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 |
Trial Parameters
Eligibility Fast-Check
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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/