A Randomized Clinical Trial of a Novel Drug Education and Diversion Program (iDECIDE) for Middle and High School Students

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06115746
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
9 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • iDECIDE — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 17, 2023
Status verified
Oct 2025
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
300 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Randi M Schuster, PhD
[email protected]
617-643-6673
Randi M Schuster, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Massachusetts General Hospital· Boston, MA

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