A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students
2 other identifiers
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 3, 2023
CompletedStudy Start
First participant enrolled
November 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2028
October 30, 2025
October 1, 2025
4.7 years
October 30, 2023
October 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Knowledge of Drug Effects and Brain Development
Knowledge of drug effects and brain development will be measured with a multiple choice questionnaire that assesses knowledge taught in the iDECIDE curriculum, including neurobiology of addiction, side effects of substance, and industry tactics to market substances to young audiences.
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Frequency of Substance Use
The Timeline Follow-Back (TLFB) will be used to measure number of days the participant used a substance, which substances were used, and the frequency of which substances were used. The initial TLFB at the baseline visit will measure substances used in the past 90 days, while the interim TLFB will measure substances used since each subsequent visit. Participants will also provide a urine sample at study visits 1, 5, 6, 7 to qualitatively screen for substances including amphetamines, cocaine, barbiturates, methamphetamines, benzodiazepines, opiates, marijuana, phencyclidine, propoxyphene, and methaqualone using a urine 10-panel. There will also be an assay to quantitate levels of cotinine and creatinine-adjusted carboxy THC at baseline, end-of-intervention, one-week follow-up, and one-month follow-up. The primary outcome will be change in frequency of past week use (number of days) for the substance used most frequently at baseline.
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Readiness to Quit or Reduce Substance Use
Participants will complete a Readiness Ruler to determine how ready they are to reduce their substance use on a scale from 1 (not at all ready) to 10 (very ready).
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Perceived Harm of Substance Use
The Perceived Harm of Substance Use measure was modified from the 2010 National Survey on Drug Use and Health. Participants will assess their perceived harm of various forms of substance use using four response categories that range from no risk to great risk.
Baseline to 1-month follow-up (primary), 6-month and 1-year follow-up (exploratory)
Study Arms (2)
iDECIDE
EXPERIMENTALParticipants 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.
Waitlist Control Group
NO INTERVENTIONParticipants 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 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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Massachusetts Department of Healthcollaborator
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Related Publications (2)
Liu J, Butler R, Turncliff A, Gray C, Lynch S, Whittaker J, Iroegbulem V, Howell D, Schuster RM. An Urgent Need for School-Based Diversion Programs for Adolescent Substance Use: A Statewide Survey of School Personnel. J Adolesc Health. 2023 Sep;73(3):428-436. doi: 10.1016/j.jadohealth.2023.04.006. Epub 2023 Jun 15.
PMID: 37318411BACKGROUNDSchuster RM, Cather C, Pachas GN, Nielsen L, Iroegbulem V, Dufour J, Potter K, Levy S, Gray KM, Evins AE. A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol. Front Psychiatry. 2023 Mar 15;14:1083791. doi: 10.3389/fpsyt.2023.1083791. eCollection 2023.
PMID: 37009114BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Eligible participants will be randomly assigned at the end of the baseline visit in a 1:1 ratio, in blocks of 6, to either a waitlist control group or the iDECIDE curriculum group. Randomization will be stratified by substance use frequency. Treatment will be assigned according to study number, assigned sequentially to eligible participants who enroll in the trial and attend the baseline visit. Investigators and outcome assessors will be fully blinded to allocation across the two arms. Facilitators of the iDECIDE curriculum will not be involved with the data outcome assessments.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 3, 2023
Study Start
November 17, 2023
Primary Completion (Estimated)
July 31, 2028
Study Completion (Estimated)
July 31, 2028
Last Updated
October 30, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Beginning 3 months and ending 5 years following article publication
- Access Criteria
- Researchers who provide a methodologically sound proposal to achieve aims in the approved proposal. Data access agreement required.
Individual participant data that underlie reported results (after de-identification \[text, tables, figures, and appendices\]), and the study protocol, statistical analysis plan, analytic code, and informed consent form will be made available to researchers who provide a methodologically sound proposal beginning 3 months and ending 5 years following article publication to achieve aims in the approved proposal. Proposals should be directed to rschuster@harvard.mgh.edu. To gain access, data requestors will need to sign a data access agreement.