Actively Recruiting

Phase Not Applicable
Age: 9Years - 22Years
All Genders
ID06115746

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

Led by Massachusetts General Hospital · Updated on 2025-10-30

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

M

Massachusetts Department of Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the iDECIDE curriculum, a new drug education and diversion program, in about 300 middle and high school students who have recently broken school substance use rules. This randomized controlled trial aims to see if iDECIDE improves knowledge about drugs, attitudes toward substance use, and actual substance use behavior compared to a waitlist control group. The study focuses on adolescents' understanding of drug effects, brain development, and readiness to reduce or quit substance use. Participants will be randomly assigned to one of two groups: the iDECIDE group or a waitlist control group. The iDECIDE group will complete four weekly sessions of a drug education curriculum, delivered via videoconference or in-person, each lasting 60 to 75 minutes. This curriculum covers topics such as addiction neurobiology, brain development, industry tactics, and healthy alternatives. The control group will undergo symptom and substance use monitoring during the weekly visits and may choose to join the iDECIDE program after one month. The study involves nine visits over about one year, including baseline assessment, four weekly intervention or monitoring visits, and four follow-up visits at one week, one month, six months, and one year after the intervention. Participants will complete questionnaires, assessments, and urine tests at various visits, with raters blinded to group assignment. The study will measure knowledge of drug effects and brain development, frequency of substance use, readiness to quit, and perceptions of harm. Participants will receive compensation for attending sessions and providing urine samples.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 9Years - 22Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Currently enrolled in middle or high school
  • Violated school substance use policy within approximately the past month at screening
  • Has a parent or legal guardian able and willing to provide written consent if under 18
  • Able and willing to provide written assent if under 18, or consent if 18 or older
  • Able to commit to 9 study visits over about one year
  • Considered safe for outpatient participation by the investigator
  • Has access to reliable internet and a device that can run Zoom
  • Able to read and write comfortably in a language spoken by study staff
Not Eligible

You will not qualify if you...

  • Ever received substance use treatment in inpatient or specialty care setting
  • Ever engaged in intravenous (IV) drug use
  • Current daily use of alcohol, non-medical benzodiazepines, or opioids

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Treatment

Duration - 4 weeks

Participants receive either 4 weekly sessions of the iDECIDE drug education curriculum via videoconference or in-person visits, or undergo symptom and substance use monitoring if assigned to the waitlist control group.

4 weekly visits

Follow-up

Duration - Approximately 1 year

Participants complete assessments at approximately 1 week, 1 month, 6 months, and 1 year after the end of the intervention to monitor knowledge, substance use, and readiness to change.

4 follow-up visits

Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

R

Randi M Schuster, PhD

K

Kendall Roberts

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

An Urgent Need for School-Based Diversion Programs for Adolescent Substance Use: A Statewide Survey of School Personnel.

Jessica Liu, Rebecca Butler, Amy Turncliff...

https://pubmed.ncbi.nlm.nih.gov/37318411

A randomized controlled trial of varenicline and brief behavioral counseling delivered by lay counselors for adolescent vaping cessation: Study protocol.

Randi M Schuster, Corinne Cather, Gladys N Pachas...

https://pubmed.ncbi.nlm.nih.gov/37009114