Recruiting

Drug Education

Sponsor:

Massachusetts General Hospital

Code:

NCT06115746

Conditions

Substance Use

Harm Reduction

Adolescent Behavior

Eligibility Criteria

Sex: All

Age: 9 - 22

Healthy Volunteers: Not accepted

Interventions

iDECIDE

Study Details

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.

Conditions

Substance Use

Harm Reduction

Adolescent Behavior

Study ID

NCT06115746

Start date

Nov 17, 2023

Status verified date

Oct, 2025

Completion date

Jul 31, 2028

Anticipated

Primary completion date

Jul 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 22

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: iDECIDE

Participants will…

1. Receive 4 weekly sessions of the iDECIDE drug curriculum.
2. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis visits.
3. Be video recorded for quality control.

no intervention: Waitlist Control Group

Participants will…

1. Not receive the iDECIDE curriculum during the weekly visits. They can choose to self-enroll in the iDECIDE curriculum at their one-month follow up visit.
2. Undergo symptom monitoring during the weekly visits.
3. Complete assessments and questionnaires, including self-reports of substance use and 4 urinalysis visits.

Interventions

iDECIDE

iDECIDE is a 4-session drug education and diversion program that addresses topics such as the neurobiology and addiction, adolescent brain development, industry tactics, motives for using substances, risk and protective factors, identifying triggers, healthy alternatives, core values, and long-term goal setting. These topics are taught via facilitated discussions, videos, worksheets, and handouts. The iDECIDE drug curriculum will be delivered weekly for 4 weeks via videoconference or in-person visits. Each session typically takes 60-75 minutes. For this study, facilitators are members of study staff.

Primary outcome measure

  • Knowledge of Drug Effects and Brain Development [ Time Frame: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory) ]
  • Frequency of Substance Use [ Time Frame: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory) ]
  • Readiness to Quit or Reduce Substance Use [ Time Frame: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory) ]
  • Perceived Harm of Substance Use [ Time Frame: Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory) ]

Central Contacts and Locations

Central contacts

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Randi M Schuster, PhD

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 30, 2025

Last verified

Oct, 2025

Keywords

  • Adolescent
  • Diversion program
  • iDECIDE
  • Tier 2
  • School
  • Substance use prevention
  • Addiction
  • Early intervention
  • Targeted prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-10-30.