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Project ALERT + Getting To Outcomes for Substance Abuse (GTO-ALERT Trial)
N/A
Recruiting
Led By Eric Pedersen, PhD
Research Sponsored by RAND
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up changes assessed for past year perceived peer use at each follow-up point from baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will test how well Project ALERT works when used with the support enhancement tool, Getting To Outcomes.
Who is the study for?
This trial is for 7th-grade students, mostly aged 12-14, who are attending one of the schools participating in the study. School staff at these schools interested in joining the study can also participate.
What is being tested?
The trial is evaluating Project ALERT, a substance abuse prevention program, with an added tool called Getting To Outcomes to enhance its effectiveness in middle schools.
What are the potential side effects?
Since this trial involves educational interventions rather than medical treatments, there aren't typical side effects like you'd see with medication. However, participants may experience stress or discomfort during discussions about substance use.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ changes assessed for past year use at each follow-up point from baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~changes assessed for past year use at each follow-up point from baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Student alcohol and drug behavior
Student pro-substance use risk factors on consequences
Student pro-substance use risk factors on expectancies
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Active Control
Group I: Project ALERT onlyActive Control1 Intervention
Some schools will be randomized to receive Project ALERT only for 3 years starting fall 2022.
Group II: Project ALERT plus GTOActive Control2 Interventions
Some schools will be randomized to receive Project ALERT plus Getting to Outcomes for 3 years starting fall 2022.
Group III: Status quoActive Control1 Intervention
Some schools not receive either Project ALERT or Project ALERT plus GTO until year 3 of the study.
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Who is running the clinical trial?
RANDLead Sponsor
140 Previous Clinical Trials
614,423 Total Patients Enrolled
University of Southern CaliforniaOTHER
944 Previous Clinical Trials
1,604,603 Total Patients Enrolled
Eric Pedersen, PhDPrincipal InvestigatorUniversity of Southern California
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a 7th grader, aged 12-14, at a participating school.
Research Study Groups:
This trial has the following groups:- Group 1: Project ALERT only
- Group 2: Project ALERT plus GTO
- Group 3: Status quo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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