALERT plus GTO |
| Getting to OutcomesThe 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. | Behavioural | Project ALERT plus GTO |
Primary outcome
Student alcohol and drug behavior
Time frame: 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).
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
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
Time frame: 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.
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
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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- website that contains outcomes measuresLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Chinman, PhD principal investigator
RAND
Eric Pedersen, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project ALERT and Getting to Outcomes in people with Substance Abuse, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Student alcohol and drug behavior (time frame: Changes assessed for past year use at each follow-up point from baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.