A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle … (NCT06115746) | Clinical Trial Compass
RecruitingNot Applicable
A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
United States300 participantsStarted 2023-11-17
Plain-language summary
The primary goal of this study is to test the effectiveness of the iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) curriculum, a novel drug education and diversion program, in approximately 300 middle and high school students, who have violated their school substance use policies in the past month, as an alternative to punitive school responses for school-based substance use infractions. This randomized controlled trial will test the hypothesis that adolescents randomized to the iDECIDE curriculum will have improved substance use outcomes (i.e., knowledge, attitudes, and behavior) compared to adolescents in a waitlist control group. The outcomes of this study will measure knowledge of drug effects and brain development, perceptions of harm from substance use, willingness to quit or reduce use, and substance use behavior.
Who can participate
Age range
9 Years – 22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Currently enrolled in middle or high school;
. Violated school substance use policy within approximately the past month at the time of screening;
. Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18);
. Competent and willing to provide written informed assent (if under the age of 18) or written informed consent (if age 18 or older);
. Able to commit to 9 study visits over approximately one year;
. Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator;
. Has access to a reliable internet connection and a device that can run Zoom;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Knowledge of Drug Effects and Brain Development
Timeframe: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
2
Frequency of Substance Use
Timeframe: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
3
Readiness to Quit or Reduce Substance Use
Timeframe: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
4
Perceived Harm of Substance Use
Timeframe: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)