Status:
RECRUITING
A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Massachusetts Department of Health
Conditions:
Substance Use
Harm Reduction
Eligibility:
All Genders
9-22 years
Phase:
NA
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 progra...
Detailed Description
This study will be a two-arm, assessor-blind, randomized controlled trial enrolling approximately 300 middle and high school students who have recently violated a school substance use policy. Particip...
Eligibility Criteria
Inclusion
- 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;
- Able to read and write comfortably in one of the languages spoken by study staff.
Exclusion
- Ever received substance use treatment in an inpatient or specialty care setting;
- Ever engaged in intravenous (IV) drug use;
- Current daily use of alcohol, non-medical benzodiazepines, and/or opioid use.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06115746
Start Date
November 17 2023
End Date
July 31 2028
Last Update
October 30 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114