NCT06115746 A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
| NCT ID | NCT06115746 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Substance Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2023-11-17 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2023-11-17 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Currently enrolled in middle or high school; 2. Violated school substance use policy within approximately the past month at the time of screening; 3. Have a parent or legal guardian who is able and willing to provide written informed consent (if under the age of 18); 4. Competent and willing to provide written informed assent (if under the age of 18) or written informed consent (if age 18 or older); 5. Able to commit to 9 study visits over approximately one year; 6. Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator; 7. Has access to a reliable internet connection and a device that can run Zoom; 8. Able to read and write comfortably in one of the languages spoken by study staff. Exclusion Criteria: 1. Ever received substance use treatment in an inpatient or specialty care setting; 2. Ever engaged in intravenous (IV) drug use; 3. Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06115746 clinical trial?
This trial is open to participants of all sexes, aged 9 Years or older, up to 22 Years, studying Substance Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06115746 currently recruiting?
Yes, NCT06115746 is actively recruiting participants. Contact the research team at rschuster@mgh.harvard.edu for enrollment information.
Where is the NCT06115746 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06115746 clinical trial?
NCT06115746 is sponsored by Massachusetts General Hospital. The trial plans to enroll 300 participants.