Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School… (NCT05321563) | Clinical Trial Compass
TerminatedNot Applicable
Evaluating the Effectiveness of a Drug Education and Diversion Program for Middle and High School Students
Stopped: Due to changes in state policy, the need for a comprehensive Tier 2 diversion program became apparent. The PI and Project Officer at MA DPH opened up programming statewide and updated the evaluation plan (NCT06115746).
United States132 participantsStarted 2022-02-04
Plain-language summary
The primary goal of this study is to evaluate the effectiveness of the iDECIDE curriculum as an alternative to punitive responses for school-based substance use infractions.
Who can participate
Age range
10 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.
Eligibility criteria for the primary aim (i.e., evaluating how student-level outcomes change when schools transition from a standard disciplinary response to having access to a more educational and therapeutic alternative):
Inclusion Criteria:
* Enrolled in a participating middle or high school;
* Received a substance use-related infraction at school or school-sanctioned event;
* 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 consent (if age 18+) or assent (if under 18);
* Able to read and write comfortably in English;
* In the opinion of the investigator, able to safely participate in the protocol.
Exclusion Criteria:
* Passive consent for referral to MGH evaluation team declined by parent or legal guardian;
* Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
* Ward of the state.
Eligibility criteria for participants for exploratory aims:
In addition to the students with school-based substance use infractions enrolled for the primary aims, three additional cohorts of participants will be recruited for exploratory aims. The eligibility criteria for these cohorts are listed below.
Exploratory Aim 1: evaluating the impact of transition from punitive responses for substance use to iDECIDE on overall prevalence of substance use and perceptions of school culture (…
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 from baseline to 90 day follow-up
Timeframe: Baseline - 90 days
2
Frequency of substance use from baseline to 90 day follow-up